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part of the document
Specialist Medical Review Council
Reasons for Decisions
Section 196W Veterans Entitlements Act 1986
Re: Statements of Principles concerning lumbar spondylosis Nos. 37 & 38 of 2005
as amended by Statements of Principles Nos. 78 & 79 of 2008 and 36 & 37 of 2010
Request for Review Declaration No.19
TABLE OF CONTENTS
TOC \o "1-2" \h \z \u HYPERLINK \l "_Toc359507798" SUMMATION PAGEREF _Toc359507798 \h 3
HYPERLINK \l "_Toc359507799" THE SPECIALIST MEDICAL REVIEW COUNCIL PAGEREF _Toc359507799 \h 3
HYPERLINK \l "_Toc359507800" THE LEGISLATION PAGEREF _Toc359507800 \h 4
HYPERLINK \l "_Toc359507801" BACKGROUND PAGEREF _Toc359507801 \h 6
HYPERLINK \l "_Toc359507802" First Application for review by the Council PAGEREF _Toc359507802 \h 6
HYPERLINK \l "_Toc359507803" The information sent by the RMA to the Council - First Application PAGEREF _Toc359507803 \h 7
HYPERLINK \l "_Toc359507804" Amendments to Statements of Principles PAGEREF _Toc359507804 \h 7
HYPERLINK \l "_Toc359507805" Second Application for review by the Council PAGEREF _Toc359507805 \h 8
HYPERLINK \l "_Toc359507806" The information sent by the RMA to the Council - Second Application PAGEREF _Toc359507806 \h 9
HYPERLINK \l "_Toc359507807" Second Applicant's Position PAGEREF _Toc359507807 \h 9
HYPERLINK \l "_Toc359507808" Notification of Preliminary Decisions on Proposed Scope of Review and Proposed Pool of Information PAGEREF _Toc359507808 \h 9
HYPERLINK \l "_Toc359507809" Proposed Scope of Review PAGEREF _Toc359507809 \h 10
HYPERLINK \l "_Toc359507810" Proposed Pool of Information PAGEREF _Toc359507810 \h 10
HYPERLINK \l "_Toc359507811" FIRST APPLICANTS SUBMISSIONS and comments on the Proposed Scope of the Review and Proposed Pool of Information decisions PAGEREF _Toc359507811 \h 11
HYPERLINK \l "_Toc359507812" second Applicant's submissions and comments on the Proposed Scope of the Review and Proposed Pool of Information decisions PAGEREF _Toc359507812 \h 13
HYPERLINK \l "_Toc359507813" COMMISSIONS SUBMISSIONS and comments on the Proposed Scope of the Review and Proposed Pool of Information decisions PAGEREF _Toc359507813 \h 13
HYPERLINK \l "_Toc359507814" Commissions submissions on 'flexion, extension, twisting of the spine' PAGEREF _Toc359507814 \h 14
HYPERLINK \l "_Toc359507815" Commissions submissions on flight factors PAGEREF _Toc359507815 \h 22
HYPERLINK \l "_Toc359507816" Revised proposed Scope of Review and Revised proposed Pool of information PAGEREF _Toc359507816 \h 23
HYPERLINK \l "_Toc359507817" Final Scope of Review PAGEREF _Toc359507817 \h 24
HYPERLINK \l "_Toc359507818" Final Pool of Information PAGEREF _Toc359507818 \h 24
HYPERLINK \l "_Toc359507819" REASONS FOR THE COUNCILS DECISION PAGEREF _Toc359507819 \h 25
HYPERLINK \l "_Toc359507820" The Councils Task PAGEREF _Toc359507820 \h 25
HYPERLINK \l "_Toc359507821" DOES THE SOUND MEDICAL - SCIENTIFIC EVIDENCE, 'POINT TO' OR 'LEAVE OPEN' THE RELEVANT ASSOCIATION? PAGEREF _Toc359507821 \h 26
HYPERLINK \l "_Toc359507822" THE COUNCIL'S ANALYSIS OF THE INFORMATION BEFORE THE RMA PAGEREF _Toc359507822 \h 26
HYPERLINK \l "_Toc359507823" Preliminary comment on lumbar spondylosis PAGEREF _Toc359507823 \h 26
HYPERLINK \l "_Toc359507824" General observations PAGEREF _Toc359507824 \h 27
HYPERLINK \l "_Toc359507825" THE REVIEW COUNCIL'S ANALYSIS OF THE INFORMATION IT CONSIDERED MOST IMPORTANT AS BEING POTENTIALLY REFERABLE TO THE CONTENDED FACTORS for 'Repetitive or persistent flexion, extension or twisting of the lumbar spine.' PAGEREF _Toc359507825 \h 29
HYPERLINK \l "_Toc359507826" Summary of the Council's consideration of the sound medical scientific evidence on Lumbar Spondylosis and flexion, extension and twisting. PAGEREF _Toc359507826 \h 56
HYPERLINK \l "_Toc359507827" THE COUNCILS CONCLUSIONS ON THE SOUND MEDICAL-SCIENTIFIC EVIDENCE PAGEREF _Toc359507827 \h 58
HYPERLINK \l "_Toc359507828" THE COUNCILS CONCLUSIONS ON WHETHER THERE SHOULD BE A FACTOR(S) FOR PERSISTENT (PROLONGED, FORWARD) FLEXION AND REPETITIVE EXTENSION OR TWISTING. PAGEREF _Toc359507828 \h 59
HYPERLINK \l "_Toc359507829" NEW INFORMATION SUBMITTED BY THE APPLICANT PAGEREF _Toc359507829 \h 59
HYPERLINK \l "_Toc359507830" DECISION PAGEREF _Toc359507830 \h 60
HYPERLINK \l "_Toc359507831" EVIDENCE BEFORE THE COUNCIL PAGEREF _Toc359507831 \h 60
HYPERLINK \l "_Toc359507832" Glossary of Terms: PAGEREF _Toc359507832 \h 61
HYPERLINK \l "_Toc359507833" APPENDIX A PAGEREF _Toc359507833 \h 65
HYPERLINK \l "_Toc359507834" Appendix B PAGEREF _Toc359507834 \h 70
HYPERLINK \l "_Toc359507835" APPENDIX C PAGEREF _Toc359507835 \h 92
SUMMATION
In relation to the Repatriation Medical Authority (the RMA) Statement of Principles concerning lumbar spondylosis No. 37 of 2005, as amended by Statement of Principles No. 78 of 2008 and Statement of Principles No. 36 of 2010, made under subsections 196B(2) and (8) of the Veterans' Entitlements Act 1986 (the VEA), the Specialist Medical Review Council (the Council) under subsection 196W of the VEA:
DECLARES that there is sound medical-scientific evidence on which the RMA could have relied to amend the Statement of Principles to include the factor/s set out below;
DIRECTS the RMA to amend Statement of Principles concerning lumbar spondylosis No. 37 of 2005, as amended by Statement of Principles No. 78 of 2008 and Statement of Principles No. 36 of 2010 by including factors:
for extreme prolonged forward flexion/bending for a cumulative total of at least 1500 hours.
AND DECLARES that the sound medical-scientific evidence available to the RMA is insufficient to justify any amendment to the Statement of Principles to include a factor for repetitive extension or twisting of the lumbar spine.
In relation to the RMA Statement of Principles concerning lumbar spondylosis No. 38 of 2005, as amended by Statement of Principles No. 79 of 2008 and Statement of Principles No. 37 of 2010, made under subsections 196B(3) and (8) of the VEA the Council under subsection 196W of the VEA:
DECLARES that there is sound medical-scientific evidence on which the RMA could have relied to amend the Statement of Principles to include the factor/s set out below;
DIRECTS the RMA to amend Statement of Principles concerning lumbar spondylosis No. 38 of 2005, as amended by Statement of Principles No. 79 of 2008 and Statement of Principles No. 37 of 2010 by including factors:
for extreme/prolonged forward flexion/bending for a cumulative total of at least 1500 hours.
AND DECLARES that the sound medical-scientific evidence available to the RMA is insufficient to justify any amendment to the Statement of Principles to include a factor for repetitive extension or twisting of the lumbar spine.
THE SPECIALIST MEDICAL REVIEW COUNCIL
The Council is a body corporate established under section 196V of the VEA, and consists of such number of members as the Minister for Veterans' Affairs determines from time to time to be necessary for the proper exercise of the function of the Council as set out in the VEA. The Minister must appoint one of the Councillors to be the Convener. When appointing Councillors, the Minister is required to have regard to the branches of medical science that would be necessary for deciding matters referred to the Council for review.
When a review is undertaken the Council is constituted by three to five Councillors selected by the Convener. If the Review Council as constituted for the purposes of a review does not include the Convener, the Convener must appoint one of the Councillors selected for the purposes of the review to preside at all meetings of the Council as so constituted as Presiding Councillor.
Dr David Newman was the Presiding Councillor for this review. Dr Newman spent over 12 years in the Royal Australian Air Force as a medical officer and aviation medicine specialist. He is currently Senior Lecturer and Head of Research in the Aviation Discipline in the Faculty of Engineering and Industrial Sciences at Swinburne University in Victoria and head of the Aviation Medicine Unit in the Department of Epidemiology and Preventive Medicine at Monash University.
The other members of the Review Council for the purposes of the review were:
Professor Robert Cumming
Professor Cumming is Professor of Epidemiology and Geriatric Medicine, School of Public Health University of Sydney, and researcher at the Centre for Education and Research on Ageing at Concord Hospital.
Associate Professor John Hart
Associate Professor Hart is an orthopaedic surgeon based in Melbourne. He was head of the orthopaedic unit at the Alfred Hospital from 1980 until 2003, and is a clinical associate professor in the Department of Surgery at Monash University.
Associate Professor Geoff Littlejohn
Associate Professor Littlejohn is Professor of Medicine and Director of Rheumatology at Monash Medical Centre, Melbourne, and Adjunct Professor at Edith Cowan University, Perth. He completed a MD thesis in Toronto on Diffuse Idiopathic Skeletal Hyperostosis and has remained an international expert in that field. He has also published widely in other rheumatic disorders including inflammatory joint disease, chronic pain syndromes, and osteoarthritis.
THE LEGISLATION
The legislative scheme for the making of Statements of Principles is set out in Parts XIA and XIB of the VEA. Statements of Principles operate as templates, which are ultimately applied by decision-makers in determining individual claims for benefits under the VEA and the Military Rehabilitation and Compensation Act 2004 (the MRCA).
Fundamental to Statements of Principles is the concept of sound medical-scientific evidence, which is defined in section 5AB(2) of the VEA. Information about a particular kind of injury, disease or death is taken to be sound medical-scientific evidence if:
a) the information
is consistent with material relating to medical science that has been published in a medical or scientific publication and has been, in the opinion of the RMA, subjected to a peer review process; or
in accordance with generally accepted medical practice, would serve as the basis for the diagnosis and management of a medical condition; and
in the case of information about how that injury, disease, or death may be caused - meets the Applicable criteria for assessing causation currently applied in the field of epidemiology.
The functions of the Council are set out in section 196W of the VEA. In this case, the Council was asked (under section 196Y of the VEA) first by a person eligible to make a claim for a pension and secondly by an eligible organisation mentioned in s196Y of the VEA, to review the contents of:
Statement of Principles concerning lumbar spondylosis No. 37 of 2005 as amended by Statements of Principles No. 78 of 2008 and No. 36 of 2010, being a Statement of Principles determined by the RMA under section 196B(2) of the VEA (the reasonable hypothesis test) and
Statement of Principles concerning lumbar spondylosis No. 38 of 2005 as amended by Statements of Principles No. 79 of 2008 and No. 37 of 2010, being a Statement of Principles determined by the RMA under section 196B(3) of the VEA (the balance of probabilities test).
Specifically, the first Applicant contended that there was sound medical-scientific evidence on which the RMA could have relied to include repetitive or persistent flexion, extension or twisting of the lumbar spine as a factor or factors in Statements of Principles concerning lumbar spondylosis Nos. 37 & 38 of 2005. The second Applicant contended that there was sound medical-scientific evidence, on which the RMA could have relied to provide a lower exposure threshold for helicopter crews in Statements of Principles concerning lumbar spondylosis Nos. 37 & 38 of 2005 as amended by Statements of Principles Nos. 78 & 79 of 2008 and 36 & 37 of 2010.
In conducting its review, the Council must review all the information that was available to (before) the RMA at the time it determined, amended, or last amended the Statements of Principles (the relevant times) and is constrained to conduct its review by reference to that information only.
Under section 196W of the VEA, the Council can only reach the view that a Statement of Principles should be amended on the basis of sound medical-scientific evidence.
BACKGROUND
First Application for review by the Council
On 8 November 2005, the RMA under subsections 196B(2) and (3) of the VEA revoked Instruments Nos. 46 & 47 of 2002 as amended by Instruments Nos. 77 & 78 of 2002 and determined in their place Statements of Principles concerning lumbar spondylosis Nos. 37 & 38 of 2005. The Statements of Principles took effect from 16 November 2005.
On 11 November 2005 the Statements of Principles were registered on the Federal Register of Legislative Instruments.
On 16 February 2006 in accordance with section 42 of the Legislative Instruments Act 2003 the Statements of Principles were tabled in the House of Representatives and in the Senate.
An Application for Review of Statements of Principles Nos. 37 & 38 of 2005 was received by the Council on 17 January 2006 (the first Application). The Application contended that the Statements of Principles should include a factor or factors concerning repetitive or persistent flexion, extension or twisting of the lumbar spine.
Pursuant to section 196ZB of the VEA the Council published, in the Gazette No. 23 of 14 June 2006, a Notice of its Intention to Carry Out a Review under section 196W of the Act of all of the information available to the RMA when it determined, amended or last amended the Statements of Principles concerning lumbar spondylosis and invited eligible persons or organisations authorised so to do to make submissions to the Council. The Council gazetted subsequent notices as to the dates by which written submissions must be received by the Council.
The information sent by the RMA to the Council - First Application
By letter dated 27 April 2006 the RMA, under section 196K of the VEA, sent to the Council the information the RMA advised was available to (before) it at the relevant times, as listed in Appendix B.
By agreement between the RMA and the Council, information the RMA advised was available to (before) it at the relevant times is posted on a secure website (referred to as FILEForce). It was made accessible by the Council to the Repatriation Commission and the Military Rehabilitation and Compensation Commission (the Commissions), the first Applicant and other participants in the review via confidential password. The information which was available to (before) the RMA at the relevant times was posted on FILEForce on 29 March 2009.
Amendments to Statements of Principles
By Notice of Investigation under s196G of the VEA dated 19 June 2008, the RMA gave notice of its intention to carry out an investigation in respect of aircraft flight as a factor in lumbar spondylosis, to be carried out in the context of Statements of Principles concerning lumbar spondylosis Nos 37 and 38 of 2005. The RMA invited eligible persons or organisations authorised so to do to make submissions in writing.
On 22 October 2008, the RMA under subsections 196B (2) and (3) of the VEA determined amending Statements of Principles Nos. 78 & 79 of 2008, concerning lumbar spondylosis. The amending Statements of Principles took effect from 5 November 2008.
No Applications were received by the Council in respect of the 2008 amendments.
By Notice of investigation under s196G of the VEA dated 17 April 2009, the RMA gave notice of its intention to carry out an investigation in respect of aircraft flight as a factor in lumbar spondylosis in the context of Statements of Principles concerning lumbar spondylosis Nos 37 & 38 of 2005, as amended by Instrument Nos. 78 & 79 of 2008. The RMA invited eligible persons or organisations authorised so to do to make submissions in writing. On 22 April 2010, the RMA under subsections 196B (2) and (3) of the VEA determined amending Statements of Principles concerning lumbar spondylosis Nos. 36 & 37 of 2010. The amending Statements of Principles took effect from 3 May 2010.
On 3 May 2010 the Statements of Principles were registered on the Federal Register of Legislative Instruments.
On 11 May 2010 in accordance with section 42 of the Legislative Instruments Act 2003 the Statements of Principles were tabled in the House of Representatives and in the Senate.
Second Application for review by the Council
An Application for Review of Statements of Principles concerning lumbar spondylosis Nos. 37 & 38 of 2005 as amended by Statements of Principles Nos. 78 & 79 of 2008, and 36 & 37 of 2010 was received by the Council on 29 June 2010 (the second Application). The second Application contended that the Statements of Principles should be amended to provide lower exposure thresholds for helicopter crews.
The second Applicant contended that helicopter crews are subject to greater vibration and less adjustable seating than powered aircraft crews and had more limited opportunity for movement in flight.
Pursuant to section 196ZB of the VEA the Council published, in the Gazette No. 2, 20 January 2010, a Notice of its Intention to Carry Out a Review under section 196W of the Act of all the information available to the RMA when it determined, amended or last amended the Statements of Principles concerning lumbar spondylosis and invited eligible persons or organisations authorised so to do to make submissions to the Council. The Council gazetted subsequent notices as to the dates by which written submissions must be received by the Council.
The information sent by the RMA to the Council - Second Application
By letter dated 13 May 2011 the RMA, under section 196K of the VEA, sent to the Council the information the RMA advised was available to (before) it at the relevant times, as listed in Appendix B.
The information which was available to (before) the RMA at the relevant times was posted on FILEForce on 24 May 2011 in accordance with the arrangements detailed in paragraph [ REF _Ref348967296 \r \h \* MERGEFORMAT 19] above and made accessible to the Commissions, the Applicants and other participants in the review via confidential password.
Second Applicant's Position
The second Applicant advised the Council by electronic mail of 22 July 2011 that
there was concern amongst aviation medicine practitioners and other ADF health personnel that there was a discrepancy between the treatment of fixed wing and helicopter aircrew in the RMA Statements of Principles relating to back problems
While initially the above concern was reinforced, I [am] satisfied that no such discrepancy existed, at least in relation to lumbar spondylosis. This would certainly be supported by the evidence base available to the RMA.
no change is required at this time.
no submission will be provided.
The Council took account of the second Applicant's position in making the preliminary decision on the proposed scope of review.
Notification of Preliminary Decisions on Proposed Scope of Review and Proposed Pool of Information
In separate letters, dated 20 October 2011, to each of the first Applicant, the second Applicant and the Commissions, the Council in summary:
advised of the Councils preliminary decisions on the proposed scope of the review and proposed pool of information;
invited the Applicants and Commissions to make any written comments as to the Council's preliminary decisions by close of business on 17 November 2011; and
advised that if any written comments were made, any complementary oral comments could be made at a hearing of oral submissions complementing the written submissions.
No comments were received.
The Council held a meeting on 20 February 2012 to consider all the written submissions and complementary oral submissions.
Proposed Scope of Review
The Councils preliminary decision on the scope of the review, as advised to the Applicants and the Commissions on 25 October 2011, was as follows:
Without limiting the scope of the Councils review of (some or the whole of) the contents of the Statements of Principles, the Council presently proposes to have particular regard to whether there was sound medical-scientific evidence upon which the RMA could have relied to amend either or both of the Statements of Principles in any or all of the following ways:
a) the possible inclusion of a factor or factors in respect of:
repetitive or persistent flexion, extension or twisting of the lumbar spine.
b) and, the possible excision or amendment of the factors:
(1) referred to at paragraphs (ja) and (sa) of Statement of Principles No. 37 of 2005, as amended by Statements of Principles Nos 78 of 2008 and 36 of 2010:
(ja) flying in a powered aircraft as operational aircrew, for a cumulative total of at least 2500 hours within the ten years before the clinical onset of lumbar spondylosis;
and
(sa) flying in a powered aircraft as operational aircrew for a cumulative total of at least 2500 hours within the ten years before the clinical worsening of lumbar spondylosis;
(2) referred to at paragraphs (ia), (iaa), (ra) and (raa) of Statement of Principles No. 38 of 2005 as amended by Statements of Principles Nos. 79 of 2008 and 37 of 2010:
(ia) flying a powered aircraft for a cumulative total of at least 5000 hours within the ten years before the clinical onset of lumbar spondylosis; or
(iaa) flying in a helicopter as operational aircrew, for a cumulative total of at least 5000 hours within the ten years before the clinical onset of lumbar spondylosis:
(ra) flying a powered aircraft for a cumulative total of at least 5000 hours within the ten years before the clinical worsening of lumbar spondylosis; or
(raa) flying in a helicopter as operational aircrew, for a cumulative total of at least 5000 hours within the ten years before the clinical worsening of lumbar spondylosis:
Proposed Pool of Information
As mentioned above, the RMA is obliged under section 196K of the VEA to send to the Council all the information that was available to it (the RMA) at the relevant times. That comprises all the information that was available to the RMA when it determined, in 1995, the original Statements of Principles concerning lumbar spondylosis and all the information subsequently available at all times when the Statements of Principles were amended, or revoked and replaced, up to and including the information that was available in 2010 when the RMA determined the amending Statements of Principles Nos. 36 & 37 of 2010. In other words, within 28 days after being notified that the Council has been asked to conduct a review, the RMA must send to the Council all the information in respect of lumbar spondylosis which was in the possession of the RMA at the time it (the RMA) made the decision that triggered the Council's review.
The chronology of the RMA sending the information to the Council is detailed in [ REF _Ref348967802 \r \h \* MERGEFORMAT 18], [ REF _Ref348967296 \r \h \* MERGEFORMAT 19], [ REF _Ref348967810 \r \h \* MERGEFORMAT 29] and [ REF _Ref348967812 \r \h \* MERGEFORMAT 30] above. As mentioned above, all the information which was available to the RMA at the relevant times was made available to the Applicants and the Commissions for the purposes of the review.
In determining its preliminary view on the proposed pool of information the Council applied the methodology it had advised the Applicants and Commissions on 25 October 2011 i.e. that the pool of information should comprise the information:
that was available to (before) the RMA at the relevant times;
which was sent by the RMA to the Council under section 196K of the VEA;
which was considered by the Council to be sound medical-scientific evidence as defined in section 5AB(2) of the VEA being information which:
epidemiologists would consider appropriate to take into account; and
in the Council's view 'touches on' (is relevant to) the contended factor/s; and
which has been evaluated by the Council according to epidemiological criteria, including the Bradford Hill criteria.
Information which the RMA advised was not available to (not before) the RMA at the relevant times, was not taken into account by the Council for the purposes of the review, as it could only be considered as 'new information.
A copy of the Council's preliminary list of the proposed pool of information was forwarded to the Applicants and the Commissions on 24 October 2011.
FIRST APPLICANTS SUBMISSIONS and comments on the Proposed Scope of the Review and Proposed Pool of Information decisions
The first Applicant made two written submissions to the RMA and to the Council, which were taken into account by the Council.
In his Application to the Council of 28 February 2006, the first Applicant stated that his grounds for review were the absence of reasons by the RMA for the deletion of factors included in the 2002 Statements of Principles concerning 'twisting and turning' from the 2005 Statements of Principles:
The removal of this subsection factor, ie. Twisting and Turning for the acceptance of lumbar spondylosis is detrimental to the
.care and welfare of the many injured veterans
. I have not seen any reason for its removal
A further written submission by the first Applicant dated 19 August 2011 was received by the Council on or about 19 August 2011. In it the first Applicant submitted that the processes whereby the RMA had determined a factor in 2002 for repetitive or persistent flexion, extension or twisting of the lumbar spine, and had subsequently removed it in 2005 were doubtful:
I submit that none of the RMA members have every (sic) served on a ship at sea whether in fine or stormy conditions so they would have supposedly carried out a full investigation of the factor originally when it was first included in 2003, it smacks of Political Cost savings when a factor goes through the initial process to be included then suddenly in two years it is withdrawn with out any consultation.
Does that mean the members of the original RMA board who inserted the original factor
did not carry out their due process properly in the first case.
As mentioned above, the first Applicant also made an oral submission complementing his written submission.
In his oral submission complementing his written submissions, the first Applicant contended there was no justification for removal in 2005 of the factor that had been included in the Statements of Principles in 2002:
Im taking they were doing their job at the time and no one is saying they werent, so why, after that factor was included into the balance of probabilities and the reasonable hypothesis, why was it three years later, in 2004, suddenly there was another review and that factor was deleted after all the sound medical advice and revision was used to include it in the first place?
there was no justification to take it out when they had already considered it and said there was enough sound medical and scientific knowledge to have it included in the first place.
The first Applicant referred the Council to a paper by Andrea Radebold MD dated 28 February 2010, about which he said:
lateral bending with flexion and extension and axial rotation with lateral bending will cause lumbar spondylosis.
The first Applicant submitted that the literature cited by the Commissions in their written submissions did not address the experiences of military personnel, and that there is:
nothing in all the
studies that are quoted in these papers - mining, etcetera, lumberjacks ...that have anything whatsoever to do with a military way of life.
The first Applicant claimed that his experiences and those of his colleagues in the Australian Navy are relevant to the question.
Now, youre on a ship at sea. That ship is twisting; its rocking in a way that its going up and down.
We run up and down decks and ladders 24 hours a day, seven days a week and we
. vibrate in our bodies 24/7 the whole time were on a ship
twisting and turning
running up and down ladders
The first Applicant clarified to the Council in the course of the oral hearing that his contention was that twisting and turning alone, without an association with prolonged bending forward and lifting, should be included as a factor in the Statements of Principles but went on to contend the factor, as it stood in 2002, should be included.
The first Applicant made no written submission in respect of flight factors but at the oral hearing he submitted that the flight factors which were contained in the revoked 2002 Statements of Principles concerning lumbar spondylosis should be reinstated. His contention was that the factors in Statements of Principles Nos. 46 and 47 of 2002 were more generous to service personnel than the factors which presently apply and must have had some medical scientific basis which should now prevail. The first Applicant declined to indicate any evidence in support of that contention.
The first Applicant made no written or oral comment on proposed scope of the review and proposed pool of information decisions.
second Applicant's submissions and comments on the Proposed Scope of the Review and Proposed Pool of Information decisions
Consistently with the position mentioned at [ REF _AGSRef70554751 \w \h \* MERGEFORMAT 31] above, the second Applicant made no written (and consequentially no complementary oral) submission.
COMMISSIONS SUBMISSIONS and comments on the Proposed Scope of the Review and Proposed Pool of Information decisions
Two submissions were made by the Repatriation Commission to the Council for review. The submissions were also made on behalf of the Military Rehabilitation and Compensation Commission.
The first written submission dated March 2010 was made in respect of flexion, extension, twisting of the spine. The Commissions submitted that the available sound medical scientific evidence on heavy physical activity is adequately reflected in the existing factors for carrying and lifting and did not support the inclusion of an additional factor for 'flexion, extension, twisting of the spine'.
A second submission in respect to the aircraft flight factors was made in July 2011. The Commissions submitted there is no sound medical scientific evidence that was available to the RMA to depart from the RMA's conclusions as reflected in the current Statements of Principles.
A Medical Officer with the Department of Veterans Affairs, representing the Commissions, made an oral submission complementing the Commissions written submission at the Councils meeting on 20 February 2012. This officer was the principal author of the two written submissions.
Commissions submissions on 'flexion, extension, twisting of the spine'
In their first written submission the Commissions addressed the reinstatement of the factors that were in Statements of Principles No. 46 and 47 of 2002 and which were omitted from Statements of Principles No. 37 and 38 of 2005, that concerned:
repetitive or persistent flexion, extension or twisting of the lumbar spine for at least one hour each day on more days than not for at least 10 years
that the Commissions submitted, without reference to heavy physical activity, could have been met by someone undertaking normal activities of every day living.
The Commissions outlined the history of manual activity factors in Statements of Principles concerning lumbar spondylosis and noted that in earlier versions of these instruments, there were factors dealing with twisting of the spine and with lifting and carrying loads, which were later removed or modified.
In the Commissions submission:
the evidence that was available to the RMA establishes that it is more probable than not that lumbar spondylosis can be caused by heavy physical activity
The Commissions stated approach was to address 'flexion, extension, twisting of the lumbar spine', and to look more generally at evidence of the potential association between the role of physical activity and lumbar spondylosis.
The Commissions specifically excluded 'areas such as acute injury, vehicle driving and whole body vibration' from their submissions and focussed on the evidence for specific types and quantities of physical activity and how, in the Commissions submissions, the factors for these activities should be constructed to best reflect the sound medical scientific evidence.
The Commissions submitted that the quality of available evidence was not high, and that most of the relevant studies were cross-sectional studies of lumbar spine disorders.
In his oral submission, the Commissions representative submitted that given the shortage of medical-scientific evidence before the RMA about lumbar spondylosis, further investigation of the types of activities undertaken by the Applicant could be warranted.
The Commissions concurred with the Councils preliminary decision on the proposed pool of information.
The Commissions made submissions on 13 occupational studies, four athlete studies and five general population studies from the information that was available to the RMA at the relevant times.
Of the occupational studies, the Commissions cited:
Seidler et al 2001 in respect of which the Commissions submitted that it is a study:
providing the best available evidence. It is the only analytical study. It has the best exposure information, allowing for a dose-response assessment. It has the best information on specific types of activities. However, it is not without shortcomings. There is potential for selection and recall bias. Most notably, odds ratios always overestimate relative risk when the odds ratio is above one. The more prevalent the disease and the higher the odds ratio, the greater the overestimate. For a highly prevalent disease such as lumbar spondylosis, the high reported odds ratios in the Seidler et al study provide a significant overestimate of the risk from heavy physical activity.
The Commissions submitted that the study:
investigated the relationship between degenerative change in the lumbar spine and cumulative occupational exposure to lifting and carrying and to working postures with extreme forward bending.
and found:
a positive association between cumulative exposure to lifting/carrying and risk of symptomatic lumbar spine degeneration, with a significant dose response trend (p < 0.0005) and a statistically significant odds ratio of 8.5 for the highest exposure category (> 150,000 kg2 x hours). Working for 10 years or more in an occupation with a high physical workload was also a significant risk factor (OR 6.5, 95% CI 2.7 to 16.1 vs. low physical workload).
and that:
Cumulative hours spent working in a posture involving > 90º of trunk flexion was also associated with an increased risk of symptomatic lumbar spine degeneration
.
The Commissions noted further that the study found:
The odds ratio for > 1500 hrs working in that posture was 3.5 (95% CI, 1.5 - 7.9). This odds ratio was adjusted for the effects of lifting and carrying. The majority of cases in the highest category for hours of extreme forward bending were also in the highest category for cumulative lifting and carrying (29 of 34).
Brinckmann et al 1998 in respect of which the Commissions submitted the study:
compared the lateral lumbar spine X-rays of 355 male subjects from five cohorts with long-term heavy occupational loading of the lumbar spine with those from 737 male subjects who had undergone X-ray for pre-employment medicals, minor back complaints or complaints unrelated to the lumbar spine.
The Commissions noted that:
Frequent lifting and handling of objects weighing 50 kg or more and/or the handling of heavy objects in confined spaces or over uneven ground was associated with significant decreases in disc height in the lumbar spine. Disc height changes were most marked in the underground miners but not significantly different from the controls
Lawrence & Aitken-Swan 1953 in which, the Commissions submitted, the authors found:
a higher prevalence of low back pain and clinically diagnosed disc disorders in underground coal miners than in non-miners.
Kellgren & Lawrence 1952 in which the Commissions submitted the authors:
further investigated a subset of the miners from the above survey (Lawrence & Aitken-Swan (1953)), carrying out a more detailed clinical and radiological study in males aged 40 to 50 years. Moderate to severe radiological lumbar disc degeneration was significantly more prevalent and widespread in underground coal miners than in manual (engineering yard) workers or office workers. There was a clear association between degenerative change on X-ray and lumbar-sciatic pain. However, only half the subjects with moderate or severe radiological degenerative changes had such pain.
Lawrence 1955 in which the Commissions submitted that the authors:
sought to explain the findings from the above surveys of miners (Kellgren & Lawrence (1952)), by further investigating risk factors associated with underground mining, including heavy lifting and posture.
An assessment based on headroom at different coalfaces and the need for working in a stooping or kneeling position found that work posture had a possible influence (not reaching statistical significance) but was less important than injury or duration of lifting.
Kellgren and Lawrence 1958 which the Commissions submitted found:
a higher prevalence of moderate or severe lumbar disc degeneration
in coal miners (79%) than in (male) cotton mill workers (65%) or other miscellaneous workers (55%). The same pattern was seen for lumbar apophyseal joint osteoarthritis (41% v 24% v 21%)
Lawrence et al 1966, which the Commissions submitted found that:
radiological lumbar disc degeneration was more prevalent in foundry workers (with at least 10 yrs work) than in an age-matched general population sample. However, apophyseal joint arthritis in the lumbar spine was significantly more prevalent in the controls.
Hult 1954, which the Commissions submitted was a large scale survey in Sweden of neck and back problems in selected workers (aged 25 to 59) which demonstrated that:
Radiological degenerative changes in the lumbar spine were more prevalent in the heavy workers
The difference in the extent of pronounced degenerative change between heavy and light workers was particularly evident in subjects aged 45 and older. More than 90% of all subjects aged 55 to 59 had some radiological signs of lumbar disc degeneration.
Caplan et al 1966, that the Commissions submitted:
assessed radiological degenerative change in the lumbar spines of coal miners aged 40 years and over in Pennsylvania...
and found that:
duration of heavy work was associated with the presence of osteophytes in older subjects (55 to 64). Prior history of back injury was associated with both disc narrowing and osteophytes (results unadjusted for age).
Sairanen et al 1981, which the Commissions submitted found:
no association
between length of work as a lumberjack and prevalence of lumbar disc degeneration. A history of low back pain was reported by half the subjects with normal radiographic findings and two-thirds of those with degenerative changes.
Katevuo et al 1985 that the Commissions submitted:
.compared spine X-rays in 30 to 59 year old Finnish dentists and farmers, finding more lumbar disc and apophyseal joint degeneration in the farmers, particularly those 49 years and under.
White et al 1993, that the Commissions submitted:
found a higher prevalence of radiological degeneration in the lumbar spine in female middle-aged physical education teachers in England than in age- and sex-matched general population controls (p < 0.001). However, the control subjects reported more low back pain.
Luoma et al 1998 that the Commissions submitted:
compared lumbar spine MRI findings in machine drivers, carpenters and office workers aged 40 to 45 years in Finland. Degenerative changes were significantly associated with a history of back injury, but not with heavier occupational physical activity.
Evans et al 1989 that the Commissions submitted:
compared lumbar MRI findings in ambulatory and sedentary workers (meter readers and customer service representatives in Colorado), finding no difference in the prevalence of disc degeneration in the males but a significantly higher prevalence of disc degeneration in the sedentary females.
Of the studies in athletes the Commissions cited:
Videman et al 1995 about which the Commissions submitted:
The athletes had less recent back pain than the controls. Weight lifters had more lumbar degenerative changes than other athletes. There was no difference in the extent of degenerative change between runners and shooters, but soccer players had greater lower lumbar degeneration. After controlling for age and occupational loading, elite level weight lifting (over more than 20 years) could explain only about 10% of the disc degeneration that was seen in that group.
Lundin et al 2001 that the Commissions submitted:
found that former elite athletes (27-39 yrs) from a range of sports had no more back pain than control subjects. They did not report on the extent of degenerative change by type of activity.
Sward et al 1991 that the Commissions submitted:
.found considerably more disc degeneration in the thoracolumbar spines of Swedish male national gymnasts vs non-athletes (75% vs 31%).
Healy et al 1996 that the Commissions submitted:
observed significant lumbar degenerative changes in MRI findings of 16 of 19 male athletes, none of whom reported symptoms. The study used no control group but reported that the prevalence of degenerative change was 'similar to that seen in other populations'.
Of the other studies, the Commissions submitted:
Battie et al 1995 as finding:
heavier lifetime occupational and leisure physical loading was associated with greater disc degeneration in the upper lumbar levels.
Biering-Sorensen et al 1985 as being:
A Danish population study of 60 year olds (which) found current heavy physical labour to be associated with X-ray observed lumbar disc degeneration.
ONeill et al 1999 as:
Heavy physical activity was also associated with lumbar osteophytosis but in men only, in a UK population sample, reported by ONeill et al (1999).
Videman et al 1990:
In an autopsy study Videman et al (1990) found an association between vertebral osteophytosis and heavy work; whereas symmetrical disc degeneration was related to sedentary work.
The spinal pathology was seen least in subjects with moderate or mixed physical loading
Julkunen et al 1981 as finding:
that antero-posterior X-rays of a large general population sample demonstrated a positive association of both prevalence and 6-year incidence of thoracic spondylosis with 'arduousness of work' examined in categories.
The Commissions concluded by submitting that collectively, the studies available to the RMA were methodologically weak and are only able to demonstrate associations, not properly test for causation. Only the Seidler case-control study addressed the particular disease as defined by the current Statements of Principles.
The Commissions submitted that the cited studies showed only a moderate degree of correlation between the extent of degenerative changes on imaging and the presence and severity of clinical signs. Degenerative changes are strongly associated with age and most of the studies inadequately controlled for the role of age.
The Commissions also submitted that there was a lack of control for other potential founders; crude exposure assessment potential biases in selection, classification and recall. Although confounding by discrete injury may be a problem, there is some evidence, particularly from the Lawrence study, that the effect of heavy physical activity is independent from discrete injury.
In the Commissions submission, the Seidler case-control study presented the best available evidence. Its methods of exposure allowed for a dose-response assessment.
However, the Commissions also submitted that there were shortcomings in this type of study, which the Commissions contended has the potential for recall and selection bias, with the consequence that the odds ratio in the Seidler et al study would be an overestimation of the risk from heavy physical activity, because odds ratios are overestimates when the disease is highly prevalent, resulting in a significant over-estimate of the risk from heavy physical activity.
The Commissions submitted that despite the limitations, the cross-sectional studies provided support for the Seidler et al study, and overall it is more probable than not that lumbar spondylosis can be caused by long-term heavy physical activity. Carrying or lifting heavy loads is, in the Commissions submission, the component of heavy physical activity that is most consistent with the evidence and quantifiable.
In regard to the position of the spine, the Commissions contended that the available evidence lends support to the notion that heavy physical work in awkward postures may increase the risk of lumbar spondylosis. The Commissions referred in particular to the Seidler study, which mentions 'extreme forward bending', and the Brinckmann and Lawrence papers concerning working with low head heights and submitted
undertaking heavy physical work in awkward posture could over-burden the spine by increasing or redirecting the biomechanical load on the spine.
The Commissions submitted that this association appears less strong than that for lifting and carrying.
The Commissions opposed a return to earlier versions of the factor, pointing out that the 2002 version of the Instruments (46 and 47) did not distinguish between the flexion, extension and twisting required in heavy lifting, and that which might occur in normal daily activities.
In the Commissions' view, the available evidence does not support the contention that flexion, extension or twisting per se adds to the risk of developing lumbar spondylosis. These are normal activities of the spine.
The Commissions also expressed doubt about the need for an additional Statement of Principles for heavy physical activity carried out in awkward postures.
In an oral submission complementing the Commissions written submission, the Commissions representative said that:
... in 1999 the
repetitive or persistent flexion/extension [factor] was put into the Statements of Principles in the context of undertaking physical activity.
but that in 2002, the Statements of Principles were amended to include:
a stand-alone lifting and carrying factor and a separate repetitive or persistent flexion, extension or twisting factor ...without any connection to undertaking physical activity.
He submitted that in the Commissions' view, the factor in the earlier 1999 Statements of Principles,
was more reflective of the evidence than the 2002 version (and)
there is good evidence for heavy lifting and carrying
not so good evidence (for)
sustained forward bending
and that while there may be a case for reintroducing an additional factor for sustained forward bending, this would be:
another parameter of heavy physical activity, because it is in that context that weve got the evidence.
He said that the Commissions did not support a stand alone bending and twisting type factor:
without the concomitant heavy physical activity.
Commissions submissions on flight factors
A further written submission by the Commissions was made in relation to the second Application for review and concerning powered aircraft and helicopter flight factors in Statements of Principles No 36 and 37 of 2010. This submission complemented the Commissions previous submission which related to flexion, extension and twisting of the spine. The second submission focussed on:
flying powered aircraft;
flying in a powered aircraft as operational aircrew; and
flying in a helicopter as operational aircrew
The Commissions concluded their written submission:
On the information available, the Commissions see no evidence, apart from the Applicants contention itself, to depart from the RMAs conclusions as reflected in the current Statements of Principles.
Revised proposed Scope of Review and Revised proposed Pool of information
After the oral hearing the Council revised its preliminary decision on the scope of the review in respect of flight factors.
As noted above [ REF _Ref349134042 \r \h \* MERGEFORMAT 26], the second Applicant sought review of Statements of Principles concerning lumbar spondylosis Nos. 37 & 38 of 2005 as amended by Nos. 78 & 79 of 2008, and Nos. 36 & 37 of 2010. The Amendment Statements of Principles Nos. 78 & 79 of 2008 and Nos. 36 & 37 of 2010 concerned factors (ja), (ia), (iaa), (ra), (raa) and (sa) of Statement of Principles No. 37 of 2005, which all concern flying in aircraft or helicopters (flight factors).
The second Application contended that the Statements of Principles should be amended to provide lower exposure thresholds for helicopter crews, however that contention was withdrawn by the second Applicant who subsequently informed the Council that the accuracy of the current Statements of Principles in respect of the flight factors was accepted. The Commissions contended for no change to the flight factors.
The first Applicant made no written submission in respect of the flight factors. At the oral hearing however, he did make the submission noted above [ REF _Ref346185263 \r \h \* MERGEFORMAT 51].
Section 196ZA (3) of the VEA entitles interested persons to make an oral submission complementing the written submission. The first Applicant made written submissions only in respect of repetitive or persistent flexion, extension or twisting of the lumbar spine and not in respect of the flight factors. The Council has taken the first Applicant's written and oral submissions on repetitive or persistent flexion, extension or twisting of the lumbar spine into account in reaching its decision.
The Council tentatively decided that, as neither the second Applicant nor the Commissions contended for any change to the flight factors, it would not include those factors in the scope of the review. The Council tentatively decided that the scope of the review identified on a preliminary basis (see [ REF _Ref344902969 \r \h \* MERGEFORMAT 36]) in respect of repetitive or persistent flexion, extension or twisting of the lumbar spine should comprise the review, that is:
Without limiting the scope of the Councils review of (some or the whole of) the contents of the Statements of Principles, the Council presently proposes to have particular regard to whether there was sound medical-scientific evidence upon which the RMA could have relied to amend either or both of the Statements of Principles in any or all of the following ways:
a) the possible inclusion of a factor or factors in respect of:
repetitive or persistent flexion, extension or twisting of the lumbar spine.
By letter dated 16 January 2013, the Council informed the first Applicant, the second Applicant and the Commissions of the Council's revised proposed scope of the review and revised proposed pool of information and invited them to make any written comments as to the Council's revised view on scope and pool by close of business on 8 February 2013.
The only comments received were from the first Applicant who reminded the Council of his oral comments. The Council noted his comments and, as noted above, that the first Applicant's oral submission on the flight factors did not complement his written submission and most importantly, identified no medical science to support any change to the flight factors in the Statements of Principles.
Final Scope of Review
The Council's final view on the scope of the review, having taken account of the first Applicant's comments was that it should comprise only the issue noted at [ REF _Ref346185263 \r \h \* MERGEFORMAT 51& REF _Ref349134736 \r \h \* MERGEFORMAT 88] above.
Final Pool of Information
The Council's final decision on the pool of information was that it should comprise the sound medical-scientific evidence it had identified on a revised preliminary basis as listed in Appendix A.
In reaching this decision, the Council took into account the written submissions and complementary oral submissions and considered whether any of the information, to which it was referred, could or should be in the pool.
As mentioned above, the Council noted the first Applicant's references to and submissions concerning information which was not available to (not before) the RMA (see Appendix C). As mentioned above, the Council in its review was unable to (and so did not) consider information which was not available to (not before) the RMA at the relevant times.
REASONS FOR THE COUNCILS DECISION
The Councils Task
In conducting a review the Council follows a two-step process. As its first step, the Council identified the pool of sound medical scientific information. The Council identified, from all the information that the RMA sent to the Council, the sound medical-scientific evidence which in its view is relevant to the issue of whether repetitive or persistent flexion, extension or twisting of the lumbar spine could provide a relevant connection between lumbar spondylosis and service.
The second step required the Council to determine whether:
there is sound medical-scientific evidence in the pool that indicates ('points to' as opposed to merely 'leaves open') whether exposure to repetitive or persistent flexion, extension or twisting of the lumbar spine (if found to exist in a particular case) could provide a link or element in a reasonable hypothesis connecting lumbar spondylosis to relevant service. The Council had to find that the hypothesis contended for was reasonable and not one which was obviously fanciful, impossible, incredible or not tenable or too remote or too tenuous.
on the sound medical-scientific evidence in the pool, exposure to repetitive or persistent flexion, extension or twisting of the lumbar spine (if found to exist in a particular case) could provide a relevant connection between lumbar spondylosis and relevant service according to a standard of satisfaction on the balance of probabilities, or as being more probable than not.
In these Reasons the association for both the reasonable hypothesis test (at REF _Ref344967798 \r \h \* MERGEFORMAT 99.1] and the balance of probabilities test at [ REF _Ref344967813 \r \h \* MERGEFORMAT 99.2]) are respectively referred to as the relevant association.
It was with these tests firmly at the forefront of its collective mind that the Council considered the sound medical-scientific evidence in the pool of information and the submissions made by the first Applicant and the Commissions referable to the matters within the scope of review.
In forming its judgement on whether there is sound medical-scientific evidence that indicates (ie 'points to' as opposed to merely 'leaving open') the relevant association, the Council was conscious that the reasonable hypothesis test is a test of possibility and an unusually light burden. If the reasonable hypothesis test was found not to be satisfied, the balance of probabilities test necessarily could not be met.
DOES THE SOUND MEDICAL - SCIENTIFIC EVIDENCE, 'POINT TO' OR 'LEAVE OPEN' THE RELEVANT ASSOCIATION?
As mentioned above, having settled the pool of information, the second question for the Council to consider was whether the sound medical-scientific evidence in the pool of information 'points to' a contended factor in the scope of the review as a link or element in a reasonable hypothesis connecting lumbar spondylosis to relevant service (see para [ REF _Ref344902875 \r \h \* MERGEFORMAT 9] and footnotes), and if so, whether the relevant association exists on the balance of probabilities (see para [ REF _Ref344902875 \r \h \* MERGEFORMAT 9] and footnotes).
The only basis upon which the Council can review the contents of a Statement of Principles is by reviewing all the information that was available to (before) the RMA at the relevant times, in order to ascertain whether there was sound medical-scientific evidence upon which the RMA could have relied to amend either or both of the Statements of Principles.
The Council considered all the articles in the pool. However, the Council in these Reasons focused its discussion upon its analysis of those articles in the pool which it considered most pertinent to the scope of review.
Ultimately, matters of weight are questions for the Council in the exercise of its expertise and scientific judgement, noting that the Councillors are appointed to a particular review because of their specialist expertise in the particular condition (in this case lumbar spondylosis) and the matters within the scope of the review.
THE COUNCIL'S ANALYSIS OF THE INFORMATION BEFORE THE RMA
Preliminary comment on lumbar spondylosis
Set out below are some general and introductory comments on lumbar spondylosis and the Council's analysis of the information in the pool.
Lumbar spondylosis is defined in the current Statements of Principles as:
degenerative changes affecting the lumbar vertebrae or intervertebral discs, causing local pain and stiffness or symptoms and signs of lumbar cord, cauda equina or lumbosacral nerve root compression, but excludes diffuse idiopathic skeletal hyperostosis and Scheuermanns kyphosis.
Lumbar spondylosis attracts ICD-10-AM codes M47.16, M47.17, M47.26, M47.27, M47.86, M47.87, M47.96, M47.97 or M51.3.
General observations
Lumbar spondylosis is a very common condition which typically affects individuals over the age of 60 years.
The Review Council for the review of Statements of Principles for Cervical Spondylosis Nos. 33 & 34 of 2005 (SMRC Declaration No. 15) included comments in its decision about the condition that this Council considers to be analogous to lumbar spondylosis:
The Review Council recognise
spondylosis as a clinical diagnosis. It is a common disorder of poorly understood aetiology. Clinically, patients present with symptoms or signs, the causes of which are often difficult to determine.
The contribution of external factors to the development of
spondylosis is difficult to investigate or verify. Degenerative changes
are common and are often asymptomatic. The correlation between the radiological assessment of degeneration, with changes in structure or function, and signs or symptoms experienced by the patient is generally accepted to be loose, but where investigative imaging reveals a close relationship between them, a diagnosis of
spondylosis can be made.
It is difficult to document the postulated causal pathway
to degenerative change affecting the intervertebral discs or other structures of the spine, by clinical symptoms or signs, or by imaging. These difficulties are reflected in gaps in the evidence that appear in the academic literature.
Scientific research into the pathology of the condition has predominantly focused on the objective evidence of degeneration in the spine (without the symptoms or signs which would meet the description cervical spondylosis provided by the Statements of Principles) in the context of lengthy occupational exposures to various stresses with frequently inadequately documented related clinical findings. The major scientific challenge confronting this Council is to apply their collective expertise to interpret this apparently scant and patchy medical scientific evidence.
Similarly to cervical spondylosis, the definition of lumbar spondylosis in the Statements of Principles has two main facets; the symptomatic features, e.g. pain and stiffness in the described lumbar regions, and the degenerative features of the spine, which are usually identified through imaging.
There is some discrepancy in the terminology used in the literature, as well as in outcomes measured. Often lumbar spondylosis equates in the literature to degenerative disc disease of the lumbar vertebrae, or specific degenerative features, and may not always correspond to the diagnosis of lumbar spondylosis as specified by the Statements of Principles, which includes radiologically defined features combined with symptoms such as pain and stiffness.
Various terms used in the literature which have been applied to lumbar spondylosis are lumbar disc degeneration, (lumbar) degenerative disc disease, degenerative arthritis affecting the (lumbar) spine, osteoarthritis of the (lumbar) spine osteoarthrosis of the (lumbar) spine, and osteochondrosis.
References are also made in the literature to 'rheumatism. This is a very broad term referring to diseases of the joints and related structures, and involving pain and stiffness. This term is used less commonly now than it was in the past. Certain authors cited in this decision may have included lumbar spondylosis in the category of 'rheumatism', but not all rheumatism refers to lumbar spondylosis. For example rheumatic diseases may include 'rheumatoid arthritis which is an autoimmune disease that is not related to lumbar spondylosis.
The term disc degeneration:
is commonly used for an overall subjective impression of imaging findings, including signal loss, bulging, herniation, end plate irregularities, osteophytes and narrowing of the disc space.
As noted in paragraph [ REF _Ref344902969 \r \h \* MERGEFORMAT 36] above, the Council's preliminary decision on the scope of this review was: 'the possible inclusion of a factor or factors in respect of:
Repetitive or persistent flexion, extension or twisting of the lumbar spine.
Whilst the first Applicant submitted to the Council in the course of the oral hearing that his contention was that twisting and turning alone, without an association with prolonged bending forward and lifting, should be included as a factor in the Statements of Principles he also went on to contend that the factor as it stood in 2002, should be included.
The Council noted he relevant factors in the Statements of Principles, until revocation in 2005, referred to:
repetitive or persistent flexion, extension or twisting of the lumbar spine
The Council noted there are two distinct aspects to the contention:
persistent (prolonged, forward) flexion (i.e. bending); and
repetitive movement, such as extension or twisting.
In its consideration of the sound medical scientific evidence, the Council carefully considered how each study addressed either or both of these two aspects of the contended factor, noting that the terminology used within studies varied. For example, forward flexion was referred to in some studies as prolonged or sustained forward bending, forward bent posture, stooping/stooped posture and extreme stooping posture. Extension or twisting studies also refer to axial rotation or torsion.
For consistency and comprehension, within these reasons, the Council has retained the wording used for the two categories as outlined at [ REF _Ref349131950 \r \h \* MERGEFORMAT 147] above.
The Council also noted that a number of the cited studies address the issue of heavy work and weight-bearing activities either separately or in conjunction with repetitive or persistent flexion, extension or twisting of the lumbar spine
As the current Statements of Principles have factors for 'carrying or lifting loads
while bearing weight through the lumbar spine', the Council has focused its consideration on repetitive or persistent flexion, extension or twisting of the lumbar spine and referred in these reasons to carrying or lifting loads in terms of exclusion or confounding.
THE REVIEW COUNCIL'S ANALYSIS OF THE INFORMATION IT CONSIDERED MOST IMPORTANT AS BEING POTENTIALLY REFERABLE TO THE CONTENDED FACTORS for 'Repetitive or persistent flexion, extension or twisting of the lumbar spine.'
Seidler, A. Bolm-Audorff, U. Heiskel, H. Henkel, N. Roth-Küver, B. Kaiser, U. Bickeböller, R. Willingstorfer, WJ. Beck, W. Elsner, G. 2001, The role of cumulative physical work load in lumbar spine disease: risk factors for lumbar osteochondrosis and spondylosis associated with chronic complaints. Occupational & Environmental Medicine, vol. 58, no.11, pp.735-46. (RMA ID 24299)
The authors conducted a case-control study
to investigate the relation between symptomatic osteochondrosis or spondylosis of the lumbar spine and cumulative occupational exposure to lifting or carrying and to working postures with extreme forward bending.
Subjects were recruited from six German clinical centres. Cases were 229 males aged between 25 and 65 years with confirmed osteochondrosis or spondylosis of the lumbar spine and chronic low back pain complaints. Of these 135 also had reported acute lumbar disc herniation, and 94 had osteochondrosis or spondylosis, without disc herniation.
Controls were 197 eligible males, all without history of back complaints: 107 from a general population sample of age matched males, 90 from a clinical sample of urolithiasis patients.
A validated questionnaire was used to document musculoskeletal symptoms.
Structured interviews were used to gather detailed occupational exposure data, including descriptions of the objects that had been lifted and carried. A formula for estimating cumulative exposure to lifting or carrying was used to incorporate duration, load weight and trunk flexion and standard coding was used for occupations. This data was also used to construct a job exposure matrix.
Reliability testing found that agreement of the self-reported data was good to excellent.
Logistic regression was used to adjust for: age, region, nationality, and conditions which might affect lumbar discs: malposition of hip or pelvis, leg length discrepancy, scoliosis. Other potential confounders explored were: smoking, body mass index, sedentary work; various sporting and recreational activities; and psychosocial factors.
Low back pain was found to be strongly associated with radiographic signs of osteochondrosis or spondylosis with an odds ratio (OR) of 5.4 and a 95% confidence interval (CI) of 2.2-13.0.
Excluding cases with a history of lumbar disc herniation, high physical workload had a strong and significant association with symptomatic osteochondrosis or spondylosis (OR 6.5, 95% CI 2.7-16.1), with a marked dose-response relationship. Cumulated lifting/carrying >150,000kg had a strong association with these outcomes (OR 8.5, 95% CI 3.1-23.2).
The category of extreme forward bending (>90 degrees trunk flexion) for up to 1500 accumulated hours was associated with a significantly increased risk of symptomatic osteochondrosis or spondylosis (OR 2.0, 95% CI 1.2 -3.5). This association increased when there were greater than 1500 accumulated hours (OR 4.3, 95% CI 2.3- 8.0).
When cases with disc herniation were excluded, there was a strong and statistically significant association between extreme forward bending >1500 accumulated hours and 'pure osteochondrosis or spondylosis' (OR 3.5, 95% CI 1.5-7.9).
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