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injuryupdate
10-12-2004, 08:02 PM
From this week's BMJ, studies showing manipulation better than exercise (or no treatment) for back pain. Some of the paper:

United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care
UK BEAM Trial Team

Objective To assess the cost effectiveness of adding spinal manipulation, exercise classes, or manipulation followed by exercise ("combined treatment") to "best care" in general practice for patients consulting with low back pain.

Design Stochastic cost utility analysis alongside pragmatic randomised trial with factorial design.

Setting 181 general practices and 63 community settings for physical treatments around 14 centres across the United Kingdom.

Participants 1287 (96%) of 1334 trial participants.

Main outcome measures Healthcare costs, quality adjusted life years (QALYs), and cost per QALY over 12 months.

Results Over one year, mean treatment costs relative to "best care" were £195 ($360; 279; 95% credibility interval £85 to £308) for manipulation, £140 (£3 to £278) for exercise, and £125 (£21 to £228) for combined treatment. All three active treatments increased participants' average QALYs compared with best care alone. Each extra QALY that combined treatment yielded relative to best care cost £3800; in economic terms it had an "incremental cost effectiveness ratio" of £3800. Manipulation alone had a ratio of £8700 relative to combined treatment. If the NHS was prepared to pay at least £10 000 for each extra QALY (lower than previous recommendations in the United Kingdom), manipulation alone would probably be the best strategy. If manipulation was not available, exercise would have an incremental cost effectiveness ratio of £8300 relative to best care.

Conclusions Spinal manipulation is a cost effective addition to "best care" for back pain in general practice. Manipulation alone probably gives better value for money than manipulation followed by exercise.



An economic evaluation found that physiotherapy led exercise classes for back pain were less expensive and more effective than general practice care alone.1 In contrast, a Finnish study found that patients randomised to exercise had higher costs and poorer outcomes.2 A Swedish study found no differences in costs or outcomes between physiotherapy and chiropractic manipulation,3 whereas a UK trial comparing private chiropractic and NHS outpatient treatment found that reductions in time off work more than offset the net health service cost incurred by chiropractic treatment.4 To reduce the uncertainty surrounding the cost effectiveness of these physical treatments for back pain, we report the economic evaluation of the UK BEAM trial.5


Methods
Interventions
"Best care" in general practice (the "comparator" treatment)—We trained practice teams in "active management" and provided The Back Book for patients.

Exercise programme—This comprised an initial assessment and up to nine classes in community settings over 12 weeks.

Spinal manipulation package—The UK chiropractic, osteopathic, and physiotherapy professions agreed to use a package of techniques developed by a multidisciplinary group, during eight sessions over 12 weeks.

Combined treatment—Participants received six weeks of manipulation followed by six weeks of exercise. Treatments were otherwise those given to the manipulation only or exercise only groups.

Study design
We randomised participants between these four interventions. We also randomised participants receiving manipulation between private and NHS premises. As we did not find statistically significant differences in outcome between manipulation in NHS and private premises, this paper analyses the simpler two by two factorial trial.

Results

Recruitment
We recruited 1334 participants from 181 practices around 14 centres. Of these, 1287 (96.5%) yielded enough data for inclusion in the economic analysis; 326 received best care in general practice, 297 received best care plus exercise, 342 received best care plus manipulation, and 322 received best care plus combined treatment.

Clinical outcomes
Exercise achieved a small functional benefit at three months but not at one year; manipulation achieved a small to moderate benefit at three months and a small benefit at one year; and combined treatment achieved a moderate benefit at three months and a small benefit at one year.5 These benefits were specific to back pain, in contrast to the general health benefits determined in this paper.

Discussion

Principal findings
This economic evaluation supports and extends the findings of the clinical evaluation of the UK BEAM trial reported in the accompanying paper.5 If decision makers value additional quality adjusted life years (QALYs) at much less than £3800, "best care" in general practice is probably the best strategy. If their valuation lies between £3800 and £8700, spinal manipulation followed by exercise classes ("combined treatment") is likely to be the best treatment. If their valuation is well above £8700, manipulation alone is probably the best treatment.

Strengths and weaknesses of the study
The sensitivity analysis that removed 51 "outliers" from the UK BEAM dataset, was more favourable to manipulation than was the primary analysis. Under this scenario manipulation cost only £3000 per QALY relative to best care in general practice.

We believe that this is the first study of physical therapy for low back pain to show convincingly that both manipulation alone and manipulation followed by exercise provide cost effective additions to care in general practice. As we trained practice teams in the best care of back pain, we may have underestimated the benefit of physical therapy when compared with "usual care" in general practice.

What is already known on this topic
Back pain is a major economic problem

Little evidence exists for the effectiveness and cost effectiveness of two commonly used treatments—exercise classes and spinal manipulation

What this study adds

Spinal manipulation, exercise classes, and manipulation followed by exercise all increased participants' quality of life over 12 months by more than did "best care" in general practice

Adding spinal manipulation to best care in general practice is effective and cost effective for patients in the United Kingdom

If the NHS can afford at least £10 000 for each quality adjusted life year yielded by physical treatments, manipulation alone probably gives better value for money than manipulation followed by exercise

Unanswered questions
Funding constraints prevented us from following up participants for more than 12 months. Combined therapy depends on an ample supply of both trained manipulators prepared to work for the NHS and exercise physiotherapists with access to suitable premises. As back pain is a common problem, making manipulation generally available will require many therapists. Therapists can achieve higher incomes in private practice than in the NHS. In the short term it may be difficult to make manipulative or combined treatment generally available within the NHS.

Whereas physiotherapists can rapidly train to deliver the exercise package, insufficient trained manipulators are available to meet potential demand, and it may be decades before the NHS can implement these findings. Fortunately, using private costs for manipulation had little effect on the choice of best treatment. Purchasing manipulation from the private sector to provide treatment within the NHS would still represent good value for money if decision makers were willing to pay £10 000 per additional QALY.

Meaning of the study
Adding spinal manipulation to best care in general practice is effective and cost effective for patients with back pain in the United Kingdom. If the NHS can afford more than £10 000 for an extra QALY, manipulation alone probably gives better value for money than manipulation followed by exercise. These conclusions hold even if the NHS has to buy spinal manipulation from the private sector.

This is the abridged version of an article that was posted on bmj.com on 19 November 2004:
http://bmj.com/cgi/doi/10.1136/bmj.38282.607859.AE

hhh
24-12-2004, 04:48 PM
March 15, 2004 (San Francisco) — Epidural steroid injections may not be better than placebo, but more studies are needed to be certain, said a Canadian researcher here on Friday at the 71st annual meeting of the American Academy of Orthopaedic Surgeons.

Daniel Steinitz, MD, from the division of orthopedics at McGill University in Montreal, presented results of his randomized, controlled, double-blind study at the meeting. Fifty consecutive patients who were referred to radiology for steroid injections were randomly assigned to either a 12-mg betamethasone injection plus lidocaine and bupivacaine, or the numbing agents alone.

All of the patients had confirmed pathology with either magnetic resonance imaging or computed tomography, and those who had undergone previous back surgery or steroid injections were excluded. All injections were administered by the same blinded radiologist, who used fluoroscopy and radiocontrast to guide and confirm the placement, and all outcomes were measured by the same blinded clinician.

The patients had four visits, with the first for baseline measures on the Musculoskeletal Functional Assessment questionnaire, the Oswestry Disability Index, and the visual analog scale. At the next visit patients were given a single injection and assessed at four weeks and 16 weeks after injection. Dr. Steinitz said there was no difference in outcomes between the two groups at any time on any of the measures.

When questioned by an audience member about whether it was fair to judge outcomes based on a single injection, he acknowledged that more study was needed with multiple injections. Generally, patients are given two to three injections before judging success.

In an interview with Medscape, Dr. Steinitz said his study was important because it was one of the first to use validated assessments to analyze benefits. Of some 12 previous studies of epidural injections, most randomized and controlled, none used validated questionnaires, he said. Half of those studies backed efficacy, while half found no effect.

"We found no benefit to the addition of steroids to the epidural injection," he concluded.

Dr. Steinitz wanted to do a simple assessment of efficacy, with validated measures, he told Medscape. "It is a very popular procedure that is felt in the minds of many people to be effective, so it behooves us to prove it," he said.

While the study found no benefit, "I'm not saying steroids don't work," said Dr. Steinitz, adding that he believed his study should prompt others to try to replicate the results.

John Glaser, MD, moderator of the session and an orthopaedics professor at the Medical University of South Carolina in Charleston, agreed and said there definitely should be more study of multiple injections and in larger numbers of patients.

But Dr. Glaser told Medscape that Dr. Steinitz' study "did debunk a few myths that steroids are the answer."

Dr. Steinitz said he rarely refers patients for steroid injections, but Dr. Glaser said he still does. But he said he tells patients, "It may be worthless or it may be magical."

AAOS 71st Annual Meeting: Paper No. 188. Presented March 12, 2004.

Reviewed by Gary D. Vogin, MD

Alicia Ault is a freelance writer for Medscape.