Surgery May Be No Better Than Intensive Rehabilitation for Chronic Low Back Pain

[Alastair]

Again from Medscape 01/06/05

Surgery May Be No Better Than Intensive Rehabilitation for Chronic Low Back Pain




NEW YORK (Reuters Health) May 23 - Intensive rehabilitation that includes a cognitive behavioral component appears to be as effective as spinal fusion for the treatment of chronic low back pain, members of the British Spine Stabilization Trial Group report in the British Medical Journal Online First published on May 23rd. The Group also found that surgery is significantly more costly.

Dr. Jeremy Fairbank, at Nuffield Orthopaedic Centre in Oxford, and his associates recruited 349 patients from 15 centers in the UK. "Patients who were candidates for surgical stabilization of the spine were eligible if the clinician and patient were uncertain which of the study treatment strategies was best," the authors explain in their report.

A total of 176 were allocated to surgery and 173 to rehabilitation. Surgical technique was left to the discretion of the operating surgeon. Rehabilitation comprised education and exercise for 5 days per week for 3 weeks, followed by follow-up sessions at 1, 3, 6, or 12 months. Cognitive behavior therapy was added "to identify and overcome fears and unhelpful beliefs that many patients develop when in pain."

Primary outcomes were Oswestry low back pain disability index score and the shuttle-walking test; and secondary outcomes were responses to the SF-36 short form and to the Distress and Risk Assessment Method (DRAM) scores.

Oswestry scores improved more in the surgery group (mean -4.5 difference after imputation for missing follow-up data, p = 0.02). "Clinically this difference is small considering the potential risk and additional costs of surgery," the authors note.

Other measured outcomes did not differ between groups.

The authors note that 48 patients in the rehabilitation group underwent surgery by the 24-month follow-up.

"Although some patients and surgeons were clearly not satisfied with the results of rehabilitation, many more seem to have benefited and avoided surgical intervention," they write.

In a second paper in the journal, Dr. Helen Campbell of the University of Oxford and members of the Trial Group followed the same cohort of patients to compare cost-effectiveness of the two treatment methods.

After 24 months, costs of spinal fusion added up to 7830 pounds, while rehabilitation cost 4526 pounds.

The authors observed no significant difference between groups in quality-adjusted life years (QALY) gained over 24 months (1.004 for surgery, 0.936 for rehabilitation, p = 0.13).

"The incremental cost per QALY of using a policy of immediate surgery was estimated to be 48,588 pounds," Dr. Campbell's group reports.

"Although a policy of spinal fusion surgery as first-line therapy for chronic low back pain seems not to be a cost effective use of healthcare resources at 2-year follow-up, our analyses have shown that this conclusion could alter if the number of rehabilitation patients subsequently receiving surgery continues to increase in the future," they conclude.

BMJ Online First 2005.

[ans]

Thanks. Not the best prognosis for fusion.

Read it carefully. This study is making some conclusions based on some pretty crappy design and crappy interpretation of the data. First, the study was done on patients where "the doctors and the patients were unsure which treatment was best." In other words, the patients who were determined to definitely NEED fusion, were NOT included in the study.

So clear fusion candidates were exluded. Despite this limitation which would make it LESS likely to find positive fusion effects, Fusion patients fared significantly BETTER on the primary outcome. Not only that, the findings where there were "no significant differences" were pretty close. P=.13 means that there is only a 13% chance that the differences were'nt real (conversely, an 87% chance there WAS a benefit of fusion over therapy). IN science, we accept p=.05 or lower, but 13% null effect (87% chance there is a good effect) is still something I would bet on.

The use of cost effectivness is a crappy measure of you are the one in pain. Moreover, the author's comments on the fusion advantage over the therapy as "not being clinically signficant" is pretty bold and presumptions. First, there is a lot of error variance in these tests, so a 4-point difference on a noisy measure may be a much larger difference ion reality. This is ESPECIALLY true since the study sample were patients that weren't clear candidiates for fusion. More importantly, although "statistical significance" is determined by the p-value of the statistical test, it should be the patient that decides what is "clinically significant," NOT the doctor.


Conclusion: this is a lousy study which had a design that biased teh results toward NOT finding a benefit of fusion, given that "clear fusion candidates" were excluded. Yet even with this limitation, these "borderline fusion candidates" fared significantly better than therapy on the primary outcome measure. On other measures the differences were very close to "significant."

Lousy study with misleading conclusions by the media, and the authors.

Paul "Science Critic" Ph.D.

[Rein]

These two posts - Alastair's research, leading to the posting of an article, and Paul's professional assessment of the article are one of the reasons I'm so grateful Rich started the ADR Support website and this forum. It's so great to have industrious and very qualified individuals contributing on a regular basis. Thanks, guys!

[Mariaa]

I had read this article and didn't comment earlier.

Prior to my first surgery, I had 7 years of physical rehab on and off for major "back out" episodes...

Finally came the time for my first discectomy which helped me IMMENSELY. I was like a new person for almost 2 years, until the level above went bad. For this I rehabed 9 months. It's true I got better with this but still had problems. After the 2nd discectomy I got much worse. Based on this I never had the proposed 3 level global fusion.

However, I had plenty of physical rehab and though it got me thru rough spots and helped me for short periods I believe, quite truly, I'm only "feeling" better now thanks to opioid medication & neurontin and whatever I'm doing (walking) that keeps me somewhat physically a tiny bit in shape.

Thanks PS Stewart for your critical evaluation, and explaining the design more in detail to us~

[lisa]

I think it's also significant that 20% of the rehab group had surgery within the 2 year followup period.
That's not a small amount

[Fortitudine]

Thanks for your critical assessmant, Paul. It's so helpful to have a 'pro' look at these studies.

However, I do think that the premise was a fair one. I don't believe the goal was to determine the validity of fusion per se, but rather to determine if a first line treatment of physio/rehab was preferable to immediate fusion in those cases where fusion is not the obvious choice. I think that the majority of lumbar problems(and maybe cervical) probably fall into that category. Look at the rate for failed back surgery. And it's possible that without a lot of hard info to go on, some doctors tend to choose fusion too often/soon.

The study was really too small to give any meaningful results, given the variables: consistency of rehab programs, number of surgeons, techniques, and abilities involved. Many more will be needed to give a clear picture.

When you are in excruciating pain, yes, it is not really relevant how much money is being saved; I would hope that no one would have to go through two years of hell just to fit a study profile before surgery! I certainly wouldn't!

Nevertheless, in countries with public or semi-public systems, there are serious cost concerns that need to be addressed. If studies such as these can eventually give us a clearer picture of when surgery is indicated versus rehab, it could make the process more effective as well as cost-efficient. It may, for example, give doctors better guidelines and support in choosing the course of treatment.

I know that there was a major study done in Australia re lumbar rehab, one that is being duplicated here in western Canada right now, which showed definite advantages to a guided rehab program.

I know that rehab has staved off surgery for me for at least 14 years; if I should eventually go under the knife, I will know that it isn't because I haven't tried the alternative! BTW I have no bones to pick here - just my thoughts based on my experience.

[Alastair]

Hi folks,
I deliberately posted that from Medscape, because I feel that many of the people here don't realise what a huge surgery ADR is, also at the moment is ADR is extremely "fashionable" in the USA with the surgeons who want to get plenty of practice in. The site it came from is an American one, so please draw your own conclusions
Best wishes,
Alastair

ALastair -

It was good that you posted this as it promotes discussion, and the quality of the study in no way reflects on you. Thanks for doing this.

FOrtitude -

Point taken. Still, I wish it was better.

Paul

[Alastair]

Hi Paul,
I felt I had to post a little bit of the "Real World" as ADR is going at a great pace in the USA.

We want the "Happy stories " here in the future not the sad ones
Best
Alastair