RESEARCH - Spinal fusion not much better than intensive rehab for chronic low back pain

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Spinal fusion not much better than intensive rehab for chronic low back pain

Rheumawire

May 26, 2005

Janis

Oxford, UK - Lumbar fusion as a treatment for chronic low back pain has

become more common in the past decade, but both the rationale and the

techniques used have been challenged. Sorting out the facts about

spinal-fusion surgery was made a priority by the UK National Health Service

in 1994, and a multicenter, randomized trial done in 15 UK hospitals has now

been reported online May 23, 2005 in the BMJ by Dr Fairbank on behalf

of the Spine Stabilisation Trial Group [1]. This report is accompanied by a

cost-benefit analysis on the same population by Dr Oliver Rivero-Arias and

colleagues [2].

According to Fairbank, " No clear evidence emerged that primary spinal-fusion

surgery was any more beneficial than intensive rehabilitation. " Rivero-Arias

adds, " Two-year follow-up data show that surgical stabilization of the spine

may not be a cost-effective use of scarce healthcare resources. However,

sensitivity analyses show that this could changefor example, if the

proportion of rehabilitation patients requiring subsequent surgery continues

to increase. "

Little difference in outcomes with surgery vs rehab

The trial randomized over 300 patients who were considered to be candidates

for spinal-fusion surgery because they had chronic low back pain despite

conventional medical management (median duration of pain eight years [range

1-35]). Patients were randomized to surgery (n=176) or to intensive

rehabilitation (n=173). The local surgeon chose the type of spinal

stabilization used. The rehab program included a three-week paced exercise

program, hydrotherapy, and " education based on principles of cognitive

behavior therapy. " Patients were followed for 24 months.

The main objective of the Fairbank study was " to determine whether surgical

stabilization of the spine (by fusion or flexible stabilization) was more or

less effective at achieving worthwhile relief of symptoms over a two-year

period than an intensive rehabilitation program based on principles of

cognitive behavior therapy. " The primary outcome measures at 24 months were

the Oswestry low back pain disability index (ODI) and the shuttle-walking

test of walking speed and endurance.

Secondary outcomes included the Short Form 36 general health questionnaire

(SF-36), the distress and risk assessment method (DRAM), assessment of

complications, and work status.

The Oswestry scores improved in both groups over the two-year period but

improved slightly more in the surgery group (a difference of 4.1 points,

p=0.045). The study (designed in 1995) was powered to detect a four-point

difference on the Oswestry scale, but Fairbank tells rheumawire that this

difference now appears too small to be clinically meaningful. " Others

suggest a minimal change for an individual following an intervention of

between 12 and 15 points on the ODI and for a group of between 6 and 10

points, " he says. There were no significant differences between surgery and

rehabilitation for any of the other primary or secondary outcome measures,

except that 19 surgical cases had intraoperative complications and 11

surgery patients required further operations on their lumbar spine during

the follow-up period.

" If you were the patient with chronic low back pain, which treatment would

you go for? " Fairbank asks. " Above all, rehabilitation needs to be offered

by a surgeon (or rheumatologist) with encouragement, and not by one who

says, 'See you later for the fusion.' "

Many more of the patients randomized to rehabilitation later crossed over to

surgery within the two-year study period than vice versa (28% vs 4%).

However, Fairbank puts this into perspective: " This was a pragmatic trial of

a population of patients considered candidates for fusion. Thus, 100% were

prepared to have an operation at the time of consent. Only 28% chose to have

a fusion after rehab, " he says.

As might be expected, intensive rehabilitation was much less costly than

surgery (1615 pounds vs 7610 pounds). At two years of follow-up, overall

costs averaged 4526 pounds for each rehabilitation patient vs 7830 pounds

for each spinal fusion patient (p<0.001). The measure health economists use

to determine whether a new procedure is " worth it " is typically some form of

the " quality-adjusted life-year " (QALY), which estimates how much would have

to be spent on all such procedures to gain a single additional year of

good-quality life for a single patient. In the UK that amount is 30 000

pounds. In the US, it is about $50,000.

" Reading off from the cost-effectiveness acceptability curve suggests that

there is less than a 20% chance that surgery will be cost-effective. This is

what we used as the basis for the conclusion that surgery is unlikely to be

a cost-effective use of healthcare resources at two years, when compared

with intensive rehabilitation, " coauthor Dr Helen tells rheumawire.

" [Our] results should encourage surgeons to refer patients to rehabilitation

'with enthusiasm,' rather than implying that they will see them back when

they have finished their rehab. "

" Strong evidence that these programs should be reinstated "

Fairbank also views the data as " evidence to encourage patients to embark on

rehab and a weapon for the doctor to demand funding for this treatment from

insurers. "

Gaining access to and reimbursement for such intensive rehabilitation

remains a problem both in the US and in the UK. Fairbank says that in most

cases, the programs were set up in community hospitals just for the trial.

" Many elements of this approach were used in the military (especially the

Royal Air Force) from the time of World War II, " Fairbank says. " These

programs had been removed from many hospitals for economic reasons. We

believe this trial provides strong evidence that these programs should be

reinstated (a situation that is also present in the US, I believe). "

Sources

1. Fairbank J, Frost H, -Mac J, et al. Randomized

and controlled trial to compare surgical stabilization of the lumbar spine

with an intensive rehabilitation programme for patients with chronic low

back pain: the MRC spine stabilisation trial. Brit Med J 2005;

DOI:10.1136/bmj.38441.620417.8F.

2. Rivero-Arias O, H, Gray A, et al. Surgical

stabilization of the spine compared with a programme of intensive

rehabilitation for the management of patients with chronic low back pain:

cost utility analysis based o a randomized controlled trial. Brit Med J

2005; DOI:10.1136/bmj.38441.429618.8F.

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Mayo Clinic in Rochester

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