YET ANOTHER MIRACLE CURE FOR LOW BACK PAIN
John W. Reggars D.C., M.Chiro.Sc.

The television current affairs program stated “startling results” and the newspaper article read “back pain triumph”. They were both referring to a “new” surgical technique for the treatment of lumbar spine intervertebral disc herniation, percutaneous endoscopic laser discoplasty.

This treatment, along with several others including chemonucleolysis and a moulded back brace, have of recent times have been featured on television or in the print media and promoted as back pain cures. But are they?

In my 25 years of practice I have been exposed to numerous medical and non-medical miracle treatments for low back pain and or sciatica, including some chiropractic and osteopathic techniques. Unfortunately most, rather than standing the test of time, have withered on the vine. I cannot say with any certainty that these latest fads will also die a natural death but what I can tell you is what a brief review of the literature reveals.

Percutaneous Laser Disc Decompression

Percutaneous laser disc decompression (PLDD) has been used clinically for the treatment of intervertebral disc prolapse since 1987/88. Briefly, the technique involves a making small incision under local anaesthetic in the back, lateral to the spine, and then via needle Xray guidance locating the involved disc. Once the disc has been identified, a laser fiberoptic is introduced into the nucleus and a small portion of the nucleus is vaporised by the pulsed beams of the laser, in an attempt to reduce intradiscal pressure.

One study of 180 patients treated with PLDD from 1989 to 1993 showed a success rate similar to other percutaneous techniques such as chemonucleolysis (1). Choy et al (2) reported on the clinical use of laser discectomy on 420 patients in whom there was disc prolapse, without sequestration, and found a fair or good result in 78% of the treatment group. The authors also reported that there were no complications or side-effects. So on face value, this particular procedure seems a safe and effective means of treatment for contained lumbar intervertebral disc prolapse. However, in a review of laser disc surgery by Sherk (3) the author stated these trials did not include a control group and none of the evaluators of the treatment were blinded as to the treatment administered, and that some of the post-operative evaluations included the use of a number of subjective criteria. Further, in a later study on laser discectomy (4) similar results to those of Choy et al (2) were reported but in this study a control group was used, who were non-surgically managed and then compared to the surgical group. In his review paper Sherk (3) states “The treated and control groups had similar results indicating an apparent failure of the treatment protocol to resolve symptoms and improve function in the patients who had discectomy with the use of the laser…..At this time, laser discectomy has a limited role in the management of patients who have low back pain and sciatica”. The Cochrane Collaboration (5) has also begun to investigate the role of surgery in the treatment of low back pain. With particular reference to laser discectomy they state that the methodology employed by Choy (2) is questionable and that although some other reports from the US suggest similar success rates of PLDD (4) other preliminary reports suggest that the results are much poorer.

The particular technique featured on television, percutaneous endoscopic laser discoplasty, was promoted by its “inventor” and visiting orthopaedic surgeon, Dr. Richard Richley. According to the television interview Dr. Richley has performed in excess of 650 of these procedures with a success rate of 88-92%, as assessed by the patients’ reduction in pain, and without complications. A review of the literature fails to locate any published paper on this technique by Dr. Richley.

Personal communication with Dr. Richley confirmed this fact and that he has not published his results. His results are based on an unpublished simple case series without any control group. Within the scientific community this type of study is ranked low in the hierarchy of studies evaluating the efficacy of an intervention. Applying the results of this type to the general population is not considered valid, even when it is published in a peer reviewed journal. According to his correspondence the inclusion criteria were contained herniated lumbar discs, “clinical disc syndrome”, positive imaging studies for disc herniation, including MRI and myelogram, and failed conservative therapy greater than six weeks. The patients were assessed pre/postoperatively, at ten days, six weeks, three months and one year, using a visual analogue scale (VAS) by one of his nursing staff. Some other subjective criteria were also used in the assessment plus pre and post physical examination findings. Unfortunately, no information was available on how his results were interpreted or tabulated. Therefore, what does an 88-92% success rate represent? Was there a complete resolution of the patient’s symptoms? What was the improvement in VAS scores and physical examination parameters? Success in this sense is a relative term and a 10% improvement in any of the assessment criteria may well have been classified as a success. Stern et al (6) in case study of 59 subjects with low back and leg pain also reported a 90% improvement after a course of conservative therapy, including chiropractic spinal manipulation. On the information available the latter study was by far better designed and methodologically correct but in the final analysis one can only conclude that it may be an effective treatment for low back and leg pain.

Personal communication with a Melbourne orthopaedic surgeon, assisting in the establishment of a local trial on this technique, estimates that the procedure would be suitable in Australia for only 100-220 patients per year. Furthermore, given that the majority of disc herniations spontaneously improve (7) and that 90% have a successful outcome when treated non-operatively (8) it may be that Dr. Richley is merely reporting the success of natural history rather than his new surgical procedure. There is a 10-fold variation in the incidence of back surgery between the United States and Great Britain and with respect to natural history one researcher postulates “Perhaps surgeons are generally less aggressive in Great Britain, or perhaps the length of the waiting lists on the National Health Service allow sciatica to follow its natural course.”(9)

Furthermore, any procedure which it is promoted by someone with a vested interest in that procedure, should also be carefully investigated, particularly when the studies extolling its benefits are not peer reviewed. It makes no difference whether it is a chiropractic or osteopathic technique, a surgical procedure or a drug, bias, either purposeful or otherwise, may have a profound affect on the outcome of the study. What I also found of interest is that the clinic in California where Dr. Richley is domiciled has a Internet Website and that amongst other things advertises for investors.

Chemonucleolysis

Chemonucleolysis also uses image intensified guidance to locate the involved disc, into which is injected an enzyme that lyses the nucleus. The procedure has been used for 30 years using different enzymes but most notably chymopapain, which appears to have been the most successful. It was also promoted on television and portrayed in glowing terms as a cure for low back pain. Before and after segments showed a professional fisherman disabled by low back pain and then some weeks after surgery lifting, in a forward flexed position, heavy crates full of fish without restriction or pain.

A brief literature search on this surgical technique revealed many studies supporting its efficacy. For example a review paper by Brown (10) states that , “The world literature supports the use of chymopapain for chemonucleolysis as a safe and effective alternative to surgical disc excision. The efficacy of chymopapain has been shown by prospective, randomised, placebo-controlled, double-blind trials with a minimum 10 year follow-up period.” In another review paper (11) the author concludes “At present, of all percutaneous methods, lumbar chymopapain nucleolysis is the only procedure that has withstood the test of time.” The Cochrane Collaboration, however, is somewhat more cautious in their assessment of the technique, stating that although at one stage being strongly recommended by spinal surgeons for contained disc prolapse, some 30 years later the value of such treatment still remains a matter of dispute (5).

With respect to whether this is a safe procedure, percutaneous procedures are generally associated with less risk of complications, but all surgery, whether it be percutaneous or open is accompanied by some form of risk. In one study on chemonucleolysis between 1982-1991, 121 adverse events in 135,000 patients were recorded with a mortality rate of 0.019%. (12) That is 19 deaths per 1000 procedures and on my reckoning that’s not what I call safe, particularly when compared to spinal manipulation (13) which has been shown, albeit inconclusively, to be effective in the treatment of disc herniation. (6)

One interesting Australian study (14) unearthed was a double-blind trial to assess the long term morphologic changes of the disc after treatment with chemonucleolysis and laminectomy and then comparing the findings with the natural history of the disorder. Only 39 subjects were included in the trial, 12 were treated with only saline injection of the disc, 14 underwent chemonucleolysis and 13 underwent laminectomy. MRI examination ten years later revealed that 37% of the group were found to still have a herniated disc and that the incidence was similar for all three groups of subjects. The authors concluded “The findings of this study indicate that long term improvement of a patient’s symptoms after treatment of disc herniation may occur with or without resolution of the hernia.” So if it’s not the bulge that causes the pain what is it?

The Mould-A-Back Brace

The publicity brochure reads, "Simply ... the World’s Finest Back Support, The NEW first line treatment in ACUTE LOWER BACK PAIN and chronic lower back pain." A telephone call to the distributor informed me that they had had over 20,000 interested callers for this product, which was developed, by a Perth medical practitioner, to ease the lower back pain he developed after a surfing accident. More than a dozen testimonials contained in the brochure extol its virtues and of how it has relieved the pain and suffering of the wearers. Unfortunately, this anecdotal evidence is not supported by any clinical trials. In fact there is no scientific evidence at all contained in the manufacturers literature to give credence to its efficacy for the relief of back pain.

However, the world medical literature contains numerous studies which state that there is no evidence that low back braces have any therapeutic effect on the relief of acute low back pain. Three separate clinical guidelines for the treatment of acute low back pain, the U.S. Department of Health and Human Services (15), the Victorian WorkCover Authority (16) and a consortium, including in the British Chiropractic and Osteopathic Associations (17), all reviewed the available evidence and stated categorically that there is no scientific evidence for the use of braces in the treatment of acute low back pain. There is some evidence to suggest that braces may prevent occupational low back pain but as yet this inconclusive (18). May be this new product is much better than its predecessors but until there is more evidence than just individual testimonials I will reserve my judgement.

In conclusion, world renowned back pain researcher Richard Deyo states “Much of the history of back pain therapy appears to be a succession of fads. Widespread coccygectomy and sacroiliac fusion have had their day. Modern day fads have included colchinine therapy and laser stimulation of trigger points.”(19) Another notable researcher, Alf Nachemson writes “New surgical methods are consistently being introduced and presented in uncontrolled case series. Orthopedists, trained for surgical solutions, are too quick to use the new screws, hooks, pins and needles, promoted by the inventors and the instrument companies despite mediocre results and many complications.” (20) Whether any of the above therapies live up to their therapeutic claims or become another fad that dies a natural death is still a matter for conjecture and until the evidence is on the table my opinion remains Caveat Emptor.

The majority of the information contained in this commentary was accessed via the Internet through Health Communication Network who provide access to Medline, The Cochrane Collaboration and Evidenced Based Medicine. They can be contacted via the Internet on www.hcn.net.au or 1800 622678

References

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3. Sherk HH. Current concepts review. The use of lasers in orthopaedic procedures. J. Bone Joint Surg 1993; 75-A:768-776
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15. US Dept of Health and Human Services. Clinical practice guidelines (14), Acute low back problems in adults. 1994; AHCPR 95-0642:124
16. Victorian WorkCover Authority. Guidelines for the management of employees with compensable low back pain. 1996:31
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20. Nachemson A. Low back pain - Are orthopaedic surgeons missing the boat. Acta Orthop Scand 1993; 64(1):1-2