J Manipulative Physiol Ther. 2010 (Oct); 33 (8): 576–584 ~ FULL TEXT
Gordon McMorland, DC, Esther Suter, PhD, Steve Casha, MD, PhD, FRCSC, Stephan J. du Plessis, MD, R. John Hurlbert, MD, PhD, FRCSC, FACS
Gordon McMorland, DC,
National Spine Care,
#300, 301 14th Street N.W.,
Calgary, AB, Canada T2N 2A1.
In an excellent example of the kind of comparative effectiveness research needed to distinguish the relative quality of competing treatment approaches, researchers in Alberta, Canada studied the relative costs and benefits of lumbar microdisckectomy and chiropractic spinal manipulation for patients with low back pain and sciatica associated with lumbar disk herniation for whom usual medical care had failed. The results were dramatic: 60 percent of patients with sciatica who had failed medical management benefited from spinal manipulation to the same degree as if they had undergone surgical intervention, at a far lower cost.
The economic implications of these findings are far-reaching. In the U.S., at least 200,000 microdiskectomies are performed annually at a direct cost of $5 billion, or $25,000 per procedure. Avoiding 60 percent of these surgeries would mean a reduction savings of $3 billion annually. In the Canadian study, patients receiving chiropractic care averaged 21 visits during their course of care. If a cost of $100 per patient visit is assumed for the care provided by the chiropractor, then the total cost per patient would be $2,100, yielding per patient savings of $22,900, or $2.75 billion dollars annually.
OBJECTIVE: The purpose of this study was to compare the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disk herniation (LDH).
METHODS: One hundred twenty patients presenting through elective referral by primary care physicians to neurosurgical spine surgeons were consecutively screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3-4, L4-5, or L5-S1. Forty consecutive consenting patients who met inclusion criteria (patients must have failed at least 3 months of nonoperative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy, and/or acupuncture) were randomized to either surgical microdiskectomy or standardized chiropractic spinal manipulation. Crossover to the alternate treatment was allowed after 3 months.
RESULTS: Significant improvement in both treatment groups compared to baseline scores over time was observed in all outcome measures. After 1 year, follow-up intent-to-treat analysis did not reveal a difference in outcome based on the original treatment received. However, 3 patients crossed over from surgery to spinal manipulation and failed to gain further improvement. Eight patients crossed from spinal manipulation to surgery and improved to the same degree as their primary surgical counterparts.
CONCLUSIONS: Sixty percent of patients with sciatica who had failed other medical management benefited from spinal manipulation to the same degree as if they underwent surgical intervention. Of 40% left unsatisfied, subsequent surgical intervention confers excellent outcome. Patients with symptomatic LDH failing medical management should consider spinal manipulation followed by surgery if warranted.
From the FULL TEXT Article
Most health care providers would agree that first-line treatment of radiculopathy secondary to LDH should consist of nonoperative care in the form of lifestyle modification and analgesia for pain control. Additional options include careful use of antiinflammatory medications, physiotherapy, massage therapy, local injections, acupuncture, and chiropractic treatment. However, it is when these modalities fail over a period of 6 to 12 weeks that the more invasive and expensive option of surgery is often considered. Perhaps it is the attraction of immediate anatomical restoration and ensuing pain relief that sets surgical intervention apart from other treatment modalities, or perhaps it is recognition of the attendant and relatively unique risks associated with operative intervention. Whatever the reason, surgery is generally regarded as the final solution in what is in many cases a very long journey through failed medical management.
The purpose of this pilot study was to compare clinical outcomes among patients failing nonspecific conservative care (in which the common denominator was time elapsed from onset of symptoms) who were then subjected to a regulated spinal manipulation regimen or to a traditional surgical microdiskectomy. To our knowledge, this is the first study to directly compare the efficacy of surgery against a standardized nonsurgical treatment.
It is well established that the failure rate of microdiskectomy in the relief of radiculopathy secondary to LDH is in the order of 10% to 20%. [32, 33, 34] Our observed surgical failure rate of 15% is in keeping with these previously published findings. Similarly, our observed spinal manipulation failure rate of 40% lies within the published range of 5% to 50%. [5, 7, 14, 35, 36] It is notable that our study is the first to report on manipulation treatment effects on a group of patients failing other medical management and with symptoms of more than 1 to 3 weeks in duration. Hence, it is not surprising for our patients to be perhaps more refractory to spinal manipulation therapy.
There is a large range of treatments that fall under the umbrella of “conservative” or “nonoperative” treatment. In this study's patient population, only 2 of the 120 screened had received spinal manipulation before presentation. Although guidelines have been established outlining appropriate care pathways for this patient population, our experience has been that standardized treatment approaches are not followed. The nature of conservative treatment for patients presenting for this study was largely passive in nature, consisting of medication and rest. Those patients who had undergone a course of physiotherapy had received treatment focused on pain relief (ie, modalities) as opposed to active rehabilitation. Of those patients reporting some attempts at active rehabilitation in their previous treatments, all related that any attempts at performing rehabilitative exercises were limited by pain. None of the 120 patients screened for this study had received intraspinal injections.
Using objective clinical indicators tested for validity and reliability, this study has found by intent-to-treat analyses that a relatively high number (60%) of patients failing initial medical management and deemed appropriate for surgical intervention can gain a similar amount of pain relief through spinal manipulative treatment as they might have gained from surgery. This observation appears to hold true for both rate and magnitude of recovery. Changes in clinical status were reflected in each of the measurement tools used. This consistency between the outcomes measured lends credibility to the reliable nature of the data and attest to the extremely small likelihood of study results being contaminated by random chance.
Although 40% of patients referred to spinal manipulative therapy for LDH-induced sciatica may fail to achieve satisfactory relief, the obvious risk and cost profile of operative care argues for serious physician and patient consideration of spinal manipulative therapy before surgical intervention. In the present study, 8 patients who failed primary spinal manipulative care and went on to surgical decompression ultimately benefited with clinical outcomes indistinguishable from the treatment successes. There was no evidence that delay in definitive treatment adversely affected degree of improvement. Nonetheless, further study is warranted to better identify factors predictive of spinal manipulative success and failure.
Finally, it appears that those patients who fail surgery do not benefit from further spinal manipulation intervention. Despite the small number of patients in this category, the results from the present study have shown a consistent failure of improvement in all clinical outcome measures with strong statistical significance. This observation tends to reinforce a general clinical impression that the surgical “failed back” tends to be a chronic condition refractory to other forms of intervention.
It can perhaps be argued that clinical improvement in both treatment groups was confounded by the benefits of natural history (ie, spontaneous improvement with time). However, all patients in this study had failed at least 3 months of conservative care. Approximately 80% of participating subjects (n = 32) experienced symptoms for greater than 6 months, whereas 65% (n = 26) of them experienced symptoms for greater than 1 year. These figures suggest that most of the patient population in this study were not likely to improve from natural history alone.
The main limitation of this study is its relatively small sample size (n = 40). However, statistical techniques have demonstrated it to be adequately powered in the ability to detect clinically significant differences between treatment groups. Nonetheless, for more robust conclusions with respect to the patients who failed surgical microdiskectomy, a larger sample size would be preferable. In addition, this trial was not designed to incorporate a “nontreatment” (natural history) control group; hence, the hypothesis that both surgery and spinal manipulation treatments are no different than the natural history of symptomatic LDH was not tested. Although follow-up in the present study was less than 2 years after final treatment, it is unlikely that any further significant changes would have been observed between 1- and 2-year follow-up points based on the experience of other recent prospective randomized trials. [15, 17]
Most of the patients who were considered surgical candidates for the treatment of radiculopathy from LDH improved with standardized spinal manipulative care to the same degree as those who had undergone surgery. Of those who failed spinal manipulation treatment, subsequent surgical intervention provided excellent outcome. In contrast, the 3 patients who failed microdiskectomy did not benefit from further spinal manipulative care. Therefore, patients with symptomatic LDH failing medical management (failed at least 3 months of nonoperative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy, and/or acupuncture) should consider chiropractic spinal manipulative treatment as a primary treatment, followed by surgery if unsuccessful.
Based upon this randomized clinical study, 60% of patients with sciatica
and had failed other medical management benefited from spinal
manipulation to the same degree as if they underwent
Of the 40% of patients that showed unsatisfactory results with
spinal manipulation, subsequent surgical intervention
conferred excellent outcome.
The 3 patients who failed surgical treatment and crossed over to
spinal manipulation did not gain further improvement.