Research Review By Dr. Michael Haneline ©

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Date Posted:

January 2011

Study Title:

Manipulation or microdiskectomy for sciatica? A prospective randomized clinical study.

Authors:

McMorland G et al.

Author's Affiliations:

National Spine Care, Calgary, Alberta, Canada.

Publication Information:

Journal of Manipulative & Physiological Therapeutics 2010; 33: 576-584.

Background Information:

Lumbar disk herniation (LDH) resulting in sciatica is a fairly common condition that affects between 2% and 40% of the general population at some point in their lives. One large population-based study reported that 5.1% of men and 3.7% of women over 30 years-of-age had LDH related sciatica (1).

Sciatica patients are typically provided nonoperative care which is effective more than 50% of the time (2). A number of different types of nonoperative care are available; however, no relevant guidelines have been established and high-quality clinical trials are lacking in this area.

LDH patients are commonly referred for a surgical evaluation when nonoperative care fails, resulting in lumbar diskectomy being one of the most frequently performed surgeries in the US (3). While improvements in sciatica patients’ symptoms favor a surgical approach over nonoperative care in the short-term, the differences in outcomes are less striking after about 1-year.

The role of spinal manipulation as a form of nonoperative care for LDH-related sciatica has not been firmly established, although a case series reported clinical improvement in 50% of chronic sciatica patients who received manipulation and manipulation was found to be more effective than heat, exercise, and postural education in a controlled trial of manipulation for LDH.

The purpose of this study was to compare the quality of life and condition specific disability levels between surgical treatment vs. spinal manipulation in patients with sciatica secondary to LDH.

Pertinent Results:

The neurosurgeons screened 120 consecutive patients for inclusion into the study; 60 of them met the inclusion criteria and were asked to participate. However, 20 selected patients refused to participate and instead elected to undergo spinal manipulation in hopes of avoiding surgery. Ultimately, 40 consenting patients were randomized, 20 to receive spinal manipulative treatment and 20 to receive microdiskectomy.
 
Findings:
  • There were no significant differences between the groups at baseline regarding demographics and/or outcomes (e.g., pretreatment pain and quality of life indicators).
  • No significant adverse events were reported in either group, although there were reports of minor adverse events in both groups that comprised increased postprocedure soreness that was self-limiting and did not require additional intervention.
  • In the spinal manipulative treatment group, 12 out of 20 (60%) patients demonstrated clear improvement in outcomes at the end of 12 weeks. These patients completed the 52-week follow-up period without crossing over into the surgical arm. Eight (40%) patients in this group did not respond to spinal manipulation very well and opted for the microdiskectomy procedure.
  • In the microdiskectomy treatment group, 17 out of 20 (85%) demonstrated clear improvements in outcomes 12 weeks following surgery. These patients completed the 52-week follow-up period without crossing over into the spinal manipulation arm. However, 3 (15%) patients did not respond to the surgical procedure very well and subsequently opted to receive spinal manipulative care.
  • The 8 patients who crossed over from the spinal manipulative therapy group to the surgery group improved at a rate and degree that was very similar to the improvements seen in the primary analyses. However, none of the 3 patients who crossed over from the surgery group to the spinal manipulative therapy group noticed any significant improvement.
  • The degree of improvement and rate of recovery for both treatment groups was similar, i.e., there were no significant differences between the groups’ McGill pain, Roland Morris disability index, or SF-36 total scores after 12 weeks of care.

Clinical Application & Conclusions:

The major conclusion of this paper is that LDH patients who have failed at least 3 months of nonoperative medical management, including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy, and/or acupuncture, should consider chiropractic spinal manipulative treatment, followed by surgery if unsuccessful.

The risk and costs associated with surgical care for this condition calls for serious physician and patient consideration of a trial of spinal manipulative therapy before surgery.

The patients in this study were considered surgical candidates, yet they improved with spinal manipulative care in a similar manner to those who underwent surgery. Patients who received spinal manipulation but did not improve, later improved following surgical intervention equally as well as the group in the primary analysis. On the other hand, the 3 patients who did not experience good outcomes following microdiskectomy did not benefit from further spinal manipulative care.

Patients who failed to improve following spinal manipulation were delayed in receiving surgery. However, there was no evidence that this delay adversely affected their level of improvement after the surgery was finally performed.

One observation in this study that was amazing to me was that the type of conservative care patients had received prior to presenting for participation in this study was mostly passive in nature, mainly consisting of medication and rest. Furthermore, those who had received previous physiotherapy treatment reported that it was focused on pain relief, relying on modalities rather than active rehabilitation. This serves as a reminder for evidence-informed clinicians to continue focusing on active treatment and rehabilitation strategies that engage and empower our patients.

Study Methods:

This study used a randomized clinical design in which three spinal neurosurgeons screened patients for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3-4, L4-5, or L5-S1. Eligible patients were asked if they wanted to participate. Those who consented were then counseled by a nurse clinician who was not blinded as to the randomization assignments about the purpose, risks and potential benefits of the study.

The study inclusion criteria were as follows:
  • the presence of leg-dominant symptoms with objective signs of nerve root tethering ± neurologic deficit that correlated with evidence of root compression seen on MRI, and
  • patients must have failed at least 3 months of nonoperative management.
Participants were excluded for the following reasons:
  • radicular symptoms for less than 3 months;
  • concurrent or previous spinal manipulation treatment;
  • major neurological deficits;
  • substance abuse;
  • hospitalization for intravenous or intramuscular narcotics;
  • systemic or visceral disease;
  • hemorrhagic disorders, anticoagulation therapy;
  • previous surgery at the symptomatic level;
  • prolonged use of systemic corticosteroids;
  • osteopenia/osteoporosis;
  • grade III or IV spondylolisthesis;
  • unable to read or speak English;
  • < 18 years-of-age; or
  • pregnancy;
  • dementia or other cognitive impairment; or
  • unavailable for follow-up.
Eligible and consenting patients received baseline neurologic examinations and data were collected on the outcome measures as well as demographic details. A blinded researcher then randomized the subjects to receive either microdiskectomy or spinal manipulation. Patient recruitment was concluded when the target of 20 patients had been randomized into each group. All participants were contacted by the research assistant by telephone at 3, 6, 12, 24, and 52 weeks after treatment was initiated to complete follow-up surveys.

Patients who did not report improvements in their baseline outcome measures within 12 weeks of commencing spinal manipulation or microdiskectomy were classified as nonresponders. These patients were immediately allowed to cross over to the opposite treatment group and then were observed for 52 additional weeks.

Outcome measures included the following:
  • Short Form (SF-36)
  • McGill Pain Questionnaire
  • Aberdeen Back Pain Scale
  • Roland-Morris Disability Index
The lead author, who is a doctor of chiropractic, provided all of the spinal manipulation using a side-posture, high-velocity, low-amplitude, short lever technique. If there was peripheralization or significant exacerbation of a patient's leg symptoms when positioning them for spinal manipulation, it was considered a contraindication to treatment for that visit. Two patients could not tolerate spinal manipulation due to pain and were subsequently crossed over to receive microdiskectomy.

In addition to spinal manipulative treatment, patients in this arm received “as-needed” ice or heat therapy to help them tolerate the treatment better. The spinal manipulation patients were also given a package of information/education material covering basic spinal hygiene and self-care recommendations, plus they were introduced to rehabilitative exercises.

Patients in the spinal manipulation group typically required 2 to 3 visits per week for the first 4 weeks and 1 to 2 visits per week for the next 3 to 4 weeks. Follow-up visits were scheduled based on the patients’ symptoms until they were deemed stable.

The microdiskectomies involved sequestrectomy and intraannular discectomy and were performed at the level of the LDH with patients in a prone position using microsurgical techniques via an operating microscope. Patients were managed in hospital for 1 to 2 days postoperatively and were given a prescription for oral analgesia and advised to avoid heavy lifting, bending or twisting until their follow-up appointment.

Patients in both the spinal manipulation and microdiskectomy groups participated in a supervised rehabilitative (core stability) exercise regimen that involved 6 supervised sessions.

Study Strengths / Weaknesses:

This was a very well conducted study; however it was small and the authors acknowledged that it was a pilot study. Therefore, its findings are preliminary and need to be confirmed in subsequent studies. Indeed, one of the objectives listed was to assess the feasibility of the recruitment and randomization process, choice of outcome measures, and effect size to inform a future large-scale clinical trial.

Sham or non-treatment groups were not included, so there is no sure way to determine if improvements might have been related to a placebo effect or natural history. Thus, the hypothesis that surgery and spinal manipulation treatments are no different than the natural history of symptomatic LDH was not tested.

In the purest sense, one cannot know from this study whether spinal manipulation was effective because it was provided in conjunction with ice or heat therapy and rehabilitation. It is possible that if a group of patients had received only ice or heat therapy and rehabilitation without spinal manipulation, they might have fared just as well.

Additional References:

  1. Heliövaara M. Body height, obesity, and risk of herniated lumbar intervertebral disc. Spine 1987;12:469-72.
  2. Saal JA, Saal JS. Non-operative treatment of herniated lumbar intervertebral disc with radiculopathy. An outcome study. Spine 1989;14:431-7.
  3. Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Longterm outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10-year results from the maine lumbar spine study. Spine 2005;30:927-35.