Research Review By Dr. Michael Haneline ©

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Date Posted:

June 2012

Study Title:

The efficacy of systematic active conservative treatment for patients with severe sciatica

Authors:

Hanne BA & Manniche C

Author's Affiliations:

The Back Research Centre, Funen, University of Southern Denmark, Ringe, Denmark.

Publication Information:

Spine 2012; 37(7): 531-42.

Background Information:

Although low back pain (LBP) with or without sciatica is known to be very common, the actual prevalence of nerve root compression with concomitant sciatica is still somewhat vague. Two recent epidemiological studies estimated the lifetime prevalence of lumbar disc herniation to be 5% for men and 4% for women.

Lumbar nerve root compression with sciatica accounts for only a small minority of LBP patients (estimated to be only 2%), yet the costs associated with treating these patients represent about 30% of the total annual expenditure for LBP treatment in the US.

The clinical management of sciatica due to herniated discs is controversial, primarily because the natural course of the disease is so favorable. In fact, a study by Weber et al. (1) that included 208 patients with LBP radiating to the leg and clinical signs of nerve root compression reported that patients who were randomized to receive a placebo medicine did just as well as those who received treatment with an NSAID. Both groups showed significant improvement within 4 weeks and no differences between the groups were observed in any of the outcome measures at 4-weeks, 3-months, and 1-year follow-up.

Conventional practice in treating sciatica patients is to treat the patient conservatively at first, even patients with severe symptoms. Even so, there is not much evidence available on the indications for conservative treatment versus surgery, and little agreement among practitioners as to which approach is better. Moreover, the effectiveness of conservative treatment and surgery for sciatica is very similar in the long-run.

There are several conservative treatment options available to sciatica patients, although not much is known about which of them is most effective. Because there are doubts about which is the most effective conservative treatment modality for disc-related sciatica, the purpose of this study was to describe the overall efficacy of active conservative treatment in patients with severe sciatica and to compare the effect of 2 active conservative treatments on these patients.

Pertinent Results:

One hundred eighty-one consecutive patients met the inclusion criteria and were randomized to receive either the real treatment or sham treatment. Eighty six patients were assigned to the symptom guided exercise group and 95 to the sham exercise group. The dropout rate was only 2.2% for the clinical examination and 1.1% for the questionnaires, which is excellent. Furthermore, the dropout rate was distributed almost equally between the groups.

The means of both groups showed significant improvement in global assessment, functional status, pain, vocational status, and clinical findings. However, improvements in the symptom-guided exercise group were significantly more than the sham exercise group on most outcomes.

Patients were asked at the start of the study which treatment they thought would most likely be of benefit to them. Most thought that the sham exercise treatment would be more effective than the symptom-guided exercise treatment.

Treatment outcomes:
  • Global Assessment: By the end of treatment (after 8 weeks), 89.2% of all patients were “better” or “much better”, which improved to 91.1% at 1 year post-treatment. Patients in the symptom-guided exercise group noticed significantly more global improvement than those in the sham exercise group.
  • Activity Limitation: Both groups noticed statistically significant and clinically important improvements in activity limitation at both follow-up points. The median improvement was 10.0 RMDQ (Roland Morris Disability Questionnaire) points at the end of treatment and 12.5 RMDQ points at 1 year. The differences between the groups were not statistically significant.
  • Leg Pain: Statistically significant and clinically important mean leg pain improvements were reported in both groups at the end of treatment and at 1-year follow-up. On a 0 to 10 scale, the mean reduction of leg pain was 2.6 points and 3.0 points respectively. There appeared to be a trend toward a greater mean reduction of leg pain in the symptom-guided exercise group, but it was not enough to be considered significant.
  • Nerve Root Compression Signs: All patients on average noticed fewer positive signs at 1-year follow-up, but improvements were greater in the symptom guided exercise group, with 1.9 fewer signs in the symptom-guided exercise group and 1.3 fewer in the sham exercise group.
  • Generic Function – QUALY (Quality Adjusted Life Years): The mean improvement of all patients was 0.20 from baseline to the end of treatment and at 1-year follow-up, which was statistically significant. The differences were greater in the symptom guided exercise group than the sham exercise group, but they were not statistically significant.
  • Sick Leave: Overall, 35.2% of the patients in the symptom-guided exercise group and 34.1% of those in the sham exercise group reported that they had experienced back pain-related sick leave at 1-year follow-up. Of those who reported being on sick leave, 23.9% of the symptom-guided exercise group and 43% of the sham exercise group were on sick leave for more than 120 days.

Clinical Application & Conclusions:

Radicular leg pain patients were significantly improved in this study when they were provided either of the treatment options. Nonetheless, the differences between the groups favored the symptom guided exercise group on most outcome measures.

All of the patients had exhausted primary care treatment options, yet were still symptomatic. Therefore, a prudent spine care physician would incorporate this study’s symptom-guided exercise regimen in the care of their patients with radicular leg pain. Even if previous conservative treatment was unsuccessful, not all conservative treatments are the same (e.g., commonly used passive treatments), and it may be appropriate to provide these patients with this type of care before moving on to surgery.

The patients in this study had severe and prolonged symptoms which would typically have qualified them as surgical candidates. Even so, 89% of the patients reported being better or much better after 8 weeks of conservative treatment and 74% of the symptom-guided exercise group were back at work. These patients would not likely have fared any better had they opted for surgery, yet they would have been placed at risk for surgical side effects. (2)

Practitioners may use the results of this study to support evidence-based care for their patients with radicular leg pain using the intervention that was provided in the study. The authors made the treatment algorithm that was utilized available at the webpage given in the Methods section below.

Study Methods:

This was a prospective, single-blind, randomized and controlled clinical trial involving patients who were referred to the Back Centre Funen by general practitioners, rheumatologists and chiropractors after unsuccessful primary care treatment.

Inclusion criteria were as follows:
  • aged 18 to 65 years,
  • radicular pain of dermatomal distribution to the knee or below in 1 or both legs,
  • leg pain more than 3 on a 1-10 point scale, and
  • a duration of sciatica between 2 weeks and 1 year.
Exclusion criteria were as follows:
  • cauda equina syndrome,
  • previous back surgery,
  • spinal tumors,
  • pregnancy,
  • pending worker’s litigation,
  • a language other than Danish as their first language, and
  • inability to follow the rehabilitation protocol due to concomitant disease.
Patients were randomized to receive 1 of 2 types of exercise programs. One of the exercise programs was the treatment that was being tested, which was referred to as “symptom-guided exercises”. The other group of patients received a sham treatment referred to as “sham exercises.”

The symptom-guided exercises were back-related exercises consisting of:
  1. Directional end-range exercises,
  2. postural instructions based on the McKenzie method,
  3. instruction in stabilizing exercises for the transverse abdominis and multifidus muscles, and
  4. dynamic exercises for the outer layers of the abdominal wall and back extensors.
The symptom-guided exercises were customized to each patient and their particular condition according to a standardized algorithm in which different symptoms or responses to exercises determined the choice of exercises and instructions.

The sham exercises consisted of low-dose exercises to simulate an increase in systemic blood circulation, but they were not actually back-related.

Treatment was provided by physiotherapists and chiropractors and lasted for 8 weeks, with the patients receiving a minimum of 4 treatments and a maximum of 8 treatments. All patients received a handout consisting of a home exercise program.

Blinding of patients was not possible, so considerable effort went into educating patients about their exercise regimen, especially that both treatments were designed to improve their symptoms. Blinding of treatment providers was not possible, but they were instructed to be enthusiastic and promote the treatment that they were providing. On the other hand, the clinician who examined the patients at each follow-up point was blinded as to treatment allocation.

The primary outcome measures used in this study included the Danish version of the RMDQ, which was used to measure activity limitation, and the Low Back Pain Rating Scale, which measures low back and leg pain on a 0 to 10 scale. Secondary outcome measures comprised global improvement and the total number of neurological signs (e.g., muscle strength, tendon reflexes and sensory perception).

Study Strengths / Weaknesses:

This was a very well thought out and executed study with very few limitations.

The study’s results are enhanced by the fact that most patients thought that the sham exercise treatment would benefit them more than the symptom-guided exercise treatment. This makes the placebo effect less likely to have influenced the outcomes because patients’ belief that a treatment will help them typically boosts the associated effect. If the placebo effect was all that was at work in this study, the sham group would have improved more than the real exercise group, but they did not.

Even though blinding of patients was not possible, most patients were more confident that they would receive a benefit from the sham exercise. Thus, it is not likely that the lack of patient blinding negatively influenced the study’s results.

Treatment providers were not blinded, and even though they were instructed to be enthusiastic and promote the treatment that they were providing, it is possible that a degree of bias may have been introduced.

Additional References:

  1. Weber H, Holme I, Amlie E, et al. The natural course of acute sciatica with nerve root symptoms in a double-blind placebo-controlled trial evaluating the effect of piroxicam. Spine 1993;18:1433-8.
  2. Van den Hout WB , Peul WC , Koes BW . Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomized controlled trial. BMJ 2008;336:1351-4.