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Spinal manipulation, epidural injections, and self-care for sciatica: a pilot study for a randomized clinical trial
Gert Bronfort1, Roni L Evans, Michele Maiers
1Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN 55431, USA. gbronfort@nwhealth.edu
Journal of Manipulative and Physiological Therapeutics
|October 29, 2004
Summary
This pilot study shows recruiting sciatica patients and their compliance is feasible for a larger trial. Key outcomes like Oswestry disability and leg pain improved significantly, indicating treatment effectiveness.
Area of Science:
- Neurology
- Clinical Trials
- Rehabilitation Medicine
Background:
- Sciatica, a common condition causing leg pain, necessitates effective treatment strategies.
- Evaluating treatment feasibility and patient compliance is crucial before large-scale clinical trials.
Purpose of the Study:
- To determine the feasibility of recruiting patients with sciatica.
- To assess patient compliance with different treatment modalities.
- To evaluate the responsiveness of key outcome measures for sciatica.
Main Methods:
- A pilot study involving 32 sciatica patients randomly assigned to spinal manipulation, epidural steroid injections, or self-care education.
- Outcome measures included Oswestry disability score, leg pain severity, and symptom bothersomeness.
- No between-group comparisons were planned due to the small sample size.
Main Results:
- Significant improvements were observed in Oswestry disability, leg pain severity, and symptom bothersomeness at 12 weeks (effect sizes 1.1-1.8).
- High patient satisfaction was reported, with 22/32 patients experiencing 75-100% improvement.
- Sustained improvements in leg pain and disability were noted at 52 weeks, with 15/32 patients reporting significant improvement.
Conclusions:
- Recruiting subacute and chronic sciatica patients for clinical trials is feasible.
- Patient compliance for a full-scale randomized clinical trial can be achieved.
- The chosen outcome measures are responsive to treatment changes in sciatica patients.