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Related Experiment Video

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Nonoperative treatments for sciatica: a pilot study for a randomized clinical trial.

G Bronfort1, R L Evans, A V Anderson

  • 1Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN 55431, USA. gbronfort@nwhealth.edu

Journal of Manipulative and Physiological Therapeutics
|October 26, 2000
PubMed
Summary

Recruiting patients with recent sciatica (2-12 weeks) for large trials is not feasible. However, chronic sciatica patients are willing to participate, and pilot study protocols are viable.

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Area of Science:

  • Clinical Trials
  • Health Services Research
  • Pain Management

Background:

  • Sciatica, characterized by low back-related radiating leg pain, affects many individuals.
  • Previous research indicates varied treatment outcomes, necessitating further investigation.
  • Pilot studies are crucial for assessing the feasibility of large-scale clinical trials.

Purpose of the Study:

  • To evaluate the feasibility of patient recruitment for a full-scale sciatica trial.
  • To assess patient and clinician adherence to study protocols.
  • To determine the usability of data collection instruments for cost-effectiveness analysis and obtain variability estimates for sample-size calculations.

Main Methods:

  • A prospective, observer-blinded, pilot randomized clinical trial.
  • Participants aged 20-65 with sciatica were recruited from chiropractic and medical clinics.
  • Data on pain, disability, medication use, and healthcare utilization were collected via self-report questionnaires at baseline and 3/12 weeks.

Main Results:

  • Screening 706 individuals revealed over 90% did not meet eligibility criteria, primarily due to symptom duration >3 months.
  • Twenty patients were randomized; all groups showed significant improvement (50-84%) in patient-rated outcomes.
  • Effect sizes ranged from 0.8 to 2.2, with leg symptom bothersomeness being the most responsive outcome.

Conclusions:

  • Recruitment for a full-scale trial of short-duration sciatica (2-12 weeks) is not feasible with current methods.
  • Patients with chronic sciatica are willing to participate, and pilot study protocols demonstrate high patient and provider compliance.
  • A second pilot study focusing on longer-duration sciatica (>4 weeks) is planned, with modifications to the intervention groups.