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

Citation
G. Bronfort et al., Nonoperative treatments for sciatica: A pilot study for a randomized clinical trial, J MANIP PHY, 23(8), 2000, pp. 536-544
Citations number
72
Categorie Soggetti
Ortopedics, Rehabilitation & Sport Medicine
Journal title
JOURNAL OF MANIPULATIVE AND PHYSIOLOGICAL THERAPEUTICS
ISSN journal
01614754 → ACNP
Volume
23
Issue
8
Year of publication
2000
Pages
536 - 544
Database
ISI
SICI code
0161-4754(200010)23:8<536:NTFSAP>2.0.ZU;2-E
Abstract
Objectives: To assess the feasibility of patient recruitment, the ability o f patients and clinicians to comply with study protocols, and the use of da ta collection instruments to collect cost-effectiveness data, and to obtain variability estimates for sample-size calculations for a full-scale trial. Study Design: Prospective, observer-blinded, pilot randomized clinical tria l. Setting: Primary contact chiropractic and medical clinics. Patients: Ages 20 to 65 years, with low back-related radiating leg pain (sc iatica). Outcome Measures: Self-report questionnaires were administered at baseline and 3 and 12 weeks after randomization. The measures included leg and back pain severity, frequency and bothersomeness of symptoms, leg/back disabilit y, medication use, global improvement, satisfaction and health care utiliza tion. Interventions: Medical care, chiropractic care, and epidural steroid inject ions. Results: A total of 706 persons were screened by phone to deter mine initia l eligibility. Of these, over 90% of those persons contacted did not meet t he entrance criteria. The most common reason for disqualification was that the duration of the complaint was longer than 3 months. Twenty patients wer e randomized into the study. All 3 groups showed substantial improvements i n the main patient-rated outcomes at the end of the 12-week intervention ph ase. For leg pain, back pain, frequency and bothersomeness of leg symptoms, and Roland-Morris disability score, the percent improvement varied from 50 % to 84%, and the corresponding effect sizes ranged from 0.8 to 2.2. Bother someness of leg symptoms was the most responsive outcome associated with th e largest magnitude of effect size. All within-group changes from baseline were statistically significant (P <.01). No between-group comparisons were planned or performed because of the insufficient sample size and high risk of committing type I and type II errors. Conclusions: Pilot studies such as these are important for the determinatio n of the feasibility of conducting costly, larger scale trials. Recruitment for a full-scale study of sciatica of 1 to 12 weeks duration is not feasib le, given the methods used in this pilot study. Our results do indicate, ho wever, that there are substantial numbers of patients with sciatica more ch ronic in nature who would be interested in participating in a similar study . In addition, collaboration with a local health maintenance organization w ould likely facilitate clinician referrals and optimize the recruitment pro cess. Patient and provider compliance was high in the pilot study, which in dicates that most study protocols are feasible. Additionally, we were able to collect complete outcomes data, including those regarding health care us e. A suggested modification by investigators and outside consultants has re sulted in the replacement of the medication group with a minimal interventi on control group tie, self-care advice). As a result, a second pilot study of patients with sciatica of more than 1 weeks duration has been planned be fore a full-scale trial is attempted.