Index to Chiropractic Literature
Index to Chiropractic Literature
My ICL     Sign In
Monday, May 17, 2021
Index to Chiropractic LiteratureIndex to Chiropractic LiteratureIndex to Chiropractic Literature
Share:


For best results switch to Advanced Search.
Article Detail
Return to Search Results
ID 14798
  Title Nonoperative treatments for sciatica: a pilot study for a randomized clinical trial
URL http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11050610
Journal J Manipulative Physiol Ther. 2000 Oct;23(8):536-544
Author(s)
Subject(s)
Peer Review Yes
Publication Type Randomized Controlled Trial
Abstract/Notes OBJECTIVES: To assess the feasibility of patient recruitment, the ability of patients and clinicians to comply with study protocols, and the use of data 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 trial.

SETTING: Primary contact chiropractic and medical clinics.

PATIENTS: Ages 20 to 65 years, with low back-related radiating leg pain (sciatica).

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 disability, medication use, global improvement, satisfaction, and health care utilization.

INTERVENTIONS: Medical care, chiropractic care, and epidural steroid injections.

RESULTS: A total of 706 persons were screened by phone to determine initial eligibility. Of these, over 90% of those persons contacted did not meet the entrance criteria. The most common reason for disqualification was that the duration of the complaint was longer than 3 months. Twenty patients were randomized into the study. All 3 groups showed substantial improvements in the main patient-rated outcomes at the end of the 12-week intervention phase. 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. Bothersomeness of leg symptoms was the most responsive outcome associated with the 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 determination of the feasibility of conducting costly, larger scale trials. Recruitment for a full-scale study of sciatica of 2 to 12 weeks duration is not feasible, given the methods used in this pilot study. Our results do indicate, however, that there are substantial numbers of patients with sciatica more chronic in nature who would be interested in participating in a similar study. In addition, collaboration with a local health maintenance organization would likely facilitate clinician referrals and optimize the recruitment process. Patient and provider compliance was high in the pilot study, which indicates that most study protocols are feasible. Additionally, we were able to collect complete outcomes data, including those regarding health care use. A suggested modification by investigators and outside consultants has resulted in the replacement of the medication group with a minimal intervention control group (ie, self-care advice). As a result, a second pilot study of patients with sciatica of more than 4 weeks duration has been planned before a full-scale trial is attempted.

Click on the above link for the PubMed record for this article; full text by subscription.

   Text (Citation) Tagged (Export) Excel
 
Email To
Subject
 Message
Format
HTML Text     Excel



To use this feature you must register a personal account in My ICL. Registration is free! In My ICL you can save your ICL searches in My Searches, and you can save search results in My Collections. Be sure to use the Held Citations feature to collect citations from an entire search session. Read more search tips.

Sign Into Existing My ICL Account    |    Register A New My ICL Account
Search Tips
  • Enclose phrases in "quotation marks".  Examples: "low back pain", "evidence-based"
  • Retrieve all forms of a word with an asterisk*, also called a wildcard or truncation.  Example: chiropract* retrieves chiropractic, chiropractor, chiropractors
  • Register an account in My ICL to save search histories (My Searches) and collections of records (My Collections)
Advanced Search Tips