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Chiropractic and Self-care for Back-Related Leg Pain

NCT00494065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2014-01-31

No results posted yet for this study

Summary

The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.

Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.

Conditions

  • Sub-acute and Chronic Back-related Leg Pain

Interventions

OTHER

Home exercise

Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.

OTHER

Chiropractic Spinal Manipulative Therapy + Home exercise

The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.

Sponsors & Collaborators

Principal Investigators

  • Gert Bronfort, DC, PhD · Northwestern Health Sciences University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00494065 on ClinicalTrials.gov