An Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific Low Back Pain

Overview

The primary objective of this study is to compare the efficacy of two different exercise programs for the reduction of pain and disability in a specific subgroup of NSLBP patients and aims to investigate the additive effect of hip stabilization exercises. The investigators hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (T2) will be more effective in reducing pain and disability in NSLBP patients compared to the local (segmental) stabilizer program (T1).

Full Title of Study: “The Effect of Hip Stabilizer Muscle Strengthening on Pain and Disability for Patients With Non-specific Low Back Pain: an Outcome-based Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2012

Detailed Description

The secondary objective of this study is to measure the changes in lumbopelvic and hip mechanics for both treatment groups following completion of the exercise programs. We hypothesize that there will be differences observed between groups following the 6wk rehabilitation programs, and that only the group completing the combined local (segmental) stabilizer and hip stabilizer strengthening program (T2) will demonstrate significant differences in mechanics compared to baseline testing.

Interventions

  • Other: exercise rehabilitation program
    • 6 week home based exercise rehabilitation program with 6 weekly supervised sessions using real time ultrasound as biofeedback to augment training in both treatment arms

Arms, Groups and Cohorts

  • Active Comparator: Local lumbopelvic stabilizers
  • Experimental: Local lumbopelvic plus hip stabilizers

Clinical Trial Outcome Measures

Primary Measures

  • Change in pain intensity measured by a 10cm visual analogue scale
    • Time Frame: 6 weeks
    • Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention

Secondary Measures

  • Change in biomechanical variables using an eight camera motion capture system
    • Time Frame: 6 weeks
    • Measures will be taken at baseline and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention
  • Change in disability score as measured by the Oswestry Disability Questionnaire
    • Time Frame: 6 weeks
    • Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention

Participating in This Clinical Trial

Inclusion Criteria

  • 18-65 years old
  • Unilateral or bilateral NSLBP symptoms for a minimum of 6 weeks
  • Current symptoms rated at least a 5/10 on a scaled from 0-10

Exclusion Criteria

  • Symptoms 'red flags' for underlying pathological conditions such as bowel and/or bladder problems, radicular symptoms, night pain
  • Scoliosis
  • Neurological impairment, discogenic pathology, vestibular disorder
  • Pregnancy or within 1 year of giving birth
  • Previous or ongoing complications from lower extremity injury or surgery in the past year
  • Previous surgery to the lumbar spine or hip
  • Use of any radiological interventions or injections such as prolotherapy, corticosteroid, or nerve block in the past 3 months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Running Injury Clinic
  • Collaborator
    • WCB Alberta
  • Provider of Information About this Clinical Study
    • Principal Investigator: Karen D. Kendall, PhD Candidate – Running Injury Clinic
  • Overall Official(s)
    • Karen D Kendall, MKin, Principal Investigator, Running Injury Clinic, Faculty of Kinesiology, University of Calgary
    • Reed Ferber, PhD, Study Director, Running Injury Clinic, Faculty of Kinesiology, University of Calgary
  • Overall Contact(s)
    • Jill Baxter, BSc, 403 220 7411, jbaxter@ucalgary.ca

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