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

March 28, 2012 updated by: Karen D. Kendall, Running Injury Clinic

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • Running Injury Clinic
        • Contact:
        • Principal Investigator:
          • Karen D Kendall, PhD Cand.
        • Principal Investigator:
          • Reed Ferber, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Local lumbopelvic stabilizers
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
Other Names:
  • Core stabilization exercises
  • Hip stabilization exercises
Experimental: Local lumbopelvic plus hip stabilizers
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
Other Names:
  • Core stabilization exercises
  • Hip stabilization exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Running Injury Clinic

Collaborators

Alberta Health services
WCB Alberta

Investigators

  • Principal Investigator: Karen D Kendall, MKin, Running Injury Clinic, Faculty of Kinesiology, University of Calgary
  • Study Director: Reed Ferber, PhD, Running Injury Clinic, Faculty of Kinesiology, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIC-WCB-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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