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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Running Injury Clinic.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
WCB Alberta
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Karen D. Kendall, Running Injury Clinic
ClinicalTrials.gov Identifier:
NCT01567566
First received: March 27, 2012
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention
Low Back Pain, Mechanical
Other: exercise rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Running Injury Clinic:

Primary Outcome Measures:
  • Change in pain intensity measured by a 10cm visual analogue scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in biomechanical variables using an eight camera motion capture system [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567566

Contacts
Contact: Jill Baxter, BSc 403 220 7411 jbaxter@ucalgary.ca

Locations
Canada, Alberta
Running Injury Clinic Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Jill Baxter, BSc    403 220 7411    jbaxter@ucalgary.ca   
Principal Investigator: Karen D Kendall, PhD Cand.         
Principal Investigator: Reed Ferber, PhD         
Sponsors and Collaborators
Running Injury Clinic
WCB Alberta
AHS Cancer Control 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
  More Information

No publications provided

Responsible Party: Karen D. Kendall, PhD Candidate, Running Injury Clinic
ClinicalTrials.gov Identifier: NCT01567566     History of Changes
Other Study ID Numbers: RIC-WCB-001
Study First Received: March 27, 2012
Last Updated: March 28, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Running Injury Clinic:
home based daily exercise program
local lumbopelvic stabilizer muscles
hip stabilizer muscles
real time ultrasound imaging

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014