Back to resultsAn Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific Low Back Pain (LBP-RCT)
Primary Purpose
Low Back Pain, Mechanical
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
exercise rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring home based daily exercise program, local lumbopelvic stabilizer muscles, hip stabilizer muscles, real time ultrasound imaging
Eligibility 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
Sites / Locations
- Running Injury ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Local lumbopelvic stabilizers
Local lumbopelvic plus hip stabilizers
Arm Description
Outcomes
Primary Outcome Measures
Change in pain intensity measured by a 10cm visual analogue scale
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
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
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
Full Information
NCT ID
NCT01567566
First Posted
March 27, 2012
Last Updated
March 28, 2012
Sponsor
Running Injury Clinic
Collaborators
WCB Alberta, Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT01567566
Brief Title
An Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific Low Back Pain
Acronym
LBP-RCT
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Running Injury Clinic
Collaborators
WCB Alberta, Alberta Health services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
home based daily exercise program, local lumbopelvic stabilizer muscles, hip stabilizer muscles, real time ultrasound imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local lumbopelvic stabilizers
Arm Type
Active Comparator
Arm Title
Local lumbopelvic plus hip stabilizers
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
exercise rehabilitation program
Other Intervention Name(s)
Core stabilization exercises, Hip stabilization exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in pain intensity measured by a 10cm visual analogue scale
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in biomechanical variables using an eight camera motion capture system
Description
Measures will be taken at baseline and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention
Time Frame
6 weeks
Title
Change in disability score as measured by the Oswestry Disability Questionnaire
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Baxter, BSc
Phone
403 220 7411
Email
jbaxter@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen D Kendall, MKin
Organizational Affiliation
Running Injury Clinic, Faculty of Kinesiology, University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reed Ferber, PhD
Organizational Affiliation
Running Injury Clinic, Faculty of Kinesiology, University of Calgary
Official's Role
Study Director
Facility Information:
Facility Name
Running Injury Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Baxter, BSc
Phone
403 220 7411
Email
jbaxter@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Karen D Kendall, PhD Cand.
First Name & Middle Initial & Last Name & Degree
Reed Ferber, PhD
12. IPD Sharing Statement
Learn more about this trial
An Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific Low Back Pain
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