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

Low Back Pain, Mechanical Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01567566
• Other study ID #: RIC-WCB-001
• Status: Recruiting
• Phase: N/A
• First received: March 27, 2012
• Last updated: March 28, 2012
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: Running Injury Clinic
• Contact: Jill Baxter, BSc
• Phone: 403 220 7411
• Email: jbaxter[@]ucalgary.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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

Locations

Country	Name	City	State
Canada	Running Injury Clinic	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
Running Injury Clinic	Alberta Health Services, WCB Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks	No
Secondary	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	6 weeks	No
Secondary	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	6 weeks	No