Clinical trial NCT01567566: An Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific Low Back Pain
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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: home based daily exercise program
local lumbopelvic stabilizer muscles
hip stabilizer muscles
real time ultrasound imaging
Lead sponsor: Running Injury Clinic
Sponsor class: OTHER
Collaborators: name: WCB Alberta
name: Alberta Health services
First posted: 2012-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain intensity measured by a 10cm visual analogue scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in biomechanical variables using an eight camera motion capture system
timeFrame: 6 weeks
measure: Change in disability score as measured by the Oswestry Disability Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Running Injury Clinic
state: Alberta
Study officials:
affiliation: Running Injury Clinic, Faculty of Kinesiology, University of Calgary
name: Karen D Kendall, MKin
role: PRINCIPAL_INVESTIGATOR
affiliation: Running Injury Clinic, Faculty of Kinesiology, University of Calgary
name: Reed Ferber, PhD
role: STUDY_DIRECTOR
References: