Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain
- Conditions
- Exercise TherapyMuscle AtrophyLow Back PainDiagnostic Imaging
- Interventions
- Other: Targeted exercise programOther: General exercise program
- Registration Number
- NCT04257253
- Lead Sponsor
- Concordia University, Montreal
- Brief Summary
This study evaluates the effect of a supervised exercise program on paraspinal muscle morphology and function, as well as disability/function in patients with non-specific chronic low back pain. Half of the participants will do a targeted paraspinal muscle exercise program, while the other half will do a general exercise program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- chronic nonspecific LBP (>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain
- currently seeking care for LBP
- between 18 and 60 years of age
- English or French speaker
- score of "moderate" or "severe" disability on the ODI questionnaire
- do not currently engage in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the study).
- evidence of nerve root compression or reflex motor signs deficits (e.g. weakness, reflex changes, or sensory loss with same spinal nerve)
- previous spinal surgery or vertebral fractures
- other major lumbar spine structural abnormalities (e.g. spondylolysis, spondylolisthesis, or lumbar scoliosis >10°)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Targeted exercise program Targeted exercise program Targeted motor control and isolated lumbar extensor strengthening exercises. Supervised 12-week program, 2 times a week. General exercise program General exercise program General exercise program including upper body and lower body strengthening and flexibility exercises. Supervised 12-week program, 2 times a week.
- Primary Outcome Measures
Name Time Method Change in multifidus muscle size (cross-sectional area) Baseline, 6-week, 12-week Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.
Change in multifidus muscle fatty infiltration Baseline, 6-week, 12-week Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.
- Secondary Outcome Measures
Name Time Method Change in Oswestry Low Back Pain Disability Index (ODI) Baseline, 6-week, 12-week, 24-week The ODI is used to measure the patient's level of disability in relation to LBP. It is a 10-item scale in which each item is rated from 0-6. Higher scores are indicative of greater disability.
Change in Insomnia Severity Index (ISI) Baseline, 6-week, 12-week, 24-week The ISI is a 7-item questionnaire used to assess sleep disturbances. Each item is rated from 0 to 4 and the total score is added. The higher the score, the greater the level of sleep disturbances.
Change in12-item Short Form Health Survey (SF-12) Baseline, 6-week, 12-week, 24-week The 12-item Short Form Health Survey (SF-12) is the condensed form of the previous 36-item Short Form Health Survey and is used to assess health-related quality of life.The 12-item survey consists of 8 domains that assess both physical and mental health composite scores (PCS and MCS). While the SF-12 is weighted and summed to provide an interpretable scale for both the PCS and MCS. The score of the 12 questions can range from 0 (worst level of health) to 100 (highest level of health).
Change in Tampa Scale of Kinesiophobia (TSK) Baseline, 6-week, 12-week, 24-week The TSK measures pain-related fear in an individual through a 13-item scale. The scores range between 17 and 68 with increasing scores indicating a greater level of kinesiophobia.
Change in The Pain Catastrophizing Scale (PCS) Baseline, 6-week, 12-week, 24-week The PCS is a 13-item questionnaire that assesses the participant's level of catastrophizing. Each item is rated from 0-4 for a possible total of 52. The higher the score, the greater the level of catastrophizing.
Change in The International Physical Activity Questionnaire (IPAQ) Baseline, 6-week, 12-week, 24-week The IPAQ is a self-reported log of metabolic equivalent (MET)-minutes per week. The level of physical activity is rated either vigorous, moderate, walking and sitting and must be assigned to the right category. The number of minutes per category is then added up and assessed.
Change in Visual Numerical pain rating scale (NPR) Baseline, 6-week, 12-week, 24-week The NRP for pain is a rating system from 0 to 10 with 0 being no pain and 10 worst pain imaginable.
Change in paraspinal muscle size (cross-sectional area) Baseline, 6-week, 12-week Paraspinal muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.
Change in paraspinal muscle fatty infiltration Baseline, 6-week, 12-week Paraspinal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.
Change in The Hospital Anxiety and Depression Scale (HADS) Baseline, 6-week, 12-week, 24-week The HADS is a 14-item questionnaire used to assess a patient's level of depression and anxiety. Each item is rated from 0-3 with either depression or anxiety having scores between 0 and 21, with 21 being the highest level possible.
Change in lumbar extensor muscle strength Baseline, 6-week, 12-week lumbar extensor muscle strength will be assessed using a MedX Lumbar Isokinetic Dynamometer.
Change in multifidus muscle function (% thickness change) Baseline, 6-week, 12-week Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via contralateral arm lifts will be assessed by ultrasound.
Trial Locations
- Locations (1)
PERFORM Centre
🇨🇦Montréal, Quebec, Canada