Clinical trial NCT04257253: Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain
Official title: Effect of a Supervised Exercise Program on Paraspinal Muscle Morphology and Function in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Muscle Atrophy
Diagnostic Imaging
Exercise Therapy
Keywords: low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 50
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: 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.


Eligibility criteria: Inclusion Criteria:

1. chronic nonspecific LBP (\>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain
2. currently seeking care for LBP
3. between 18 and 60 years of age
4. English or French speaker
5. score of "moderate" or "severe" disability on the ODI questionnaire
6. do not currently engage in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the study).

Exclusion Criteria:

1. evidence of nerve root compression or reflex motor signs deficits (e.g. weakness, reflex changes, or sensory loss with same spinal nerve)
2. previous spinal surgery or vertebral fractures
3. other major lumbar spine structural abnormalities (e.g. spondylolysis, spondylolisthesis, or lumbar scoliosis \>10°)

Primary outcomes:
measure: Change in multifidus muscle size (cross-sectional area)
timeFrame: Baseline, 6-week, 12-week
measure: Change in multifidus muscle fatty infiltration
timeFrame: Baseline, 6-week, 12-week
Secondary outcomes:
measure: Change in12-item Short Form Health Survey (SF-12)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in Oswestry Low Back Pain Disability Index (ODI)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in The International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in Visual Numerical pain rating scale (NPR)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in The Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline, 6-week, 12-week, 24-week
measure: Change in paraspinal muscle size (cross-sectional area)
timeFrame: Baseline, 6-week, 12-week
measure: Change in paraspinal muscle fatty infiltration
timeFrame: Baseline, 6-week, 12-week
measure: Change in multifidus muscle function (% thickness change)
timeFrame: Baseline, 6-week, 12-week
measure: Change in lumbar extensor muscle strength
timeFrame: Baseline, 6-week, 12-week
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: PERFORM Centre
state: Quebec
Study officials:
References: