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Completed

NCT Number: NCT04257253

Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain Atrophy Back Pain Behavior Diagnostic Imaging Exercise Therapy Motor Activity Muscle Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PERFORM Centre

Montreal, Quebec, H4B1R6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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°)

Treatment and study plan

Targeted exercise program

Other

Participants in this experimental intervention group will perform a combination of motor control and isolated lumbar extensor strenghtening exercises. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.

General exercise program

Other

Participants in this active intervention group will perform a generalized exercise program comprising upper-body and lower-body and hip strengthening exercises, as well as flexibility. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.

Primary outcomes

  1. Change in multifidus muscle size (cross-sectional area)

    Time frame: 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.

  2. Change in multifidus muscle fatty infiltration

    Time frame: 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 outcomes

  1. Change in12-item Short Form Health Survey (SF-12)

    Time frame: 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).

  2. Change in Oswestry Low Back Pain Disability Index (ODI)

    Time frame: 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.

  3. Change in The International Physical Activity Questionnaire (IPAQ)

    Time frame: 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.

  4. Change in Tampa Scale of Kinesiophobia (TSK)

    Time frame: 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.

  5. Change in Visual Numerical pain rating scale (NPR)

    Time frame: 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.

  6. Change in The Pain Catastrophizing Scale (PCS)

    Time frame: 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.

  7. Change in The Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  8. Change in Insomnia Severity Index (ISI)

    Time frame: 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.

  9. Change in paraspinal muscle size (cross-sectional area)

    Time frame: 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.

  10. Change in paraspinal muscle fatty infiltration

    Time frame: 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.

  11. Change in multifidus muscle function (% thickness change)

    Time frame: 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.

  12. Change in lumbar extensor muscle strength

    Time frame: Baseline, 6-week, 12-week

    lumbar extensor muscle strength will be assessed using a MedX Lumbar Isokinetic Dynamometer.

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Registry information

Official study title

Effect of a Supervised Exercise Program on Paraspinal Muscle Morphology and Function in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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