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CompletedNCT04257253Updated Jul 1, 2025

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

An interventional study of Targeted exercise program and General exercise program in Low Back Pain, Muscle Atrophy and Diagnostic Imaging, sponsored by Concordia University, Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Concordia University, Montreal · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Low Back Pain
  • Muscle Atrophy
  • Diagnostic Imaging
  • Exercise Therapy

Keywords

  • low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial
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In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Concordia University, Montreal is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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°)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Targeted exercise program

    Targeted motor control and isolated lumbar extensor strengthening exercises. Supervised 12-week program, 2 times a week.

    Other: Targeted exercise program

  • Active comparator
    General exercise program

    General exercise program including upper body and lower body strengthening and flexibility exercises. Supervised 12-week program, 2 times a week.

    Other: General exercise program

Interventions

  • OtherTargeted exercise program

    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.

  • OtherGeneral exercise program

    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.

06

What researchers measure

Primary outcomes

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

    Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.

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

  2. Change in multifidus muscle fatty infiltration

    Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.

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

Secondary outcomes

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

    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).

    Time frame: Baseline, 6-week, 12-week, 24-week

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

    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.

    Time frame: Baseline, 6-week, 12-week, 24-week

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

    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.

    Time frame: Baseline, 6-week, 12-week, 24-week

  4. Change in Tampa Scale of Kinesiophobia (TSK)

    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.

    Time frame: Baseline, 6-week, 12-week, 24-week

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

    The NRP for pain is a rating system from 0 to 10 with 0 being no pain and 10 worst pain imaginable.

    Time frame: Baseline, 6-week, 12-week, 24-week

  6. Change in The Pain Catastrophizing Scale (PCS)

    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.

    Time frame: Baseline, 6-week, 12-week, 24-week

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

    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.

    Time frame: Baseline, 6-week, 12-week, 24-week

  8. Change in Insomnia Severity Index (ISI)

    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.

    Time frame: Baseline, 6-week, 12-week, 24-week

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

    Paraspinal muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.

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

  10. Change in paraspinal muscle fatty infiltration

    Paraspinal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.

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

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

    Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via contralateral arm lifts will be assessed by ultrasound.

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

  12. Change in lumbar extensor muscle strength

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

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

07

Study locations

1 site
  • PERFORM Centre
    Montreal, Quebec H4B1R6, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04257253
Lead sponsor
Concordia University, Montreal
Responsible party
Maryse Fortin (Assistant Professor, Concordia University, Montreal) — Principal investigator
First posted
Feb 5, 2020
Start date
Dec 1, 2020
Primary completion
Oct 13, 2021
Completion
Jan 11, 2022
Last update
Jul 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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