Low Back PainNCT04257253
Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain
A study testing Targeted exercise program and General exercise program in people with Low Back Pain and Muscle Atrophy, run by Concordia University, Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Muscle Atrophy, Diagnostic Imaging
- What is being tested?
- Targeted exercise program and General exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2020to 11 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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°)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Low Back Pain, Muscle Atrophy, Diagnostic Imaging, Exercise Therapy
- Being tested
- Targeted exercise program, General exercise program
- Keywords
- low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial
- Medical subject headings
- Low Back Pain, Muscular Atrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted exercise programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted exercise program | Experimental | Targeted motor control and isolated lumbar extensor strengthening exercises. Supervised 12-week program, 2 times a week. Receives: Other: Targeted exercise program |
| General exercise program | Active comparator | General exercise program including upper body and lower body strengthening and flexibility exercises. Supervised 12-week program, 2 times a week. Receives: Other: General exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6-week, 12-week
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.
Measured: Baseline, 6-week, 12-week
Secondary outcomes (12)
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).
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week, 24-week
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.
Measured: Baseline, 6-week, 12-week
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.
Measured: Baseline, 6-week, 12-week
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.
Measured: Baseline, 6-week, 12-week
Change in lumbar extensor muscle strength
lumbar extensor muscle strength will be assessed using a MedX Lumbar Isokinetic Dynamometer.
Measured: Baseline, 6-week, 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Dec 2020
- Primary completion13 Oct 2021
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryse Fortin, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257253
- Sponsor's protocol ID
- CCER19-20-09
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2020
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04257253
- Acronym / sponsor ID
- CCER19-20-09
- Conditions
- Low Back Pain, Muscle Atrophy, Diagnostic Imaging, Exercise Therapy
- Keywords
- low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted exercise program | Experimental | Other: Targeted exercise programTargeted motor control and isolated lumbar extensor strengthening exercises. Supervised 12-week program, 2 times a week. |
| General exercise program | Active comparator | Other: General exercise programGeneral exercise program including upper body and lower body strengthening and flexibility exercises. Supervised 12-week program, 2 times a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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°)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted exercise programParticipants 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. | Other | Targeted exercise program |
| General exercise programParticipants 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. | Other | General exercise program |
Primary outcome
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.
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.
12 secondary outcomes
Change in12-item Short Form Health Survey (SF-12)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in Oswestry Low Back Pain Disability Index (ODI)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in The International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in Visual Numerical pain rating scale (NPR)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in The Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in Insomnia Severity Index (ISI)
Time frame: Baseline, 6-week, 12-week, 24-week
Change in paraspinal muscle size (cross-sectional area)
Time frame: Baseline, 6-week, 12-week
Change in paraspinal muscle fatty infiltration
Time frame: Baseline, 6-week, 12-week
Change in multifidus muscle function (% thickness change)
Time frame: Baseline, 6-week, 12-week
Change in lumbar extensor muscle strength
Time frame: Baseline, 6-week, 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted exercise program and General exercise program in people with Low Back Pain and Muscle Atrophy, run by Concordia University, Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in multifidus muscle size (cross-sectional area) (time frame: Baseline, 6-week, 12-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.