Chronic Low-back PainNCT05823857
Effect of an Aquatic Exercise Program in Patients With Chronic Low Back Pain
A study testing Aquatic Therapy in people with Chronic Low-back Pain and Muscle Atrophy, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
The goal of this pilot randomized controlled trial is to compare the effects of aquatic therapy versus standard care on paraspinal and gluteal morphology and function in individuals with chronic low back pain.The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain, Muscle Atrophy, Diagnostic Imaging
- What is being tested?
- Aquatic Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to 18 Dec 2023
- 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
- aged between 18 and 65 years old
- English or French speakers
- have a score of "moderate" or "severe" disability on the modified Oswestry Low Back Questionnaire
- do not currently engaged in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the trial).
Who cannot join
- evidence of nerve root compression or reflex motor signs deficits
- previous spinal surgery or vertebral fractures
- other major lumbar spine structural abnormalities
- comorbid health conditions that would prevent active participation in exercise programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aquatic Exercise on Paraspinal and Gluteal Morphology and Function in Patients With Chronic Low Back Pain
The goal of this pilot randomized controlled trial is to compare the effects of aquatic therapy versus standard care on paraspinal and gluteal morphology and function in individuals with chronic low back pain.The main questions it aims to answer are:
- What are the effects of aquatic therapy versus standard care on a) paraspinal and gluteal muscle size, composition (e.g., fatty infiltration) and b) lumbar and gluteal muscle strength in individuals with chronic LBP?
- Is aquatic therapy more effective than standard care to improve pain, function and psychological factors (e.g., kinesiophobia, catastrophizing, anxiety, and depression)?
- Is using a digital application "play the pain" feasible to monitor pain levels and the activities that participants used to cope with pain?
Participants will be assigned to either the aquatic therapy group or standard care group where they will undergo a 10-week intervention including two 60-minute session per week.
- Being tested
- Aquatic Therapy, Standard Care
- Keywords
- low back pain, musculoskeletal rehabilitation, aquatic therapy, standard care, diagnostic imaging, muscle morphology, randomized controlled trial
- Medical subject headings
- Muscular Atrophy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic TherapyOther
Participants in this experimental intervention group will perform trunk stabilization, which will be based on a variety of aquatic exercises in different positions, intended to activate the multifidus and transverse abdominis in a co-contraction. Additionally, hip exercises will be completed to promote the strengthening of the gluteus maximus, gluteus medius, and gluteus minimus muscles. The aim of these exercises is to enhance the strength and dynamic stability of the spine and its surrounding musculature in a functional and yet non-weight-bearing way. Each exercise will be performed 10 times while sustaining the muscles co-contraction for 5-10 seconds and will be progressed gradually. Each training session (60 minutes) will be supervised by a Certified Athletic Therapist and take place in the PERFORM AT Clinic/Swim Ex pool.
Standard CareOther
Participants in this experimental intervention group will receive the standard LBP treatment in the PERFORM Athletic Therapy clinic.Two Certified Athletic Therapists (AT) will be conducting the sessions. The ATs will complete a thorough assessment of the eligible participants with chronic LBP and administer a range of interventions including stretching, strengthening and stabilization exercise, aerobic conditioning, and manual mobilization techniques. Other modalities could include application of ice and heat, ultrasound, and transcutaneous electrical nerve stimulation (TENS).
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Therapy | Experimental | Aquatic exercise program including trunk stabilization, upper body, lower body strengthening and flexibility exercises and aerobic conditioning. Supervised 10-week program, 2 times a week. Receives: Other: Aquatic Therapy |
| Standard Care | Experimental | Standard care program including strengthening, flexibility, aerobic conditioning, modalities and manual mobilization techniques. Supervised 10-week program, 2 times a week. Receives: Other: Standard Care |
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) in cm^2
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Measured: Baseline, 10-week
Change in gluteal muscle size (cross-sectional area) in cm^2
Gluteal muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Measured: Baseline, 10-week
Percent change in multifidus muscle fatty infiltration in
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
Measured: Baseline, 10-week
Percent change in gluteal muscle fatty infiltration
Gluteal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
Measured: Baseline, 10-week
Secondary outcomes (8)
Point score 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 SF-12 Survey. The SF-12 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 a score 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, 10-week
Point score change in Oswestry Low Back Pain Disability Index (ODI) score
The ODI is used to measure the patient's level of disability in relation to LBP. It is a 10-item scale where each item is rated from 0-6. Higher scores are indicative of greater disability.
Measured: Baseline, 10-week
Point score 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, 10-week
Point score change in The Pain Catastrophizing Scale (PCS)
The PCS is a 13-item questionnaire that assesses an individual's level of catastrophizing. Each item is rated from 0-4 for a possible total of 52. Higher scores are indicative of a greater level of catastrophizing.
Measured: Baseline, 10-week
Point score 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. Higher scores are indicative of greater levels of anxiety and depression.
Measured: Baseline, 10-week
Point score 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. Higher scores are indicative of greater sleep disturbances.
Measured: Baseline, 10-week
Point score 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, 10-week
Point score change in Visual Numerical pain rating scale (NPR)
The NPR for pain is a rating system from 0 to 10 with 0 being no pain and 10 worst pain imaginable.
Measured: Baseline, 10-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Nov 2022
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Model description
- Pilot randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 34 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
- Investigators
- Maryse Fortin, PhD, Principal investigator, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823857
- Sponsor's protocol ID
- CCER-21-22-35
- Status last verified
- Nov 2024
- First submitted
- 10 Apr 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montpetit C, Vaillancourt N, Rosenstein B, Wesselink EO, Dover G, Weiss C, Papula LA, Melek A, Weber KA, Elliott JM, Fortin M. Effects of aquatic therapy vs. standard care on gluteal muscle morphology and function in individuals with chronic low back pain: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Apr 6;18(1):241. doi: 10.1186/s13102-026-01666-0.
PubMed 41943153Vaillancourt N, Montpetit C, Rosenstein B, Fortin M. Aquatic therapy compared to standard care for chronic low back pain: a randomized controlled trial. Pain Manag. 2026 Apr;16(4):309-321. doi: 10.1080/17581869.2026.2613633. Epub 2026 Jan 13.
PubMed 41527881Rosenstein B, Montpetit C, Vaillancourt N, Dover G, Khalini-Mahani N, Weiss C, Papula LA, Melek A, Fortin M. Effect of aquatic exercise versus standard care on paraspinal and gluteal muscles morphology in individuals with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2023 Dec 18;24(1):977. doi: 10.1186/s12891-023-07034-0.
PubMed 38110922
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 Aquatic Exercise on Paraspinal and Gluteal Morphology and Function in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05823857
- Acronym / sponsor ID
- CCER-21-22-35
- Keywords
- low back pain, musculoskeletal rehabilitation, aquatic therapy, standard care, diagnostic imaging, muscle morphology, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 21 Apr 2023 (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.
The goal of this pilot randomized controlled trial is to compare the effects of aquatic therapy versus standard care on paraspinal and gluteal morphology and function in individuals with chronic low back pain.The main questions it aims to answer are:
- What are the effects of aquatic therapy versus standard care on a) paraspinal and gluteal muscle size, composition (e.g., fatty infiltration) and b) lumbar and gluteal muscle strength in individuals with chronic LBP?
- Is aquatic therapy more effective than standard care to improve pain, function and psychological factors (e.g., kinesiophobia, catastrophizing, anxiety, and depression)?
- Is using a digital application "play the pain" feasible to monitor pain levels and the activities that participants used to cope with pain?
Participants will be assigned to either the aquatic therapy group or standard care group where they will undergo a 10-week intervention including two 60-minute session per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aquatic Therapy | Experimental | Other: Aquatic TherapyAquatic exercise program including trunk stabilization, upper body, lower body strengthening and flexibility exercises and aerobic conditioning. Supervised 10-week program, 2 times a week. |
| Standard Care | Experimental | Other: Standard CareStandard care program including strengthening, flexibility, aerobic conditioning, modalities and manual mobilization techniques. Supervised 10-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
- aged between 18 and 65 years old
- English or French speakers
- have a score of "moderate" or "severe" disability on the modified Oswestry Low Back Questionnaire
Key exclusion criteria (4 listed)
- evidence of nerve root compression or reflex motor signs deficits
- previous spinal surgery or vertebral fractures
- other major lumbar spine structural abnormalities
- comorbid health conditions that would prevent active participation in exercise programs
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 |
|---|---|---|
| Aquatic TherapyParticipants in this experimental intervention group will perform trunk stabilization, which will be based on a variety of aquatic exercises in different positions, intended to activate the multifidus and transverse abdominis in a co-contraction. Additionally, hip exercises will be completed to promote the strengthening of the gluteus maximus, gluteus medius, and gluteus minimus muscles. The aim of these exercises is to enhance the strength and dynamic stability of the spine and its surrounding musculature in a functional and yet non-weight-bearing way. Each exercise will be performed 10 times while sustaining the muscles co-contraction for 5-10 seconds and will be progressed gradually. Each training session (60 minutes) will be supervised by a Certified Athletic Therapist and take place in the PERFORM AT Clinic/Swim Ex pool. | Other | Aquatic Therapy |
| Standard CareParticipants in this experimental intervention group will receive the standard LBP treatment in the PERFORM Athletic Therapy clinic.Two Certified Athletic Therapists (AT) will be conducting the sessions. The ATs will complete a thorough assessment of the eligible participants with chronic LBP and administer a range of interventions including stretching, strengthening and stabilization exercise, aerobic conditioning, and manual mobilization techniques. Other modalities could include application of ice and heat, ultrasound, and transcutaneous electrical nerve stimulation (TENS). | Other | Standard Care |
Primary outcome
Change in multifidus muscle size (cross-sectional area) in cm^2
Time frame: Baseline, 10-week
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Change in gluteal muscle size (cross-sectional area) in cm^2
Time frame: Baseline, 10-week
Gluteal muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Percent change in multifidus muscle fatty infiltration in
Time frame: Baseline, 10-week
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
Percent change in gluteal muscle fatty infiltration
Time frame: Baseline, 10-week
Gluteal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
8 secondary outcomes
Point score change in12-item Short Form Health Survey (SF-12)
Time frame: Baseline, 10-week
Point score change in Oswestry Low Back Pain Disability Index (ODI) score
Time frame: Baseline, 10-week
Point score change in Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline, 10-week
Point score change in The Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 10-week
Point score change in The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 10-week
Point score change in Insomnia Severity Index (ISI)
Time frame: Baseline, 10-week
Point score change in The International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 10-week
Point score change in Visual Numerical pain rating scale (NPR)
Time frame: Baseline, 10-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.
- Derived from this study: PubMed 41943153Montpetit C, Vaillancourt N, Rosenstein B, Wesselink EO, Dover G, Weiss C, Papula LA, Melek A, Weber KA, Elliott JM, Fortin M. Effects of aquatic therapy vs. standard care on gluteal muscle morphology and function in individuals with chronic low back pain: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Apr 6;18(1):241. doi: 10.1186/s13102-026-01666-0.
- Derived from this study: PubMed 41527881Vaillancourt N, Montpetit C, Rosenstein B, Fortin M. Aquatic therapy compared to standard care for chronic low back pain: a randomized controlled trial. Pain Manag. 2026 Apr;16(4):309-321. doi: 10.1080/17581869.2026.2613633. Epub 2026 Jan 13.
- Derived from this study: PubMed 38110922Rosenstein B, Montpetit C, Vaillancourt N, Dover G, Khalini-Mahani N, Weiss C, Papula LA, Melek A, Fortin M. Effect of aquatic exercise versus standard care on paraspinal and gluteal muscles morphology in individuals with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2023 Dec 18;24(1):977. doi: 10.1186/s12891-023-07034-0.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
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.
Maryse Fortin, PhD principal investigator
Concordia University, Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Therapy in people with Chronic 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 4 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) in cm^2 (time frame: Baseline, 10-week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05823857, which also lists 3 linked publications.
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; AzTrials last refreshed its copy on 1 Nov 2026.