Effect of an Aquatic Exercise Program in Patients With Chronic Low Back Pain

NCT05823857 | Completed

• 1 other identifier: CCER-21-22-35
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 1.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?
2. 2.Is aquatic therapy more effective than standard care to improve pain, function and psychological factors (e.g., kinesiophobia, catastrophizing, anxiety, and depression)?
3. 3.Is using a digital application "play the pain" feasible to monitor pain levels and the activities that participants used to cope with pain?

Conditions

Chronic Low-back Pain; Muscle Atrophy; Diagnostic Imaging; Exercise Therapy

Keywords

low back pain; musculoskeletal rehabilitation; aquatic therapy; standard care; diagnostic imaging; muscle morphology; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  Baseline, 10-week

• Percent change in gluteal muscle fatty infiltration

  Gluteal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).

  Baseline, 10-week

Secondary Outcomes (8)

• Point score change in12-item Short Form Health Survey (SF-12)

  Baseline, 10-week

• Point score change in Oswestry Low Back Pain Disability Index (ODI) score

  Baseline, 10-week

• Point score change in Tampa Scale of Kinesiophobia (TSK)

  Baseline, 10-week

• Point score change in The Pain Catastrophizing Scale (PCS)

  Baseline, 10-week

• Point score change in The Hospital Anxiety and Depression Scale (HADS)

  Baseline, 10-week

Study Arms (2)

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.

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.

Other: Standard Care

Interventions

Aquatic Therapy OTHER

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.

Aquatic Therapy

Standard Care OTHER

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).

Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Concordia University, Montreal: lead

Study Sites (1)

PERFORM Centre

Montreal, Quebec, H4B 1R6, Canada

Location

Related Publications (2)

• Vaillancourt 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 Jan 13:1-13. doi: 10.1080/17581869.2026.2613633. Online ahead of print.

  PMID: 41527881 DERIVED

• Rosenstein 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.

  PMID: 38110922 DERIVED

MeSH Terms

Conditions

Muscular Atrophy; Low Back Pain

Interventions

Aquatic Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Pain

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maryse Fortin, PhD

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, CAT(C)

Model Details: Pilot randomized controlled trial

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: November 1, 2022
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: July 1, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)