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

NCT ID: NCT05823857

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-12-18

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. 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. Is aquatic therapy more effective than standard care to improve pain, function and psychological factors (e.g., kinesiophobia, catastrophizing, anxiety, and depression)?

3. 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aquatic Therapy

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.

Group Type: EXPERIMENTAL

Aquatic Therapy

Intervention Type: 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.

Standard Care

Standard care program including strengthening, flexibility, aerobic conditioning, modalities and manual mobilization techniques. Supervised 10-week program, 2 times a week.

Group Type: EXPERIMENTAL

Standard Care

Intervention Type: 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).

Interventions

Aquatic Therapy

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.

Intervention Type: OTHER

Standard Care

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).

Intervention Type: OTHER

Eligibility Criteria

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. aged between 18 and 65 years old

4. English or French speakers

5. have a score of "moderate" or "severe" disability on the modified Oswestry Low Back Questionnaire

6. do not currently engaged in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the trial).

Exclusion Criteria

1. evidence of nerve root compression or reflex motor signs deficits

2. previous spinal surgery or vertebral fractures

3. other major lumbar spine structural abnormalities

4. comorbid health conditions that would prevent active participation in exercise programs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Concordia University, Montreal

OTHER

Sponsor Role: lead

Responsible Party

Maryse Fortin

PhD, CAT(C)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maryse Fortin, PhD

Role: PRINCIPAL_INVESTIGATOR

Concordia University, Montreal

Locations

PERFORM Centre

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38110922 (View on PubMed)

Other Identifiers

CCER-21-22-35

Identifier Type: -

Identifier Source: org_study_id