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

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:

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain; Muscle Atrophy; Diagnostic Imaging; Exercise Therapy
• Intervention / Treatment: Other: Aquatic Therapy; Other: Standard Care

Detailed Description

Low back pain (LBP) is a well-recognized and significant public health concern. The healthcare-related cost for chronic LBP and social consequences are substantial for the society. In Canada, LBP related medical costs range between 6 and 12 billion dollars each year, and continue to increase. In addition, impairments in strength, flexibility, endurance, and obesity are well documented in individuals with chronic LBP. Exercise therapy is currently the most widely used form of conservative treatment for chronic LBP, with recent reviews supporting its effectiveness. Therefore, exercise therapy is recommended as a first-line treatment for people with chronic LBP, especially for the improvement of pain, quality of life, depression and disability/functional status. Given the body of evidence linking paraspinal muscle morphological changes (e.g. atrophy, fatty infiltration, asymmetry), gluteal functional changes (e.g., decreases in strength and muscle activation)and LBP, and lack of spinal stability due to impairments in the trunk and paraspinal muscles, many exercise interventions focus on activating of these muscles. Therefore, our objectives are 1) To investigate the effects of aquatic therapy versus standard care on a) paraspinal and gluteal muscles size, composition (e.g., fatty infiltration) and b) lumbar and gluteal muscles strength in individuals with chronic LBP. 2)To examine if aquatic therapy is more effective to improve pain, function and psychological factors (e.g., kinesiophobia, catastrophizing, anxiety, and depression) compared to standard care. 3)To evaluate the feasibility, adherence and satisfaction of using a digital application "play the pain" to monitor pain levels and the activities that participants used to cope with pain. We will be conducting a pilot randomized controlled trial. We will recruit a sample of 30 patients; 15 patients will be randomly allocated to each group (aquatic exercise and standard care). We will use convenience sampling to recruit participants from the PERFORM Centre clinic and media advertising. Inclusion criteria will include: 1) nonspecific chronic LBP (>3 months), 2) aged 18-64 years old, 3) currently seeking care for LBP, 4) English or French speakers, and 5) a score of "moderate" or "severe" on the modified Oswestry Low Back Pain Questionnaire. Both groups will receive 2 supervised sessions per week, for 10-weeks. All patients will undergo a spine and pelvic MRI exam as well as paraspinal and gluteal muscle strength test at baseline and at 10-weeks to assess the effect of each intervention on paraspinal and gluteal muscle size, composition, and strength. Similarly, self-reported questionnaires will be used to assess the effect of the interventions on pain, disability, and anxiety.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4B 1R6
      • PERFORM Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: Standard Care; Standard care program including strengthening, flexibility, aerobic conditioning, modalities and manual mobilization techniques. Supervised 10-week program, 2 times a week.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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.	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.	Baseline, 10-week

Collaborators and Investigators

• Sponsor: Concordia University, Montreal
• Investigators: Principal Investigator: Maryse Fortin, PhD, Concordia University, Montreal

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; low back pain; aquatic therapy; diagnostic imaging; muscle morphology; standard care; musculoskeletal rehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Back Pain; Low Back Pain; Muscular Atrophy
• Other Study ID Numbers: CCER-21-22-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No