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

Primary Purpose

Chronic Low-back Pain, Muscle Atrophy, Diagnostic Imaging

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aquatic Therapy
Standard Care
Sponsored by
Concordia University, Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring low back pain, musculoskeletal rehabilitation, aquatic therapy, standard care, diagnostic imaging, muscle morphology, randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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

Sites / Locations

  • PERFORM CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aquatic Therapy

Standard Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).
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).
Percent change in multifidus muscle fatty infiltration in
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
Percent change in gluteal muscle fatty infiltration
Gluteal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 10, 2023
Last Updated
April 27, 2023
Sponsor
Concordia University, Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT05823857
Brief Title
Effect of an Aquatic Exercise Program in Patients With Chronic Low Back Pain
Official Title
Effect of Aquatic Exercise on Paraspinal and Gluteal Morphology and Function in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Concordia University, Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aquatic Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
Experimental
Arm Description
Standard care program including strengthening, flexibility, aerobic conditioning, modalities and manual mobilization techniques. Supervised 10-week program, 2 times a week.
Intervention Type
Other
Intervention Name(s)
Aquatic Therapy
Intervention Description
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
Intervention Name(s)
Standard Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in multifidus muscle size (cross-sectional area) in cm^2
Description
Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Time Frame
Baseline, 10-week
Title
Change in gluteal muscle size (cross-sectional area) in cm^2
Description
Gluteal muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI).
Time Frame
Baseline, 10-week
Title
Percent change in multifidus muscle fatty infiltration in
Description
Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
Time Frame
Baseline, 10-week
Title
Percent change in gluteal muscle fatty infiltration
Description
Gluteal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI).
Time Frame
Baseline, 10-week
Secondary Outcome Measure Information:
Title
Point score change in12-item Short Form Health Survey (SF-12)
Description
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).
Time Frame
Baseline, 10-week
Title
Point score change in Oswestry Low Back Pain Disability Index (ODI) score
Description
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.
Time Frame
Baseline, 10-week
Title
Point score change in Tampa Scale of Kinesiophobia (TSK)
Description
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.
Time Frame
Baseline, 10-week
Title
Point score change in The Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline, 10-week
Title
Point score change in The Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Baseline, 10-week
Title
Point score change in Insomnia Severity Index (ISI)
Description
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.
Time Frame
Baseline, 10-week
Title
Point score change in The International Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
Baseline, 10-week
Title
Point score change in Visual Numerical pain rating scale (NPR)
Description
The NPR for pain is a rating system from 0 to 10 with 0 being no pain and 10 worst pain imaginable.
Time Frame
Baseline, 10-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryse Fortin, PhD
Phone
514-848-2424
Ext
8642
Email
maryse.fortin@concordia.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryse Fortin, PhD
Organizational Affiliation
Concordia University, Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
PERFORM Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4B 1R6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent Rosenstein, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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

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