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Clinical Trials/NCT05823857
NCT05823857
Completed
Not Applicable

Effect of Aquatic Exercise on Paraspinal and Gluteal Morphology and Function in Patients With Chronic Low Back Pain

Concordia University, Montreal1 site in 1 country34 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low-back Pain
Sponsor
Concordia University, Montreal
Enrollment
34
Locations
1
Primary Endpoint
Change in multifidus muscle size (cross-sectional area) in cm^2
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
December 18, 2023
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Concordia University, Montreal
Responsible Party
Principal Investigator
Principal Investigator

Maryse Fortin

PhD, CAT(C)

Concordia University, Montreal

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Point score change in12-item Short Form Health Survey (SF-12)(Baseline, 10-week)
  • Point score change in The International Physical Activity Questionnaire (IPAQ)(Baseline, 10-week)
  • Point score change in Oswestry Low Back Pain Disability Index (ODI) score(Baseline, 10-week)
  • Point score change in Insomnia Severity Index (ISI)(Baseline, 10-week)
  • Point score change in The Hospital Anxiety and Depression Scale (HADS)(Baseline, 10-week)
  • Point score change in Visual Numerical pain rating scale (NPR)(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)

Study Sites (1)

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