Clinical trial NCT05823857: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in multifidus muscle size (cross-sectional area) in cm^2
timeFrame: Baseline, 10-week
measure: Change in gluteal muscle size (cross-sectional area) in cm^2
timeFrame: Baseline, 10-week
measure: Percent change in multifidus muscle fatty infiltration in
timeFrame: Baseline, 10-week
measure: Percent change in gluteal muscle fatty infiltration
timeFrame: Baseline, 10-week
Secondary outcomes:
measure: Point score change in12-item Short Form Health Survey (SF-12)
timeFrame: Baseline, 10-week
measure: Point score change in Oswestry Low Back Pain Disability Index (ODI) score
timeFrame: Baseline, 10-week
measure: Point score change in Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline, 10-week
measure: Point score change in The Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 10-week
measure: Point score change in The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 10-week
measure: Point score change in Insomnia Severity Index (ISI)
timeFrame: Baseline, 10-week
measure: Point score change in The International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 10-week
measure: Point score change in Visual Numerical pain rating scale (NPR)
timeFrame: Baseline, 10-week
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: PERFORM Centre
state: Quebec
Study officials:
affiliation: Concordia University, Montreal
name: Maryse Fortin, PhD
role: PRINCIPAL_INVESTIGATOR
References: