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Aquatic Exercise Program for Chronic Low Back Pain

N/A

Recruiting

Led By Maryse Fortin, PhD

Research Sponsored by Concordia University, Montreal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 18 and 65 years old

Have a score of 'moderate' or 'severe' disability on the modified Oswestry Low Back Questionnaire

Must not have

Previous spinal surgery or vertebral fractures

Evidence of nerve root compression or reflex motor signs deficits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10-week

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare effects of aquatic therapy & standard care on paraspinal & gluteal muscle size, composition & strength in people with chronic low back pain. Effects on pain, function & psychological factors will also be compared. Two 60-min sessions/week for 10 weeks.

Who is the study for?

This trial is for adults aged 18-65 with chronic low back pain who are currently seeking care and have moderate to severe disability according to a specific questionnaire. They should not be in lower back-specific training, have nerve root compression, previous spinal surgery, major spine abnormalities, or health conditions preventing exercise.

What is being tested?

The study compares aquatic therapy with standard care over a 10-week period to see which is better at improving muscle size and strength in the back and glutes, reducing pain, enhancing function and psychological well-being. Participants will attend two sessions per week.

What are the potential side effects?

Aquatic therapy may cause muscle soreness or fatigue initially as participants adjust to the exercises. Standard care side effects depend on the specific treatments used but could include similar discomfort from physical activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My back pain is moderate to severe according to the Oswestry scale.

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I am seeking treatment for lower back pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had spinal surgery or vertebral fractures.

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I have signs of nerve damage or compression.

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I have significant spine issues not related to a common back problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 10-week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 10-week

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10-week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in gluteal muscle size (cross-sectional area) in cm^2

Change in multifidus muscle size (cross-sectional area) in cm^2

Percent change in gluteal muscle fatty infiltration

+1 more

Secondary study objectives

Point score change in Insomnia Severity Index (ISI)

Point score change in Oswestry Low Back Pain Disability Index (ODI) score

Point score change in Tampa Scale of Kinesiophobia (TSK)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard CareExperimental Treatment1 Intervention

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

Group II: Aquatic TherapyExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met