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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10-week

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Concordia University, MontrealLead Sponsor

22 Previous Clinical Trials

4,637 Total Patients Enrolled

Maryse Fortin, PhDPrincipal InvestigatorConcordia University, Montreal

Media Library

Aquatic Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05823857 — N/A

Muscle Wasting Research Study Groups: Aquatic Therapy, Standard Care

Muscle Wasting Clinical Trial 2023: Aquatic Therapy Highlights & Side Effects. Trial Name: NCT05823857 — N/A

Aquatic Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05823857 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can prospective participants still join this clinical research?

"Affirmative, according to clinicaltrials.gov's records, this medical experiment is currently enlisting test subjects. It was first posted on November 1st 2022 and has since been modified on April 10th 2023. This study requires 30 individuals from one site for participation."

Answered by AI

Does this study only include participants aged 25 or older?

"This clinical trial requires participants to be within the age bracket of 18-65. Patients below 18 years old can enroll in 64 studies, while those 65 and over have access to 313 different opportunities."

Answered by AI

What are the prime goals being pursued in this clinical investigation?

"This trial's primary outcome, which will be examined over a 10 week baseline period, is the alteration in gluteal muscle size (cross-sectional area). The secondary metrics for observation include changes in SF-12 Health Survey scores (which range from 0 to 100), Tampa Scale of Kinesiophobia ratings (ranging between 17 and 68) and Pain Catastrophizing Scale points."

Answered by AI

Might I be allowed to join this medical experiment?

"This trial is in search of 30 volunteers, aged 18-65 with muscle wasting. The criteria for these participants include a diagnosis of chronic non-specific lower back pain (LBP) lasting 3+ months, currently receiving care for the condition, fluency in English or French and lack of involvement in sports/fitness specifically targeting the lumbar muscles over the preceding three months."

Answered by AI

How many individuals are being considered for the research endeavor?

"Affirmative, the information on clinicaltrials.gov indicates that this medical trial is seeking participants. Initially posted in November of 2022 and last updated April 10th 2023, 30 people must be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Maryse Fortin 2022. "Effect of an Aquatic Exercise Program in Patients With Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05823857.

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