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Heat + Exercise for Acute Low Back Pain

N/A

Waitlist Available

Led By Hugo Massé-Alarie

Research Sponsored by Laval University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at 1-week, 1-month, 3-month and 6-month follow-up

Awards & highlights

Study Summary

This trial will test if the combination of heat and exercises provide additional benefit on short, middle and long-term follow-up in people with acute low back pain.

Who is the study for?

This trial is for individuals who have had lower back pain for less than 6 weeks, which has disrupted their daily activities. They must have been pain-free for at least 3 months prior to the current episode. People with serious spinal issues, history of spinal surgery, severe leg nerve pain, fibromyalgia, rheumatoid arthritis, pregnancy or significant skin lesions in the lumbar area cannot participate.Check my eligibility

What is being tested?

The study tests if combining thermal therapy (superficial heat) with exercises provides more relief from acute low back pain compared to just thermal therapy or no treatment. Participants will be randomly assigned to one of three groups and followed up over six months to measure changes in pain and physical activity.See study design

What are the potential side effects?

Potential side effects may include discomfort from heat application or exercise-related strain. Since this is nonpharmacologic treatment, drug-related side effects are not expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 1-week, 1-month, 3-month and 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 1-week, 1-month, 3-month and 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 1-week, 1-month, 3-month and 6-month follow-up 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 functional limitations and symptoms measured with the Oswestry Disability Index (ODI) version 2.1

Secondary outcome measures

Change in ''average pain intensity during the last 24 hours'' at 1 week measured with a numerical rating scale.

Change in ''average pain intensity during the last 7 days'' measured with a numerical rating scale.

Change in pain-related fear measured with Tampa Scale of kinesiophobia (TSK-11).

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Thermal care + exercisesExperimental Treatment3 Interventions

In addition to heat wrap and pain management education as for Thermal care group, participants of this group will be asked to perform exercises at home over 7 days, targeted on functional capacity, lumbar mobility, and slight contraction of trunk muscle (posture and/or cognitive).

Group II: Thermal careExperimental Treatment2 Interventions

Participants will be asked to wear a heat wrap over the lower lumbar spine, during the day for 8 hours on 7 consecutive days. The Thermal care group will also receive education by a physiotherapist on acute low back pain management.

Group III: ControlPlacebo Group2 Interventions

Participants in the control group will receive the same education program as those of the two other groups. A sham non-heating wrap will be used to control for potential supportive and sensory influence of the heat wrap.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Quebec Pain Research NetworkOTHER

5 Previous Clinical Trials

10,562 Total Patients Enrolled

Laval UniversityLead Sponsor

417 Previous Clinical Trials

172,203 Total Patients Enrolled

Hugo Massé-AlariePrincipal InvestigatorLaval University, Quebec City

Frequently Asked Questions

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

What is the aggregate number of participants in this clinical experiment?

"That is correct. As per the information collected on clinicaltrials.gov, this medical investigation was posted on April 18th 2019 and continues to seek participants as of August 26th 2022. 69 individuals are required at a single facility for trial participation."

Answered by AI

Are there any current opportunities to take part in this clinical trial?

"According to data on clinicaltrials.gov, this investigation is actively recruiting individuals for participation; the trial was first listed in April of 2019 and has seen its most recent update as of August 26th 2022."

Answered by AI

Can I partake in this experiment as a participant?

"Eligibility requirements include being between 18 and 65 years of age with a diagnosis of back pain. Currently, 69 participants are required for this medical trial."

Answered by AI