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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

Must not have

Important skin lesion in the lumbar area

History of spinal surgery

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

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

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I have a significant skin issue on my lower back.

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I have had surgery on my spine.

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I have severe leg pain due to a nerve issue.

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I have been diagnosed with fibromyalgia.

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I have rheumatoid arthritis.

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

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

Primary study objectives

Change in functional limitations and symptoms measured with the Oswestry Disability Index (ODI) version 2.1

Secondary study objectives

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thermal care

2019

N/A

~100

Education for the management of acute low back pain

2019

N/A

~100