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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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Quebec Pain Research NetworkOTHER
5 Previous Clinical Trials
10,562 Total Patients Enrolled
Laval UniversityLead Sponsor
420 Previous Clinical Trials
172,627 Total Patients Enrolled
Hugo Massé-AlariePrincipal InvestigatorLaval University, Quebec City
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