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Thermal care for Lower Back Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS), Québec, CanadaLower Back PainThermal care - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Lower Back Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Collected at 1-week, 1-month, 3-month and 6-month follow-up

Change between baseline and after the 1-week intervention
Change in ''average pain intensity during the last 24 hours'' at 1 week measured with a numerical rating scale.
Change from baseline at 1-month, 3-month and 6-month follow-ups
Change in ''average pain intensity during the last 7 days'' measured with a numerical rating scale.
Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up
Change in functional limitations and symptoms measured with the Oswestry Disability Index (ODI) version 2.1
Change in pain-related fear measured with Tampa Scale of kinesiophobia (TSK-11).
Change in self-efficacy measured with the Chronic Disease Self-Efficacy Scale - Short-Version (CDSES-6)
Hour 1
Immediate change in current pain intensity after a 1-hour intervention with a numerical rating scale.
Collected at 1-week, 1-month, 3-month and 6-month follow-up
Global Rating of Change
Week 1
Change in physical activity level at 1 week, assessed by the number of steps walked per day.

Trial Safety

Safety Progress

1 of 3

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2
LY3857210
2
ABCp
2
Opioids

Trial Design

3 Treatment Groups

Thermal care
1 of 3
Thermal care + exercises
1 of 3
Control
1 of 3

Experimental Treatment

Non-Treatment Group

69 Total Participants · 3 Treatment Groups

Primary Treatment: Thermal care · Has Placebo Group · N/A

Thermal careExperimental Group · 2 Interventions: Thermal care, Education for the management of acute low back pain · Intervention Types: Device, Behavioral
Thermal care + exercisesExperimental Group · 3 Interventions: Thermal care, Exercises, Education for the management of acute low back pain · Intervention Types: Device, Other, Behavioral
ControlShamComparator Group · 2 Interventions: Sham, Education for the management of acute low back pain · Intervention Types: Device, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: collected at 1-week, 1-month, 3-month and 6-month follow-up

Who is running the clinical trial?

Quebec Pain Research NetworkOTHER
3 Previous Clinical Trials
10,383 Total Patients Enrolled
Laval UniversityLead Sponsor
393 Previous Clinical Trials
165,554 Total Patients Enrolled
Hugo Massé-AlariePrincipal InvestigatorLaval University, Quebec City

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You did not have any back pain for three months before the current episode.
You have lower back pain, with or without leg pain, that has limited your activities or changed your daily routine for more than a day, and you have been experiencing it for less than 6 weeks.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Does this research endeavor include elderly individuals in its recruitment efforts?

"The minimum age requirement to be accepted into this research is 18 years old, while the upper limit of eligibility is 65." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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