NCT03986047

Effect of Thermal Therapy and Exercises on Acute Low Back Pain

Completed NA Last updated 20 January 2026

What this trial tests

NA trial testing Thermal care in Low Back Pain in 100 participants. Completed in 15 April 2024.

Timeline

18 April 2019

Primary endpoint
15 April 2024

15 April 2024

Quick facts

Lead sponsor	Laval University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	18 April 2019
Primary completion	15 April 2024
Estimated completion	15 April 2024
Sites	1 location across Canada

Drugs / interventions tested

• Thermal care
• Exercises
• Sham
• Education for the management of acute low back pain

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Laval University

Who can join

Adults 18 to 65, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Low back pain (LBP) ranks among the first diseases in term of years lived with disability. The latest Clinical Guideline from the American College of Physicians for acute LBP recommends to select "nonpharmacologic treatment with superficial heat, massage, acupuncture or spinal manipulation". The application of superficial heat ("thermal therapy") may provide enough pain relief in the acute phase to remain active, which is recommended to prevent the development of chronicity. However, no studies have tested if the combination of heat and exercises provide additional benefit on short, middle and long-term follow-up in people with acute LBP.

Hence, the main objective of this study is to determine the immediate, short-, middle- and long-term effect of continuous low-level thermal therapy in combination or not with exercises on pain, disability, and physical activity level in people with acute LBP.

Project hypothesis : The Thermal care + Exercises group will show greater improvement in pain, disability and physical activity level than both Thermal care and Control groups for immediate, short-, middle- and long-term follow-ups.

Sixty individuals with acute LBP will be recruited. This study will include six assessments over 6 months. At the baseline evaluation, participants will complete questionnaires on symptoms, disability, pain-related fear and self-efficacy. Afterwards, participants will be randomly assigned to one of three intervention programs: 1) Thermal care group, 2) Exercises + Thermal care group, and 3) Control group. They will immediately meet a physical therapist to review and perform their assigned program.

Participants will then take part in their assigned 7-day intervention program, during which they will wear a fitness wristband to track physical activity level. Finally, the same outcomes will be reassessed to determine the effect of intervention at 1 week, 1 month, 3 months and 6 months after baseline.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Role for Superficial Heat Therapy in the Management of Non-Specific, Mild-to-Moderate Low Back Pain in Current Clinical Practice: A Narrative Review.
   Freiwald J, Magni A, Fanlo-Mazas P, Paulino E, et al · · 2021 · cited 27× · PMID 34440524 · DOI 10.3390/life11080780
2. Exercise therapy for treatment of acute non-specific low back pain.
   IJzelenberg W, Oosterhuis T, Hayden JA, Koes BW, et al · · 2023 · cited 15× · PMID 37646368 · DOI 10.1002/14651858.cd009365.pub2
3. Effect of thermal therapy and exercises on acute low back pain: a protocol for a randomized controlled trial.
   Côté-Picard C, Tittley J, Mailloux C, Perreault K, et al · · 2020 · cited 5× · PMID 33278897 · DOI 10.1186/s12891-020-03829-7
4. Effects of heatwrap and exercise in acute low back pain: a multi-arm randomised controlled trial
   Côté-Picard C, Tittley J, Mailloux C, Desgagnés A, et al · · 2025 · DOI 10.1101/2025.09.07.25335260
5. Subgrouping People With Acute Low Back Pain Based on Psychological, Sensory, and Motor Characteristics: A Cross-Sectional Study.
   Ippersiel P, Côté-Picard C, Roy JS, Massé-Alarie H. · · 2025 · PMID 40035340 · DOI 10.1002/ejp.70006