Effect of Thermal Therapy and Exercises on Acute Low Back Pain

NCT03986047 | Completed

• 1 other identifier: Heat and exercises for ALBP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Thermal therapy; Exercises; Pain; Disability; Acute pain

Outcome Measures

Primary Outcomes (1)

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

  A list of ten items to assess symptoms (low back pain) and the functional disability it has caused in 9 different areas of everyday life. Score ranges from 0 to 100.

  Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up

Secondary Outcomes (7)

• Immediate change in current pain intensity after a 1-hour intervention with a numerical rating scale.

  Change from baseline to 1 hour (after a 1-hour intervention)

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

  Change between baseline and after the 1-week intervention

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

  Change from baseline at 1-month, 3-month and 6-month follow-ups

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

  Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up

• Change in self-efficacy measured with the Chronic Disease Self-Efficacy Scale - Short-Version (CDSES-6)

  Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up

Study Arms (3)

Thermal care

EXPERIMENTAL

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.

Device: Thermal care; Behavioral: Education for the management of acute low back pain

Thermal care + exercises

EXPERIMENTAL

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).

Device: Thermal care; Other: Exercises; Behavioral: Education for the management of acute low back pain

Control

SHAM COMPARATOR

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.

Device: Sham; Behavioral: Education for the management of acute low back pain

Interventions

Thermal care DEVICE

Wearing of a light elastic lower back heating wrap, which heats up to 40°C within 30 minutes and maintains this temperature continuously for 8 hours. Heat wrap will be worn during the day for 8 hours on 7 consecutive days.

Also known as: ThermaCare® Back Pain Therapy HeatWraps, by Pfizer

Thermal care; Thermal care + exercises

Exercises OTHER

In addition of exercises performed with the physiotherapist at the first session, exercises will be performed at home five times over the next 7 days, for approximately 30 minutes each performing day. Three different categories of exercises will be given: 1) Functional activities exposure (sitting, sit-to-stand, lifting, bending, etc.); 2) cognitive contraction of trunk muscles and basic trunk motor control exercises; 3) mobility of the lumbar spine and preferential direction of movement. Exercises will be chosen and adapted for each participant by a physiotherapist, in function of pain presentation and intensity, and response to exercises.

Thermal care + exercises

Sham DEVICE

The same lower back wrap as the Thermal care group will be used, but cooled down to room temperature (opened in advance). The wrap will be worn following the same parameters (duration, frequency) than the Thermal care group.

Control

Education for the management of acute low back pain BEHAVIORAL

Participants will receive education on the management of acute low back pain by a physiotherapist . The main topics addressed will be patient reassurance, staying active, avoiding bed rest, activity modification, and sitting and bed postures/transfer. Participants will received a document that details advices covered during the session and the physiotherapist will answer any questions.

Control; Thermal care; Thermal care + exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to be suffering from low back pain (LBP) for a period of less than 6 weeks (with or without leg pain) that had limited one's activities or changed the daily routine for more than a day,
• to have been pain free for at least 3 months before the onset of the current LBP episode.

You may not qualify if:

• "red flag" signs that may suggest serious spinal pathology,
• history of spinal surgery,
• obvious lower limb radiculopathy
• fibromyalgia
• rheumatoid arthritis
• important skin lesion in the lumbar area
• alteration of cutaneous sensations or temperature perception
• being pregnant of trying to become

Sponsors & Collaborators

• Quebec Pain Research Network: collaborator
• Laval University: lead

Study Sites (1)

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)

Québec, Quebec, G1M 2S8, Canada

Location

Related Publications (1)

• Cote-Picard C, Tittley J, Mailloux C, Perreault K, Mercier C, Dionne CE, Roy JS, Masse-Alarie H. Effect of thermal therapy and exercises on acute low back pain: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2020 Dec 5;21(1):814. doi: 10.1186/s12891-020-03829-7.

  PMID: 33278897 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Pain; Acute Pain

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Hugo Massé-Alarie

  Laval University, Quebec City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is blinded to participant's intervention allocation. Participants are blinded to the nature of interventions given in the other arms' groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor, Rehabilitation Department, Faculty of Medicine

Model Details: Randomized control trial, as following : * Baseline evaluation * Randomized assignment to one of 3 intervention groups (Thermal + Exercises, Thermal alone, and Control) * Post-intervention assessment (current pain) * 1-week home-based intervention * Reassessment at 1 week, 1 month, 3 months, 6 months

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: April 18, 2019
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)