Effect of Thermal Therapy and Exercises on Acute Low Back Pain

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

Interventions

DEVICE

Thermal care

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.

OTHER

Exercises

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.

DEVICE

Sham

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.

BEHAVIORAL

Education for the management of acute low back pain

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.

Sponsors & Collaborators

• Quebec Pain Research Network

  collaborator OTHER

• Laval University

  lead OTHER

Principal Investigators

• Hugo Massé-Alarie · Laval University, Quebec City

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-18

Primary Completion

2024-04-15

Completion

2024-04-15

Countries

• Canada

Study Locations