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Effect of Thermal Therapy and Exercises on Acute Low Back Pain

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ClinicalTrials.gov Identifier: NCT03986047
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hugo Massé-Alarie, Laval University

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Device: Thermal care Other: Exercises Device: Sham Behavioral: Education for the management of acute low back pain Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Outcomes assessor is blinded to participant's intervention allocation. Participants are blinded to interventions received by other participants.
Primary Purpose: Treatment
Official Title: Effect of Thermal Therapy in Combination With Exercises to Relieve Acute Low Back Pain
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thermal care
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
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 Name: ThermaCare® Back Pain Therapy HeatWraps, by Pfizer

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.

Experimental: Thermal care + exercises
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
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 Name: ThermaCare® Back Pain Therapy HeatWraps, by Pfizer

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.

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.

Sham Comparator: Control
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
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.




Primary Outcome Measures :
  1. Change in functional limitations and symptoms measured with the Oswestry Disability Index (ODI) version 2.1 [ Time Frame: Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up ]
    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.


Secondary Outcome Measures :
  1. Immediate change in current pain intensity after a 1-hour intervention with a numerical rating scale. [ Time Frame: Change from baseline to 1 hour (after a 1-hour intervention) ]
    11-points rating scale (0 to 10), ranging from ''No pain'' to ''Worst pain imaginable''

  2. Change in ''average pain intensity during the last 24 hours'' at 1 week measured with a numerical rating scale. [ Time Frame: Change between baseline and after the 1-week intervention ]
    11-points rating scale (0 to 10), ranging from ''No pain'' to ''Worst pain imaginable''

  3. Change in ''average pain intensity during the last 7 days'' measured with a numerical rating scale. [ Time Frame: Change from baseline at 1-month, 3-month and 6-month follow-ups ]
    11-points rating scale (0 to 10), ranging from ''No pain'' to ''Worst pain imaginable''

  4. Change in pain-related fear measured with Tampa Scale of kinesiophobia (TSK-11). [ Time Frame: Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up ]
    11-item version of the TSK questionnaire that measures problematic beliefs and behaviours associated with pain, focusing on beliefs that pain is damaging and that painful movements should be avoided. Each item is rated on a 4-point Likert scale (1=strongly disagree, 4=strongly agree). The total score ranges from 11 to 44 points, and higher scores signify greater fear of re-injury due to movement.

  5. Change in self-efficacy measured with the Chronic Disease Self-Efficacy Scale - Short-Version (CDSES-6) [ Time Frame: Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up ]
    6-item version of the CDSES-33 questionnaire which measures the self-efficacy to perform behaviors and to achieve outcomes among those with chronic diseases (also validated with chronic pain for French Canadian population). Each item is measured using a numerical scale ranging from 1 (not at all confident) to 10 (totally confident). The total score is obtained by calculating the mean of the 6 items and ranges from 1 to 10. Higher scores indicate higher self-efficacy.

  6. Change in physical activity level at 1 week, assessed by the number of steps walked per day. [ Time Frame: Difference between groups at 1 week ]
    Measured with a fitness wristband

  7. Global Rating of Change [ Time Frame: Collected at 1-week, 1-month, 3-month and 6-month follow-up ]
    A single-item question that asks whether and to what extent the patient perceive change in his global lower back pain condition has occurred, since the initial evaluation, on a 15-point Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • "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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986047


Contacts
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Contact: Hugo Massé-Alarie 418-529-9141 ext 6930 hugo.masse-alarie@fmed.ulaval.ca
Contact: Jean Tittley 418-529-9141 ext 2478 jean.tittley.1@ulaval.ca

Locations
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Canada
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS) Recruiting
Québec, Canada, G1M 2S8
Contact: Hugo Massé-Alarie    418-529-9141 ext 6930    hugo.masse-alarie@fmed.ulaval.ca   
Contact: Jean Tittley    418-529-9141 ext 2478    jean.tittley.1@ulaval.ca   
Sponsors and Collaborators
Laval University

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Responsible Party: Hugo Massé-Alarie, Adjunct professor, Rehabilitation Department, Faculty of Medicine, Laval University
ClinicalTrials.gov Identifier: NCT03986047     History of Changes
Other Study ID Numbers: Heat and exercises for ALBP
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hugo Massé-Alarie, Laval University:
Thermal therapy
Exercises
Pain
Disability
Acute pain

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms