Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03986047 |
| Other study ID # |
Heat and exercises for ALBP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 18, 2019 |
| Est. completion date |
April 15, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Laval University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Low back pain (LBP) ranks among the first diseases in term of years lived with disability,
which is mostly explained by the development of recurrent or chronic pain. A systematic
review observed that 62% of patients still have pain 12 months after onset (recurrent and
chronic) while another estimated that between 2% and 34% of acute cases will develop chronic
LBP. These rates highlight the need to identify the best therapeutic approaches at the acute
stage to prevent transition to chronicity and high recurrence. 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") presented the strongest evidence
(moderate) for short-term reduction in pain. Four randomized controlled trials (RCT) that
tested the effect of a wearable heatwrap (the most studied form of thermal therapy in acute
LBP) reported a reduction in pain and disability up to 2 days after cessation of the
intervention: an effect superior to Ibuprofen, Acetaminophen or oral placebo. Heatwrap may
provide enough pain relief in the acute phase to remain active, which is recommended to
prevent the development of chronicity. One RCT showed that the addition of a heatwrap to
exercise provided greater short-term improvement in pain/disability than exercise alone.
Although some authors suggest that an increase in physical activity level may explain such an
effect, this assumption has not been tested yet.
Hence, the main objective of this RCT 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.
Participants: Individuals with acute LBP will be included according to the mentioned
inclusion/exclusion criteria. They will be recruited from medical and through the electronic
mailing list of Université Laval (> 52,000 individuals). The list of participants of the
Quebec Low Back Pain Study (QLBPS Core Dataset, funded by the QPRN) will also be used - all
participants in the Quebec City area recruited for the QLBPS Core Dataset will be referred
for the present project.
Study Design: This study will include six assessments over 6 months : baseline pre, 1-hour
post, 1 week, 1 month, 3 months, 6 months. At the baseline evaluation (baseline pre),
participants will complete self-administered questionnaires on symptoms and disability
(Numerical scale for pain, Oswestry Disability Index - ODI, Global Rating of Change - GRC),
on pain-related fear (Tampa Scale of Kinesiophobia - TSK) and on pain-related self-efficacy
(Chronic Disease Self-Efficacy Scale short version - CDSES-6). Finally, participants will be
randomly assigned to one of three intervention programs: 1) Thermal care group, 2) Thermal
care + Exercises group, and 3) Control group. Immediately after group assignment (same
session), participants will meet a physical therapist (PT) to review their assigned program
(60-minutes meeting), during which a ThermaCare® Heat wrap or a sham wrap will be applied by
the PT. In Thermal Care + Exercises group, an exercise program will be taught by the PT then
performed by participants. General advices on the management of acute LBP will be given to
all participants. Thereafter, the immediate effect of thermal therapy on pain will be
evaluated (1-hour post-intervention assesment).
After the baseline evaluation and PT session, participants will perform their assigned 7-day
intervention program. Every day, they will complete a logbook related to their pain level
during the previous day and to their adherence to their program. In addition, participants
will wear a fitness wristband to track physical activity level for 7 days (number of steps
per day). Then, pain, ODI, GRC, TSK and CDSES-6 will be assessed at 1 week, 1 month, 3 months
and 6 months after baseline to determine short-, middle-, and long-term effect of
interventions.
Randomisation: a list will be generated using a computer random number generator by an
independent research assistant (allocation concealed in sealed and opaque envelopes).
Sample size & Statistical analyses: Based on sample size calculation, calculated for the
primary outcome (ODI) and previous data from the project investigators group (n=50 with acute
LBP), 20 participants are required per group (G*Power 3.1.7; effect size: 0.80, α = 0.05, β =
0.80, mean baseline ODI of 44.0 +/- 13.5, lost at follow-up = 10%). Thus, 60 participants
with acute LBP will be recruited.
To determine the effect of interventions, two-way ANOVA (Group x Time) will be performed
(after confirming normality and homogeneity of variance). Bonferroni adjustments for multiple
comparisons will be used (posthoc), and effect sizes will be reported (η2).
