Effectiveness of Motorised Lumbar Support for Non-specific Low Back Pain
ConditionNon-specific Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaval University
About this trial
Low back pain (LBP) represents a common musculoskeletal conditions worlwide, causing substantial disability and economic burden. While traditional semi-rigid lumbar supports are commonly prescribed to alleviate LBP symptoms, their effectiveness remains limited by their static mechanical properties and lack of adaptability to movement patterns. Motorized lumbar support offer a novel approach by allowing the application of controlled decompressive forces while maintaining functional mobility. This experimental study aims to compare the effectiveness between a motorized lumbar support and a standard semi-rigid support in adults with non-specific LBP. Seventy adults with non-specific low back pain (LBP) will be recruited. Primary outcomes (pain intensity and physical functioning \[daily average\]) will be collected daily, while secondary outcomes (average pain intensity over the last week, pain-related disability, etc.) will be assessed at baseline, 3 and 9 weeks after randomization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults between 18 and 65 years old with non-specific low back pain.
Average pain level of ≥3 out of 10 during the previous week.
Pain-related disability ≥10% at ODI.
Pain relief must be present during manual traction, measured by a moderate improvement (+3) on a global rating of change scale (anchors: -7 to +7).
Disqualifiers
Specific cause of low back pain (e.g., fracture, cancer, spinal stenosis, severe spondylolisthesis)
Presence of neuropathic pain (leg or back of 4 at the DN4).
Pregnancy.
Body mass index > 32.
Trial design
Design model
Parallel
Treatments tested in this trial
Motorized lumbar support
Other interventionParticipants will be advised to wear motorized lumbar support for a minimum of 4 hours and a maximum of 8 consecutive hours per day throughout the three-week study period. To reach the target of 4 hours, participants will gradually increase their daily wear time : 2 hours on the first day, 3 hours on the second day and 4 hours on the third day.
Standard lumbar support
Other interventionParticipants will be advised to wear motorized lumbar support for a minimum of 4 hours and a maximum of 8 consecutive hours per day throughout the three-week study period. To reach the target of 4 hours, participants will gradually increase their daily wear time : 2 hours on the first day, 3 hours on the second day and 4 hours on the third day.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Motorized lumbar supportExperimental treatment 1 intervention
Group B: Standard lumbar supportActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity
The numeric scale from 0 to 10 (0: no pain; 10: worst imaginable pain) will be used to rate average pain intensity experienced during the day.
Time frame
Once a day for three weeks.2
Physical functioning
The numeric scale from 0 to 10 (0: no difficulty functioning; 10: inability to function) will be used to rate the ability to carry out daily activities.
Time frame
Once a day for three weeks.Secondary outcomes
1
Pain-related disability
The Oswestry Disability Index (ODI) is a validated and reliable 10-item questionnaire (0 = no disability; 100 = extremely severe disability) recommended for evaluating physical functioning in individuals with LBP.
Time frame
Baseline, week 3 and 9.2
Pain intensity
The 11-point Numeric Rating Scale (0 = "no pain" to 10 = "the worst pain you can imagine") will be used to measure the average pain intensity over the past week.
Time frame
Baseline, week 3 and 9.3
Pain catastrophizing
Pain catastrophizing will be evaluated using the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-administrated questionnaire of 13 questions measuring catastrophizing thoughts contributing to pain on a 5-point likert scale ranging from 0 ("not at all", low level of catastrophizing thoughts) to 5 ("all the time", high level of catastrophizing thoughts).
Time frame
Baseline, week 3 and 9.4
Fear of movement
The Tampa Scale of Kinesiophobia is a self-administrated questionnaire used to assess fear of movement using 17 questions on a 4-point scale ranging from 1 ("strongly disagree", low level of kinesiophobia) to 4 ("strongly agree", high level of kinesiophobia).
Time frame
Baseline, week 3 and 9.Other outcomes
1
Perceived effect of the lumbar support
A "global rating of changes" question type ( "today, what was the effect of wearing the lumbar support") on a 15-point scale (-7 to +7, with -7 = "very great deal worse"; 0 = "no effect" ; +7 = "very great deal better") will be used. The perceived effect of the lumbar support will be used only in the per protocol sensitivity analysis.
Time frame
Once a day for three weeks.Sponsors and contacts
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Source ClinicalTrials.gov