Health TrialsbyHealthPanel

Sensory Stimulation Belt for Chronic Low Back Pain in Office Workers

ConditionChronic Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorMahidol University

About this trial

This randomized, double-blind, sham-controlled trial will evaluate the effectiveness of a sensory stimulation belt in office workers with chronic nonspecific low back pain. Participants will first complete baseline clinical and sensorimotor assessments and will then be randomly assigned in a 1:1 ratio to receive either an active sensory stimulation belt or a sham belt.

Participants will wear the assigned belt during their usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Daily belt use, pain intensity, adherence, skin reactions, and device-related problems will be recorded in a study logbook, with weekly follow-up by the research team.

Clinical outcomes will include pain intensity, frequency and intensity of low back pain or discomfort episodes, low back pain-related disability, work-related musculoskeletal discomfort, tactile acuity, and pressure pain threshold. Mechanistic outcomes will include corticospinal excitability, somatosensory cortical responses during unstable sitting, postural control, lumbar multifidus motor-unit behavior, and lumbar multifidus contractile response.

The primary objective is to determine whether 4 weeks of active lumbar sensory stimulation produces greater improvements in clinical outcomes than a sham intervention and whether clinical changes are accompanied by changes in sensorimotor and neuromuscular outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Office workers who currently sit for at least 6 hours per workday.

Age between 20 and 60 years.

Chronic nonspecific low back pain for at least 3 months.

Current pain intensity of at least 2/10 on the Numeric Pain Rating Scale.

Disqualifiers

History of seizure in the participant or a family member.

Implanted pacemaker.

Contraindications to TMS or fNIRS, including relevant open wound, infection, skin lesion, or other condition preventing safe measurement.

Acute cerebral hemorrhage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Sensory Stimulation Belt

    Device

    The active sensory stimulation belt is a wearable device designed to deliver controlled mechanical sensory stimulation to the lumbar region during prolonged office work. The belt will be programmed using the optimized vibration parameters identified during the preceding Phase II neurophysiological optimization study. Participants will wear the active belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks.

  • Sham Sensory Stimulation Belt

    Device

    The sham sensory stimulation belt is designed to resemble the active belt in appearance, weight, sound, and user interface. The sham device will provide a brief, low-level surface vibration at the beginning of use and will subsequently cease active stimulation. It will therefore not provide the sustained lumbar sensory stimulation delivered by the active device. Participants will wear the sham belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Active Sensory Stimulation BeltActive comparator 1 intervention
Group B: Sham Sensory Stimulation BeltSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in low back pain intensity

Pain intensity will be measured using the 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Current pain and average pain during the previous 7 days will be recorded. Change in pain intensity from baseline to the end of the 4-week intervention will be compared between the active and sham groups.

Time frame
Baseline and 4 weeks
2

Frequency of low back pain or discomfort episodes

Participants will record the occurrence of low back pain or discomfort episodes in a daily study logbook throughout the 4-week intervention. The number of episodes will be summarized over the intervention period and compared between the active and sham groups.

Time frame
Daily during the 4-week intervention
3

Daily change in low back pain intensity associated with belt use

Participants will rate low back pain intensity using the 0-10 Numeric Pain Rating Scale immediately before the first belt-wear period and after the final belt-wear period of each study day. Repeated daily pain responses will be compared between the active and sham groups.

Time frame
Before and after belt use on each study day for 4 weeks
4

Change in low back pain-related disability

Low back pain-related disability will be assessed using the Oswestry Disability Index (ODI). The questionnaire score is expressed as a percentage, with higher scores indicating greater disability. Change from baseline to 4 weeks will be compared between groups.

Time frame
Baseline and 4 weeks

Secondary outcomes

1

Change in lumbar multifidus and erector spinae motor-evoked potential amplitude

Corticospinal excitability of the lumbar multifidus will be assessed using single-pulse transcranial magnetic stimulation with surface electromyographic recording. Motor-evoked potential amplitude will be quantified as peak-to-peak amplitude in millivolts.

Time frame
Baseline and 4 weeks
2

Change in active motor threshold of lumbar multifidus and erector spinae measured by transcranial magnetic stimulation

Active motor threshold of lumbar multifidus and erector spinae will be determined during standardized submaximal contraction and expressed as a percentage of maximum stimulator output.

Time frame
Baseline and 4 weeks
3

Change in motor-evoked potential latency of lumbar multifidus and erector spinae

Motor-evoked potential latency of lumbar multifidus and erector spinae will be measured as the time in milliseconds from the transcranial magnetic stimulation pulse to the onset of the electromyographic motor-evoked potential.

Time frame
Baseline and 4 weeks
4

Change in cortical motor map volume of lumbar multifidus and erector spinae

Cortical motor map volume of lumbar multifidus and erector spinae will be derived from motor-evoked potential amplitudes recorded across the standardized transcranial magnetic stimulation scalp grid.

Time frame
Baseline and 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Source ClinicalTrials.gov

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