Sensory Stimulation Belt for Chronic Low Back Pain in Office Workers
Not yet recruitingNot applicableNCT07801755
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effectiveness of a Sensory Stimulation Belt for Office Workers With Chronic Nonspecific Low Back Pain: A Double-Blind, Sham-Controlled Randomized Trial
- Conditions
- Interventions
- Device: Active Sensory Stimulation Belt
- Device: Sham Sensory Stimulation Belt
- Sponsor
- Mahidol University
- Start date
- 2028-01-01
- Primary completion
- 2028-12-31
- Sex
- All
- Age range
- from 20 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Thailand
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Office workers who currently sit for at least 6 hours per workday. 2. Age between 20 and 60 years. 3. Chronic nonspecific low back pain for at least 3 months. 4. Current pain intensity of at least 2/10 on the Numeric Pain Rating Scale. Exclusion Criteria: 1. History of seizure in the participant or a family member. 2. Implanted pacemaker. 3. Contraindications to TMS or fNIRS, including relevant open wound, infection, skin lesion, or other condition preventing safe measurement. 4. Acute cerebral hemorrhage. 5. History of major spinal surgery, fracture, or traumatic injury to the lumbar spine. 6. Evidence of neurological deficits, including radiculopathy, loss of sensation, or motor weakness in the lower limbs. 7. Diagnosis of a systemic inflammatory condition, including ankylosing spondylitis or rheumatoid arthritis. 8. Allergy to adhesives or history of severe skin sensitivity to vibration or mechanical pressure. 9. Body mass index greater than 30 kg/m2 because of potential effects on RUSI, dEMG, and fNIRS signal quality. 10. Pregnancy.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07801755