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Sensory Stimulation Belt for Chronic Low Back Pain in Office Workers

NCT07801755 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-09-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Active Sensory Stimulation Belt

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.

DEVICE

Sham Sensory Stimulation Belt

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Peemongkon Wattananon, PhD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-01-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801755 on ClinicalTrials.gov