Chronic Low Back PainLSS-BELTNCT07801755
Sensory Stimulation Belt for Chronic Low Back Pain in Office Workers
A study testing Active Sensory Stimulation Belt in people with Chronic Low Back Pain, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Active Sensory Stimulation Belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2028to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- History of major spinal surgery, fracture, or traumatic injury to the lumbar spine.
- Evidence of neurological deficits, including radiculopathy, loss of sensation, or motor weakness in the lower limbs.
Show all 10Show fewer
- Diagnosis of a systemic inflammatory condition, including ankylosing spondylitis or rheumatoid arthritis.
- Allergy to adhesives or history of severe skin sensitivity to vibration or mechanical pressure.
- Body mass index greater than 30 kg/m2 because of potential effects on RUSI, dEMG, and fNIRS signal quality.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
Peemongkon Wattananon, PhD, +66-2-441-5450 ext. 21803, peemongkon.wat@mahidol.ac.th
Apinkarn Jaroenlarp, PhD Candidate, +66-89-329-6194, j.apinkarn@hotmail.com
About this study
Official title: Effectiveness of a Sensory Stimulation Belt for Office Workers With Chronic Nonspecific Low Back Pain: A Double-Blind, Sham-Controlled Randomized 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.
Read more
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.
Read the detailed description
Phase III is a prospective, double-blind, sham-controlled randomized clinical trial designed to evaluate the clinical effectiveness and potential sensorimotor mechanisms of a wearable sensory stimulation belt in office workers with chronic nonspecific low back pain.
After eligibility screening and written informed consent, participants will undergo a baseline laboratory assessment. Baseline clinical assessments will include pain intensity, low back pain-related disability, work-related musculoskeletal discomfort, movement-control testing, tactile acuity, and pressure pain threshold.
Baseline mechanistic assessments will characterize corticospinal, cortical, postural, motor-unit, and lumbar multifidus function. Corticospinal excitability will be assessed using single-pulse transcranial magnetic stimulation (TMS), with motor-evoked potentials recorded from the lumbar multifidus and erector spinae muscles. Somatosensory cortical and postural responses will be assessed during unstable sitting using functional near-infrared spectroscopy (fNIRS) over the bilateral primary somatosensory cortex together with inertial measurement units (IMUs). Participants will also perform a repeated loaded forward-bending task while lumbar multifidus motor-unit behavior is recorded using decomposition electromyography (dEMG) and trunk movement is recorded using IMUs. Lumbar multifidus morphology and contractile response will be assessed using rehabilitative ultrasound imaging (RUSI) at rest and during contralateral arm lifting.
Following completion of the baseline assessment, participants will be randomly allocated in a 1:1 ratio to an active sensory stimulation belt group or a sham belt group using a computer-generated block randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by a research assistant who is not involved in outcome assessment.
Participants assigned to the active intervention group will receive a sensory stimulation belt programmed with the lumbar vibration parameters identified during the preceding Phase II parameter-optimization study. Participants assigned to the sham group will receive a belt designed to have similar appearance, weight, sound, and user interface. The sham belt will provide only a brief, low-level surface vibration at the beginning of use and will subsequently cease active stimulation so that it does not provide the intended sustained sensory stimulation.
Participants and outcome assessors will be blinded to group allocation. Device programming and allocation management will be performed by research personnel who are not involved in clinical or mechanistic outcome assessment.
Participants will be instructed to wear their assigned belt during their usual office working hours for at least 4 hours per day, 5 days per week, for 4 consecutive weeks. Participants may continue their usual occupational activities while wearing the belt.
Throughout the 4-week intervention period, participants will complete a daily study logbook documenting belt-wear duration, number of wear sessions, pain intensity before and after belt use, local discomfort or skin reactions, technical or device-related problems, and reasons for missed use when applicable. A member of the research team will conduct weekly follow-up to review adherence, identify technical problems, reinforce study procedures, and document adverse events.
At the end of the 4-week intervention, participants will return to the laboratory for post-intervention assessments using procedures comparable to the baseline assessment. Clinical assessments will include pain intensity, low back pain-related disability, work-related musculoskeletal discomfort, movement-control testing, tactile acuity, and pressure pain threshold. Mechanistic assessments will include corticospinal excitability using TMS, somatosensory cortical and postural responses during unstable sitting using fNIRS and IMUs, lumbar multifidus motor-unit behavior during loaded forward bending using dEMG, and lumbar multifidus contractile response using RUSI.
The primary efficacy analysis will compare changes in clinical outcomes between the active and sham groups over the 4-week intervention period. Linear mixed-effects models will be used to evaluate group, time, and group-by-time interaction effects for continuous outcomes. Repeated daily pain or discomfort measurements will also be evaluated using mixed-effects models. The frequency of pain or discomfort episodes may be analyzed using Poisson or negative-binomial regression, depending on the distribution of the data.
The primary analysis will follow the intention-to-treat principle. A complementary per-protocol analysis will be performed for participants who complete at least 75% of the prescribed belt use. Treatment effects will be reported with 95% confidence intervals.
Safety, adherence, comfort, usability, and device-related problems will be monitored throughout the intervention. Belt use will be discontinued if a participant requests discontinuation, develops clinically important symptom aggravation, experiences a significant adverse event, or develops a device-related problem that makes continued use inappropriate.
- Conditions
- Chronic Low Back Pain
- Being tested
- Active Sensory Stimulation Belt, Sham Sensory Stimulation Belt
- Keywords
- Chronic nonspecific low back pain, Office workers, Sensory stimulation, Lumbar vibration, Wearable device, Lumbar multifidus, Sensorimotor control, Somatosensory cortex, Proprioception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Sensory Stimulation BeltDevice
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 BeltDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Sensory Stimulation Belt | Active comparator | Participants will receive an active sensory stimulation belt programmed using the optimized lumbar vibration parameters identified during Phase II. Participants will wear the belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Receives: Device: Active Sensory Stimulation Belt |
| Sham Sensory Stimulation Belt | Sham comparator | Participants will receive a sham belt 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. Participants will wear the sham belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Receives: Device: Sham Sensory Stimulation Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
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.
Measured: Daily during the 4-week intervention
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.
Measured: Before and after belt use on each study day for 4 weeks
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.
Measured: Baseline and 4 weeks
Change in work-related musculoskeletal discomfort
Work-related musculoskeletal discomfort will be assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), which evaluates the frequency, severity, and interference with work associated with musculoskeletal discomfort during the previous working week. The lower-back score and total CMDQ score will be analyzed.
Measured: Baseline and 4 weeks
Change in lumbar tactile acuity
Lumbar tactile acuity will be assessed using a three-point aesthesiometer to determine two-point discrimination threshold over the lumbar region. Lower discrimination thresholds indicate greater tactile spatial acuity.
Measured: Baseline and 4 weeks
Change in pressure pain threshold
Pressure pain threshold will be measured using a digital pressure algometer at predefined local lumbar and remote anatomical sites. Pressure will be gradually increased until the participant first reports pain. Change in pressure pain threshold from baseline to 4 weeks will be compared between groups.
Measured: Baseline and 4 weeks
Secondary outcomes (16)
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
Change in cortical motor map area of lumbar multifidus and erector spinae
Cortical motor map area of lumbar multifidus and erector spinae will be calculated from the number and spatial distribution of responsive stimulation sites within the standardized transcranial magnetic stimulation grid.
Measured: Baseline and 4 weeks
Change in oxygenated hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting
Oxygenated hemoglobin concentration will be recorded from the bilateral primary somatosensory cortex using functional near-infrared spectroscopy during unstable sitting. The primary fNIRS metric will be the baseline-corrected change in oxygenated hemoglobin concentration during the unstable sitting condition.
Measured: Baseline and 4 weeks
Change in deoxygenated hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting
Deoxygenated hemoglobin concentration will be recorded from the bilateral primary somatosensory cortex using functional near-infrared spectroscopy during unstable sitting.
Measured: Baseline and 4 weeks
Change in total hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting
Total hemoglobin concentration will be calculated from oxygenated and deoxygenated hemoglobin signals recorded using functional near-infrared spectroscopy during unstable sitting.
Measured: Baseline and 4 weeks
Change in lumbar resultant angular velocity during unstable sitting
Inertial measurement units positioned over the lumbar and pelvic regions will record trunk movement during unstable sitting. Resultant angular velocity will be calculated in degrees per second as a quantitative measure of postural-control behavior.
Measured: Baseline and 4 weeks
Change in number of lumbar multifidus motor units during loaded forward bending
Decomposition electromyography will be used to identify lumbar multifidus motor units during repeated 45-degree trunk flexion-extension while holding 5% of body weight. The number of motor units meeting predefined decomposition quality criteria will be recorded.
Measured: Baseline and 4 weeks
Change in lumbar multifidus motor-unit action-potential amplitude during loaded forward bending
Lumbar multifidus motor-unit action-potential amplitude will be derived from decomposition electromyography during the loaded forward-bending task and expressed in microvolts.
Measured: Baseline and 4 weeks
Change in lumbar multifidus motor-unit firing rate during loaded forward bending
Lumbar multifidus motor-unit firing rate will be quantified using decomposition electromyography during repeated loaded forward bending and expressed in pulses per second.
Measured: Baseline and 4 weeks
Change in lumbar multifidus percentage thickness change during contraction
Lumbar multifidus thickness will be measured using B-mode rehabilitative ultrasound imaging at the L4-L5 level at rest and during contralateral arm lifting against standardized resistance. Percentage thickness change will be calculated as [(contracted thickness - resting thickness) / resting thickness] × 100 and used as an estimate of lumbar multifidus contractile response.
Measured: Baseline and 4 weeks
Change in lumbar multifidus absolute thickness change during contraction
Absolute lumbar multifidus thickness change will be calculated as contracted thickness minus resting thickness using rehabilitative ultrasound imaging at the L4-L5 level.
Measured: Baseline and 4 weeks
Belt-wear adherence
Adherence will be determined from the participant daily logbook using recorded belt-wear duration and frequency. The prescribed use is at least 4 hours per day, 5 days per week, for 4 weeks. Adherence will be summarized as the number and percentage of prescribed study days completed and the proportion of prescribed belt-wear time completed.
Measured: Daily throughout the 4-week intervention
Number of participants with device-related adverse events
Device-related adverse events will include increased low back pain, local discomfort, skin redness or irritation, excessive warmth, numbness, dizziness, or other symptoms judged to be related to use of the study belt. Events will be recorded in the participant daily logbook and reviewed during weekly follow-up contacts. The number of participants experiencing at least one device-related adverse event will be reported for each group.
Measured: Throughout the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jan 2028 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an active sensory stimulation belt group or a sham belt group. Both groups will use the assigned belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Clinical and mechanistic outcomes will be assessed at baseline and after the 4-week intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peemongkon Wattananon, Mahidol University
- Investigators
- Peemongkon Wattananon, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801755
- Sponsor's protocol ID
- Sensory-Stimulation-Phase-III
- Acronym
- LSS-BELT
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications from this trial may be shared with qualified researchers upon reasonable request. Shared data may include de-identified clinical outcomes, adherence data, and processed mechanistic outcome data. Direct identifiers and information that could reasonably permit participant re-identification will not be shared. Data sharing will be subject to approval by the principal investigator and applicable Mahidol University and ethics requirements, and may require a data-use agreement.
Publications
Kent P, Laird R, Haines T. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial. BMC Musculoskelet Disord. 2015 May 29;16:131. doi: 10.1186/s12891-015-0591-5.
PubMed 26022102Park CH, Kang JH. Efficacy and safety assessment of orthopedic device (LSM-01) for low back pain: A randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31068. doi: 10.1097/MD.0000000000031068.
PubMed 36316867del Pozo-Cruz B, Hernandez Mocholi MA, Adsuar JC, Parraca JA, Muro I, Gusi N. Effects of whole body vibration therapy on main outcome measures for chronic non-specific low back pain: a single-blind randomized controlled trial. J Rehabil Med. 2011 Jul;43(8):689-94. doi: 10.2340/16501977-0830.
PubMed 21687923Tariq N, Khan Z, Veqar Z. Effect of Whole-Body Vibration on Balance or Proprioception in Nonspecific Chronic Low Back Pain: A Systematic Review. J Chiropr Med. 2023 Dec;22(4):284-293. doi: 10.1016/j.jcm.2023.04.006. Epub 2023 Jun 14.
PubMed 38205229Zafar T, Zaki S, Alam MF, Sharma S, Babkair RA, Nuhmani S, Pandita S. Effect of Whole-Body Vibration Exercise on Pain, Disability, Balance, Proprioception, Functional Performance and Quality of Life in People with Non-Specific Chronic Low Back Pain: A Systematic Review and Meta-Analysis. J Clin Med. 2024 Mar 13;13(6):1639. doi: 10.3390/jcm13061639.
PubMed 38541865Li Q, Liu P, Wang Z, Li X. Vibration therapy to improve pain and function in patients with chronic low back pain: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Sep 26;18(1):727. doi: 10.1186/s13018-023-04217-2.
PubMed 37752526Sungnak P, Songjaroen S, Krityakiarana W, Wang HK, Richards J, Wattananon P. Individuals With Impaired Lumbopelvic Control Demonstrate Lumbar Multifidus Muscle Activation Deficit Using Ultrasound Imaging in Conjunction With Electrical Stimulation: A Cross-sectional Study. Arch Phys Med Rehabil. 2022 Oct;103(10):1951-1957. doi: 10.1016/j.apmr.2022.02.010. Epub 2022 Mar 9.
PubMed 35278466Wattananon P, Kongoun S, Klahan K, Silfies SP, Gilliam JR, Richards J. Trunk kinematics and motor unit behavior during different loads and speeds in individuals with and without aberrant movement patterns during active forward bending: A cross-sectional study. PLoS One. 2025 Apr 16;20(4):e0321084. doi: 10.1371/journal.pone.0321084. eCollection 2025.
PubMed 40238819Wattananon P, Thu KW, Maharjan S, Sornkaew K, Wang HK. Cortical excitability and multifidus activation responses to transcranial direct current stimulation in patients with chronic low back pain during remission. Sci Rep. 2023 Sep 27;13(1):16242. doi: 10.1038/s41598-023-43597-7.
PubMed 37758911Masse-Alarie H, Shraim M, Hodges PW. Sensorimotor Integration in Chronic Low Back Pain. Neuroscience. 2024 Aug 6;552:29-38. doi: 10.1016/j.neuroscience.2024.06.008. Epub 2024 Jun 13.
PubMed 38878816Gilliam JR, Mandal D, Wattananon P, Banerjee S, Herter TM, Silfies SP. Vibration-Induced Alteration in Trunk Extensor Muscle Proprioception as a Model for Impaired Trunk Control in Low Back Pain. Brain Sci. 2024 Jun 28;14(7):657. doi: 10.3390/brainsci14070657.
PubMed 39061397
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Sensory Stimulation Belt for Office Workers With Chronic Nonspecific Low Back Pain: A Double-Blind, Sham-Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT07801755
- Acronym / sponsor ID
- LSS-BELT / Sensory-Stimulation-Phase-III
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic nonspecific low back pain, Office workers, Sensory stimulation, Lumbar vibration, Wearable device, Lumbar multifidus, Sensorimotor control, Somatosensory cortex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase III is a prospective, double-blind, sham-controlled randomized clinical trial designed to evaluate the clinical effectiveness and potential sensorimotor mechanisms of a wearable sensory stimulation belt in office workers with chronic nonspecific low back pain.
After eligibility screening and written informed consent, participants will undergo a baseline laboratory assessment. Baseline clinical assessments will include pain intensity, low back pain-related disability, work-related musculoskeletal discomfort, movement-control testing, tactile acuity, and pressure pain threshold.
Baseline mechanistic assessments will characterize corticospinal, cortical, postural, motor-unit, and lumbar multifidus function. Corticospinal excitability will be assessed using single-pulse transcranial magnetic stimulation (TMS), with motor-evoked potentials recorded from the lumbar multifidus and erector spinae muscles. Somatosensory cortical and postural responses will be assessed during unstable sitting using functional near-infrared spectroscopy (fNIRS) over the bilateral primary somatosensory cortex together with inertial measurement units (IMUs). Participants will also perform a repeated loaded forward-bending task while lumbar multifidus motor-unit behavior is recorded using decomposition electromyography (dEMG) and trunk movement is recorded using IMUs. Lumbar multifidus morphology and contractile response will be assessed using rehabilitative ultrasound imaging (RUSI) at rest and during contralateral arm lifting.
Following completion of the baseline assessment, participants will be randomly allocated in a 1:1 ratio to an active sensory stimulation belt group or a sham belt group using a computer-generated block randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by a research assistant who is not involved in outcome assessment.
Participants assigned to the active intervention group will receive a sensory stimulation belt programmed with the lumbar vibration parameters identified during the preceding Phase II parameter-optimization study. Participants assigned to the sham group will receive a belt designed to have similar appearance, weight, sound, and user interface. The sham belt will provide only a brief, low-level surface vibration at the beginning of use and will subsequently cease active stimulation so that it does not provide the intended sustained sensory stimulation.
Participants and outcome assessors will be blinded to group allocation. Device programming and allocation management will be performed by research personnel who are not involved in clinical or mechanistic outcome assessment.
Participants will be instructed to wear their assigned belt during their usual office working hours for at least 4 hours per day, 5 days per week, for 4 consecutive weeks. Participants may continue their usual occupational activities while wearing the belt.
Throughout the 4-week intervention period, participants will complete a daily study logbook documenting belt-wear duration, number of wear sessions, pain intensity before and after belt use, local discomfort or skin reactions, technical or device-related problems, and reasons for missed use when applicable. A member of the research team will conduct weekly follow-up to review adherence, identify technical problems, reinforce study procedures, and document adverse events.
At the end of the 4-week intervention, participants will return to the laboratory for post-intervention assessments using procedures comparable to the baseline assessment. Clinical assessments will include pain intensity, low back pain-related disability, work-related musculoskeletal discomfort, movement-control testing, tactile acuity, and pressure pain threshold. Mechanistic assessments will include corticospinal excitability using TMS, somatosensory cortical and postural responses during unstable sitting using fNIRS and IMUs, lumbar multifidus motor-unit behavior during loaded forward bending using dEMG, and lumbar multifidus contractile response using RUSI.
The primary efficacy analysis will compare changes in clinical outcomes between the active and sham groups over the 4-week intervention period. Linear mixed-effects models will be used to evaluate group, time, and group-by-time interaction effects for continuous outcomes. Repeated daily pain or discomfort measurements will also be evaluated using mixed-effects models. The frequency of pain or discomfort episodes may be analyzed using Poisson or negative-binomial regression, depending on the distribution of the data.
The primary analysis will follow the intention-to-treat principle. A complementary per-protocol analysis will be performed for participants who complete at least 75% of the prescribed belt use. Treatment effects will be reported with 95% confidence intervals.
Safety, adherence, comfort, usability, and device-related problems will be monitored throughout the intervention. Belt use will be discontinued if a participant requests discontinuation, develops clinically important symptom aggravation, experiences a significant adverse event, or develops a device-related problem that makes continued use inappropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an active sensory stimulation belt group or a sham belt group. Both groups will use the assigned belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Clinical and mechanistic outcomes will be assessed at baseline and after the 4-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Active Sensory Stimulation Belt | Active comparator | Device: Active Sensory Stimulation BeltParticipants will receive an active sensory stimulation belt programmed using the optimized lumbar vibration parameters identified during Phase II. Participants will wear the belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. |
| Sham Sensory Stimulation Belt | Sham comparator | Device: Sham Sensory Stimulation BeltParticipants will receive a sham belt 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. Participants will wear the sham belt during usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- History of major spinal surgery, fracture, or traumatic injury to the lumbar spine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Sensory Stimulation BeltThe 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 | Active Sensory Stimulation Belt |
| Sham Sensory Stimulation BeltThe 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. | Device | Sham Sensory Stimulation Belt |
Primary outcome
Change in low back pain intensity
Time frame: Baseline and 4 weeks
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.
Frequency of low back pain or discomfort episodes
Time frame: Daily during the 4-week intervention
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.
Daily change in low back pain intensity associated with belt use
Time frame: Before and after belt use on each study day for 4 weeks
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.
Change in low back pain-related disability
Time frame: Baseline and 4 weeks
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.
Change in work-related musculoskeletal discomfort
Time frame: Baseline and 4 weeks
Work-related musculoskeletal discomfort will be assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), which evaluates the frequency, severity, and interference with work associated with musculoskeletal discomfort during the previous working week. The lower-back score and total CMDQ score will be analyzed.
Change in lumbar tactile acuity
Time frame: Baseline and 4 weeks
Lumbar tactile acuity will be assessed using a three-point aesthesiometer to determine two-point discrimination threshold over the lumbar region. Lower discrimination thresholds indicate greater tactile spatial acuity.
Change in pressure pain threshold
Time frame: Baseline and 4 weeks
Pressure pain threshold will be measured using a digital pressure algometer at predefined local lumbar and remote anatomical sites. Pressure will be gradually increased until the participant first reports pain. Change in pressure pain threshold from baseline to 4 weeks will be compared between groups.
16 secondary outcomes
Change in lumbar multifidus and erector spinae motor-evoked potential amplitude
Time frame: Baseline and 4 weeks
Change in active motor threshold of lumbar multifidus and erector spinae measured by transcranial magnetic stimulation
Time frame: Baseline and 4 weeks
Change in motor-evoked potential latency of lumbar multifidus and erector spinae
Time frame: Baseline and 4 weeks
Change in cortical motor map volume of lumbar multifidus and erector spinae
Time frame: Baseline and 4 weeks
Change in cortical motor map area of lumbar multifidus and erector spinae
Time frame: Baseline and 4 weeks
Change in oxygenated hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting
Time frame: Baseline and 4 weeks
Change in deoxygenated hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting
Time frame: Baseline and 4 weeks
Change in total hemoglobin concentration in the bilateral primary somatosensory cortex during unstable sitting
Time frame: Baseline and 4 weeks
Change in lumbar resultant angular velocity during unstable sitting
Time frame: Baseline and 4 weeks
Change in number of lumbar multifidus motor units during loaded forward bending
Time frame: Baseline and 4 weeks
Change in lumbar multifidus motor-unit action-potential amplitude during loaded forward bending
Time frame: Baseline and 4 weeks
Change in lumbar multifidus motor-unit firing rate during loaded forward bending
Time frame: Baseline and 4 weeks
Change in lumbar multifidus percentage thickness change during contraction
Time frame: Baseline and 4 weeks
Change in lumbar multifidus absolute thickness change during contraction
Time frame: Baseline and 4 weeks
Belt-wear adherence
Time frame: Daily throughout the 4-week intervention
Number of participants with device-related adverse events
Time frame: Throughout the 4-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 26022102Kent P, Laird R, Haines T. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial. BMC Musculoskelet Disord. 2015 May 29;16:131. doi: 10.1186/s12891-015-0591-5.
- Background: PubMed 36316867Park CH, Kang JH. Efficacy and safety assessment of orthopedic device (LSM-01) for low back pain: A randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31068. doi: 10.1097/MD.0000000000031068.
- Background: PubMed 21687923del Pozo-Cruz B, Hernandez Mocholi MA, Adsuar JC, Parraca JA, Muro I, Gusi N. Effects of whole body vibration therapy on main outcome measures for chronic non-specific low back pain: a single-blind randomized controlled trial. J Rehabil Med. 2011 Jul;43(8):689-94. doi: 10.2340/16501977-0830.
- Background: PubMed 38205229Tariq N, Khan Z, Veqar Z. Effect of Whole-Body Vibration on Balance or Proprioception in Nonspecific Chronic Low Back Pain: A Systematic Review. J Chiropr Med. 2023 Dec;22(4):284-293. doi: 10.1016/j.jcm.2023.04.006. Epub 2023 Jun 14.
- Background: PubMed 38541865Zafar T, Zaki S, Alam MF, Sharma S, Babkair RA, Nuhmani S, Pandita S. Effect of Whole-Body Vibration Exercise on Pain, Disability, Balance, Proprioception, Functional Performance and Quality of Life in People with Non-Specific Chronic Low Back Pain: A Systematic Review and Meta-Analysis. J Clin Med. 2024 Mar 13;13(6):1639. doi: 10.3390/jcm13061639.
- Background: PubMed 37752526Li Q, Liu P, Wang Z, Li X. Vibration therapy to improve pain and function in patients with chronic low back pain: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Sep 26;18(1):727. doi: 10.1186/s13018-023-04217-2.
- Background: PubMed 35278466Sungnak P, Songjaroen S, Krityakiarana W, Wang HK, Richards J, Wattananon P. Individuals With Impaired Lumbopelvic Control Demonstrate Lumbar Multifidus Muscle Activation Deficit Using Ultrasound Imaging in Conjunction With Electrical Stimulation: A Cross-sectional Study. Arch Phys Med Rehabil. 2022 Oct;103(10):1951-1957. doi: 10.1016/j.apmr.2022.02.010. Epub 2022 Mar 9.
- Background: PubMed 40238819Wattananon P, Kongoun S, Klahan K, Silfies SP, Gilliam JR, Richards J. Trunk kinematics and motor unit behavior during different loads and speeds in individuals with and without aberrant movement patterns during active forward bending: A cross-sectional study. PLoS One. 2025 Apr 16;20(4):e0321084. doi: 10.1371/journal.pone.0321084. eCollection 2025.
- Background: PubMed 37758911Wattananon P, Thu KW, Maharjan S, Sornkaew K, Wang HK. Cortical excitability and multifidus activation responses to transcranial direct current stimulation in patients with chronic low back pain during remission. Sci Rep. 2023 Sep 27;13(1):16242. doi: 10.1038/s41598-023-43597-7.
- Background: PubMed 38878816Masse-Alarie H, Shraim M, Hodges PW. Sensorimotor Integration in Chronic Low Back Pain. Neuroscience. 2024 Aug 6;552:29-38. doi: 10.1016/j.neuroscience.2024.06.008. Epub 2024 Jun 13.
- Background: PubMed 39061397Gilliam JR, Mandal D, Wattananon P, Banerjee S, Herter TM, Silfies SP. Vibration-Induced Alteration in Trunk Extensor Muscle Proprioception as a Model for Impaired Trunk Control in Low Back Pain. Brain Sci. 2024 Jun 28;14(7):657. doi: 10.3390/brainsci14070657.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications from this trial may be shared with qualified researchers upon reasonable request. Shared data may include de-identified clinical outcomes, adherence data, and processed mechanistic outcome data. Direct identifiers and information that could reasonably permit participant re-identification will not be shared. Data sharing will be subject to approval by the principal investigator and applicable Mahidol University and ethics requirements, and may require a data-use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peemongkon Wattananon, PhD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Sensory Stimulation Belt in people with Chronic Low Back Pain, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peemongkon Wattananon, PhD (+66-2-441-5450 ext. 21803, peemongkon.wat@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in low back pain intensity (time frame: Baseline and 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07801755, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.