Sensory Stimulation Belt for Chronic Low Back Pain in Office Workers

NCT07801755 | Not Yet Recruiting

• 1 other identifier: Sensory-Stimulation-Phase-III
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Low Back Pain

Keywords

Chronic nonspecific low back pain; Office workers; Sensory stimulation; Lumbar vibration; Wearable device; Lumbar multifidus; Sensorimotor control; Somatosensory cortex; Proprioception

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline and 4 weeks

Secondary Outcomes (16)

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

  Baseline and 4 weeks

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

  Baseline and 4 weeks

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

  Baseline and 4 weeks

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

  Baseline and 4 weeks

• Change in cortical motor map area of lumbar multifidus and erector spinae

  Baseline and 4 weeks

Study Arms (2)

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.

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.

Device: Sham Sensory Stimulation Belt

Interventions

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.

Active Sensory Stimulation Belt

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.

Sham Sensory Stimulation Belt

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (11)

• 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.

  PMID: 26022102 BACKGROUND

• Park 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.

  PMID: 36316867 BACKGROUND

• del 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.

  PMID: 21687923 BACKGROUND

• Tariq 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.

  PMID: 38205229 BACKGROUND

• Zafar 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.

  PMID: 38541865 BACKGROUND

• Li 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.

  PMID: 37752526 BACKGROUND

• Sungnak 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.

  PMID: 35278466 BACKGROUND

• Wattananon 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.

  PMID: 40238819 BACKGROUND

• Wattananon 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.

  PMID: 37758911 BACKGROUND

• Masse-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.

  PMID: 38878816 BACKGROUND

• Gilliam 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.

  PMID: 39061397 BACKGROUND

Study Officials

• Peemongkon Wattananon, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peemongkon Wattananon, PhD

CONTACT

+66-2-441-5450; peemongkon.wat@mahidol.ac.th

Apinkarn Jaroenlarp, PhD Candidate

CONTACT

+66-89-329-6194; j.apinkarn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. The active and sham belts will be designed to have similar appearance, weight, sound, and user interface. Device allocation and programming will be performed by research personnel who are not involved in outcome assessment. The sham belt will provide a brief, low-level surface vibration at the beginning of use but will not provide the sustained stimulation delivered by the active belt.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 6 months after publication of the primary trial results and will remain available for 5 years after publication.
• Access Criteria: Qualified researchers may request access by submitting a written proposal to the principal investigator describing the research question, requested variables, analysis plan, and intended use of the data. Requests will be reviewed for scientific merit, ethical appropriateness, participant confidentiality, and compatibility with the original informed consent. Approved requests may require execution of a data-use agreement before de-identified data are provided.

Locations

TH (1)