Optimization of Lumbar Sensory Stimulation Parameters in Office Workers With Chronic Low Back Pain

NCT07801729 | Not Yet Recruiting

• 1 other identifier: Sensory-Stimulation-Phase-II
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the optimal parameters of lumbar sensory stimulation in office workers with chronic nonspecific low back pain. Participants will attend two laboratory sessions. The first session will characterize baseline clinical and sensorimotor function using clinical assessments, transcranial magnetic stimulation, functional near-infrared spectroscopy during unstable sitting, inertial measurement units, decomposition electromyography, and rehabilitative ultrasound imaging. The second session will use a randomized within-participant crossover design in which participants receive eight combinations of lumbar vibration frequency, amplitude, and direction while bilateral primary somatosensory cortex hemodynamic responses are continuously measured using functional near-infrared spectroscopy. The primary objective is to identify vibration parameters that produce a favorable and consistent cortical response while meeting predefined comfort, safety, and technical criteria.

Conditions

Chronic Low Back Pain

Keywords

Chronic nonspecific low back pain; Lumbar vibration; Sensory stimulation; Somatosensory cortex; Functional near-infrared spectroscopy; Lumbar multifidus; Proprioception; Sensorimotor control

Outcome Measures

Primary Outcomes (1)

• Change in oxygenated hemoglobin concentration in bilateral primary somatosensory cortex

  Baseline-corrected change in oxygenated hemoglobin concentration (ΔHbO) recorded from the bilateral primary somatosensory cortex using an eight-channel functional near-infrared spectroscopy system during lumbar vibration.

  During each 1-minute vibration condition relative to its corresponding pre-stimulation baseline during the single Phase II parameter-optimization session.

Secondary Outcomes (10)

• Change in deoxygenated hemoglobin concentration in the bilateral primary somatosensory cortex

  During each vibration condition relative to the immediately preceding resting baseline during the Phase II parameter-optimization session

• Change in total hemoglobin concentration in the bilateral primary somatosensory cortex

  During each vibration condition relative to the immediately preceding resting baseline during the Phase II parameter-optimization session

• Peak oxygenated hemoglobin response in the bilateral primary somatosensory cortex

  During each vibration condition relative to the immediately preceding resting baseline during the Phase II parameter-optimization session

• Area under the oxygenated hemoglobin response curve in the bilateral primary somatosensory cortex

  During each vibration condition relative to the immediately preceding resting baseline during the Phase II parameter-optimization session

• Corticospinal excitability of the lumbar multifidus measured by transcranial magnetic stimulation

  During Visit 1 of Phase II, prior to the vibration-parameter optimization session

Study Arms (1)

Vibration parameter

EXPERIMENTAL

A customized vibration apparatus will deliver controlled mechanical stimulation over the bilateral lumbar multifidus region. Participants will receive eight randomized combinations of vibration frequency, amplitude, and direction. Each condition will be delivered for 1 minute, followed by a 5-minute passive rest period.

Device: Lumbar sensory stimulation

Interventions

Lumbar sensory stimulation DEVICE

A customized vibration apparatus will deliver controlled mechanical stimulation over the bilateral lumbar multifidus region. Participants will receive eight randomized combinations of vibration frequency, amplitude, and direction. Each condition will be delivered for 1 minute, followed by a 5-minute passive rest period.

Vibration parameter

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 20-60 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 for either the subject or any family member
• Implanted pacemaker
• Contraindications for TMS and fNIRS, including open wound, infection, lesions, arteriosclerosis, history of hemophilia, or demand-type pacemaker
• Acute cerebral hemorrhage
• History of major spinal surgery, fracture, or traumatic injury to the lumbar spine.
• Evidence of neurological deficits (e.g., radiculopathy, loss of sensation, or motor weakness in lower limbs).
• Diagnosis of systemic inflammatory conditions (e.g., Ankylosing Spondylitis, Rheumatoid Arthritis).
• Allergy to adhesives or history of severe skin sensitivity to vibration/mechanical pressure.
• Body Mass Index (BMI) \> 30 kg/m2 (to ensure clarity of RUSI, dEMG, and fNIRs signal quality).
• Pregnancy (due to changes in spinal biomechanics and hormones)

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (11)

• Wattananon P, Sungnak P, Songjaroen S, Kantha P, Hsu WL, Wang HK. Using neuromuscular electrical stimulation in conjunction with ultrasound imaging technique to investigate lumbar multifidus muscle activation deficit. Musculoskelet Sci Pract. 2020 Dec;50:102215. doi: 10.1016/j.msksp.2020.102215. Epub 2020 Jul 13.

  PMID: 33220931 BACKGROUND

• Koppenhaver SL, Hebert JJ, Fritz JM, Parent EC, Teyhen DS, Magel JS. Reliability of rehabilitative ultrasound imaging of the transversus abdominis and lumbar multifidus muscles. Arch Phys Med Rehabil. 2009 Jan;90(1):87-94. doi: 10.1016/j.apmr.2008.06.022.

  PMID: 19154834 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

• Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. The side of chronic low back pain matters: evidence from the primary motor cortex excitability and the postural adjustments of multifidi muscles. Exp Brain Res. 2017 Mar;235(3):647-659. doi: 10.1007/s00221-016-4834-y. Epub 2016 Nov 15.

  PMID: 27847987 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

• Franceschini MA, Fantini S, Thompson JH, Culver JP, Boas DA. Hemodynamic evoked response of the sensorimotor cortex measured noninvasively with near-infrared optical imaging. Psychophysiology. 2003 Jul;40(4):548-60. doi: 10.1111/1469-8986.00057.

  PMID: 14570163 BACKGROUND

• Li Y, Xu Z, Xie H, Fu R, Lo WLA, Cheng X, Yang J, Ge L, Yu Q, Wang C. Changes in cortical activation during upright stance in individuals with chronic low back pain: An fNIRS study. Front Hum Neurosci. 2023 Feb 3;17:1085831. doi: 10.3389/fnhum.2023.1085831. eCollection 2023.

  PMID: 36816497 BACKGROUND

• Hamer S, Curcic-Blake B, van der Zee EA, van Heuvelen MJG. The acute effects of whole-body vibration exercise on cortical activation in young adults: An fNIRS study. Behav Brain Res. 2025 Mar 5;480:115381. doi: 10.1016/j.bbr.2024.115381. Epub 2024 Dec 5.

  PMID: 39644997 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

• 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

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will undergo the same two-session study protocol. During the vibration-parameter optimization session, each participant will receive all eight combinations of vibration frequency, amplitude, and direction. The order of the eight vibration conditions will be randomized by computer for each participant to minimize order and carryover effects. Thus, randomization applies to the within-participant sequence of vibration conditions rather than allocation of participants to separate study arms.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

TH (1)