Chronic Low Back PainLSS-OPTNCT07801729
Optimization of Lumbar Sensory Stimulation Parameters in Office Workers With Chronic Low Back Pain
A study testing Lumbar sensory stimulation in people with Chronic Low Back Pain, run by Mahidol University at 1 site in Thailand.
Trial 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. 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?
- Lumbar sensory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2027to 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 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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)
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: Effects of Different Lumbar Vibration Parameters on Somatosensory Cortical Responses in Office Workers With Chronic Nonspecific Low Back Pain: A Randomized Crossover Study
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.
Read the detailed description
Phase II is an experimental laboratory study designed to optimize the neurophysiological parameters of lumbar sensory stimulation in office workers with chronic nonspecific low back pain. The primary objective is to determine which combination of vibration frequency, amplitude, and direction produces the most favorable cortical response in the bilateral primary somatosensory cortex (S1), while meeting predefined safety, comfort, and technical criteria.
Participants will complete two laboratory visits separated by approximately 48-72 hours. The two visits have different purposes and are not intended to constitute a pre- and post-intervention comparison.
Visit 1: Baseline clinical and sensorimotor characterization During the first visit, participants will undergo clinical and neurophysiological assessments to characterize their baseline clinical and sensorimotor profiles. Clinical assessments will include pain intensity, low back pain-related disability, work-related musculoskeletal discomfort, movement-control testing, tactile acuity, and pressure pain threshold.
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 S1 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. Finally, lumbar multifidus morphology and contractile response will be assessed using rehabilitative ultrasound imaging (RUSI) at rest and during contralateral arm lifting.
The measurements obtained during Visit 1 are intended to characterize individual baseline sensorimotor function and to permit exploratory analyses of associations between clinical characteristics, corticospinal excitability, cortical responses, postural control, motor-unit behavior, lumbar multifidus contractile response, and responses to lumbar sensory stimulation. These measurements are not intended to serve as pre-intervention values for an acute pre-post comparison with Visit 2.
Visit 2: Randomized within-participant vibration-parameter optimization During the second visit, participants will undergo the vibration-fNIRS parameter-optimization experiment. Participants will lie prone in a relaxed position while an eight-channel fNIRS system records hemodynamic responses over the bilateral primary somatosensory cortex. A customized vibration apparatus will be positioned over the bilateral lumbar multifidus region.
Each participant will receive all eight vibration conditions generated from a 2 × 2 × 2 factorial combination of two vibration frequencies, two vibration amplitudes, and two stimulation directions. The order of the eight conditions will be randomized by computer for each participant to minimize systematic order effects. Randomization therefore applies to the sequence of stimulation conditions within each participant rather than allocation of participants to separate study arms.
Each vibration condition will be applied for 1 minute. A 5-minute passive rest period will be provided between successive vibration conditions to minimize fatigue and potential carryover effects and to allow the hemodynamic response to return toward baseline before the next condition.
The primary neurophysiological outcome will be the baseline-corrected change in oxygenated hemoglobin concentration (ΔHbO) in the bilateral S1 measured using fNIRS during each vibration condition. Secondary fNIRS outcomes will include changes in deoxygenated hemoglobin and total hemoglobin concentrations, peak oxygenated hemoglobin response, time to peak response, and area under the oxygenated hemoglobin response curve.
The effects of vibration frequency, amplitude, and direction, including their interactions, on the primary fNIRS outcome will be evaluated using a linear mixed-effects model with participant treated as a repeated or random effect. Condition order, testing period, baseline response, and preceding condition may be considered to evaluate potential sequence or carryover effects.
The optimal vibration parameters will not be selected solely on the basis of the largest cortical response. Parameter selection will integrate the magnitude and consistency of the bilateral S1 hemodynamic response with predefined criteria related to participant comfort, biomechanical safety, technical stability and performance of the stimulation apparatus, and suitability for subsequent incorporation into a wearable sensory stimulation belt. The selected parameters will subsequently be used in the Phase III randomized controlled trial.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lumbar sensory stimulation
- Keywords
- Chronic nonspecific low back pain, Lumbar vibration, Sensory stimulation, Somatosensory cortex, Functional near-infrared spectroscopy, Lumbar multifidus, Proprioception, Sensorimotor control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar sensory stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lumbar sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Deoxygenated hemoglobin concentration (ΔHHb) will be recorded from the bilateral primary somatosensory cortex using an eight-channel functional near-infrared spectroscopy (fNIRS) system. The outcome will be expressed as the baseline-corrected change in HHb during each lumbar vibration condition relative to the immediately preceding resting baseline
Measured: 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
Total hemoglobin concentration (ΔHbT), calculated from oxygenated and deoxygenated hemoglobin signals, will be recorded from the bilateral primary somatosensory cortex using fNIRS. The outcome will be expressed as the baseline-corrected change in HbT during each lumbar vibration condition
Measured: 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
The maximum baseline-corrected increase in oxygenated hemoglobin concentration (peak ΔHbO) within the predefined response window will be determined for each vibration condition. Left and right S1 responses may also be summarized separately and bilaterally
Measured: 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
The area under the curve (AUC) of the baseline-corrected oxygenated hemoglobin response will be calculated over the predefined response window for each vibration condition to quantify the magnitude and duration of the S1 hemodynamic response
Measured: 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
Corticospinal excitability will be assessed using single-pulse transcranial magnetic stimulation with surface EMG recording from the lumbar multifidus.
Measured: During Visit 1 of Phase II, prior to the vibration-parameter optimization session
Corticospinal excitability of the lumbar erector spinae measured by transcranial magnetic stimulation
Corticospinal excitability will be assessed using single-pulse transcranial magnetic stimulation with surface EMG recording from the lumbar erector spinae.
Measured: During Visit 1 of Phase II, prior to the vibration-parameter optimization session
Change in oxygenated hemoglobin concentration during unstable sitting
Cortical hemodynamic responses over the bilateral primary somatosensory cortex will be recorded using fNIRS during unstable sitting with eyes open and eyes closed.
Measured: During each sitting condition relative to the immediately preceding resting baseline in visit 1.
Postural-control response during unstable sitting
Postural-control behavior will be quantified during unstable sitting using inertial measurement units positioned at L1, S1, and the unstable chair.
Measured: During each vibration condition relative to the immediately preceding resting baseline in visit 1
Lumbar multifidus motor-unit behavior during loaded forward bending
Motor-unit behavior of the bilateral lumbar multifidus will be assessed using decomposition electromyography during repeated 45° trunk flexion-extension while holding a load equivalent to 5% of body weight.
Measured: During the loaded forward-bending assessment at baseline in Visit 1.
Lumbar multifidus contractile response measured by rehabilitative ultrasound imaging
Lumbar multifidus thickness will be measured at rest and during contralateral arm lifting using B-mode rehabilitative ultrasound imaging at the L4-L5 level.
Measured: During the baseline assessment in Visit 1
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 2027 (estimated)
- Primary completion31 Dec 2027 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT07801729
- Sponsor's protocol ID
- Sensory-Stimulation-Phase-II
- Acronym
- LSS-OPT
- Status last verified
- Aug 2026
- First submitted
- 25 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
- Undecided
Publications
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.
PubMed 33220931Koppenhaver 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.
PubMed 19154834Sungnak 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 40238819Masse-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.
PubMed 27847987Wattananon 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 37758911Franceschini 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.
PubMed 14570163Li 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.
PubMed 36816497Hamer 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.
PubMed 39644997Gilliam 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 39061397Masse-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 38878816
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
- Effects of Different Lumbar Vibration Parameters on Somatosensory Cortical Responses in Office Workers With Chronic Nonspecific Low Back Pain: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07801729
- Acronym / sponsor ID
- LSS-OPT / Sensory-Stimulation-Phase-II
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (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 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.
Detailed description
Phase II is an experimental laboratory study designed to optimize the neurophysiological parameters of lumbar sensory stimulation in office workers with chronic nonspecific low back pain. The primary objective is to determine which combination of vibration frequency, amplitude, and direction produces the most favorable cortical response in the bilateral primary somatosensory cortex (S1), while meeting predefined safety, comfort, and technical criteria.
Participants will complete two laboratory visits separated by approximately 48-72 hours. The two visits have different purposes and are not intended to constitute a pre- and post-intervention comparison.
Visit 1: Baseline clinical and sensorimotor characterization During the first visit, participants will undergo clinical and neurophysiological assessments to characterize their baseline clinical and sensorimotor profiles. Clinical assessments will include pain intensity, low back pain-related disability, work-related musculoskeletal discomfort, movement-control testing, tactile acuity, and pressure pain threshold.
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 S1 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. Finally, lumbar multifidus morphology and contractile response will be assessed using rehabilitative ultrasound imaging (RUSI) at rest and during contralateral arm lifting.
The measurements obtained during Visit 1 are intended to characterize individual baseline sensorimotor function and to permit exploratory analyses of associations between clinical characteristics, corticospinal excitability, cortical responses, postural control, motor-unit behavior, lumbar multifidus contractile response, and responses to lumbar sensory stimulation. These measurements are not intended to serve as pre-intervention values for an acute pre-post comparison with Visit 2.
Visit 2: Randomized within-participant vibration-parameter optimization During the second visit, participants will undergo the vibration-fNIRS parameter-optimization experiment. Participants will lie prone in a relaxed position while an eight-channel fNIRS system records hemodynamic responses over the bilateral primary somatosensory cortex. A customized vibration apparatus will be positioned over the bilateral lumbar multifidus region.
Each participant will receive all eight vibration conditions generated from a 2 × 2 × 2 factorial combination of two vibration frequencies, two vibration amplitudes, and two stimulation directions. The order of the eight conditions will be randomized by computer for each participant to minimize systematic order effects. Randomization therefore applies to the sequence of stimulation conditions within each participant rather than allocation of participants to separate study arms.
Each vibration condition will be applied for 1 minute. A 5-minute passive rest period will be provided between successive vibration conditions to minimize fatigue and potential carryover effects and to allow the hemodynamic response to return toward baseline before the next condition.
The primary neurophysiological outcome will be the baseline-corrected change in oxygenated hemoglobin concentration (ΔHbO) in the bilateral S1 measured using fNIRS during each vibration condition. Secondary fNIRS outcomes will include changes in deoxygenated hemoglobin and total hemoglobin concentrations, peak oxygenated hemoglobin response, time to peak response, and area under the oxygenated hemoglobin response curve.
The effects of vibration frequency, amplitude, and direction, including their interactions, on the primary fNIRS outcome will be evaluated using a linear mixed-effects model with participant treated as a repeated or random effect. Condition order, testing period, baseline response, and preceding condition may be considered to evaluate potential sequence or carryover effects.
The optimal vibration parameters will not be selected solely on the basis of the largest cortical response. Parameter selection will integrate the magnitude and consistency of the bilateral S1 hemodynamic response with predefined criteria related to participant comfort, biomechanical safety, technical stability and performance of the stimulation apparatus, and suitability for subsequent incorporation into a wearable sensory stimulation belt. The selected parameters will subsequently be used in the Phase III randomized controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vibration parameter | Experimental | Device: Lumbar sensory stimulationA 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. |
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 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Lumbar sensory stimulationA 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 | Vibration parameter |
Primary outcome
Change in oxygenated hemoglobin concentration in bilateral primary somatosensory cortex
Time frame: During each 1-minute vibration condition relative to its corresponding pre-stimulation baseline during the single Phase II parameter-optimization session.
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.
10 secondary outcomes
Change in deoxygenated hemoglobin concentration in the bilateral primary somatosensory cortex
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During Visit 1 of Phase II, prior to the vibration-parameter optimization session
Corticospinal excitability of the lumbar erector spinae measured by transcranial magnetic stimulation
Time frame: During Visit 1 of Phase II, prior to the vibration-parameter optimization session
Change in oxygenated hemoglobin concentration during unstable sitting
Time frame: During each sitting condition relative to the immediately preceding resting baseline in visit 1.
Postural-control response during unstable sitting
Time frame: During each vibration condition relative to the immediately preceding resting baseline in visit 1
Lumbar multifidus motor-unit behavior during loaded forward bending
Time frame: During the loaded forward-bending assessment at baseline in Visit 1.
Lumbar multifidus contractile response measured by rehabilitative ultrasound imaging
Time frame: During the baseline assessment in Visit 1
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 33220931Wattananon 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.
- Background: PubMed 19154834Koppenhaver 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.
- 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 27847987Masse-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.
- 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 14570163Franceschini 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.
- Background: PubMed 36816497Li 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.
- Background: PubMed 39644997Hamer 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.
- 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.
- 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.
- Individual participant dataSharing planned: Undecided
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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 Lumbar sensory stimulation 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. 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 oxygenated hemoglobin concentration in bilateral primary somatosensory cortex (time frame: During each 1-minute vibration condition relative to its corresponding pre-stimulation baseline during the single Phase II parameter-optimization session.). 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 NCT07801729, 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.