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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Vibration parameterExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

Time frame
During each vibration condition relative to the immediately preceding resting baseline during the Phase II parameter-optimization session
2

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

Time frame
During each vibration condition relative to the immediately preceding resting baseline during the Phase II parameter-optimization session
3

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

Time frame
During each vibration condition relative to the immediately preceding resting baseline during the Phase II parameter-optimization session
4

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

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

Other outcomes

Sponsors and contacts

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