Movement Control and Motor Unit Behavior Responses to Different Types of Stimulation
NCT Number: NCT06516770
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: DEVICE: Transcranial direct current stimulation|DEVICE: Neuromuscular electrical stimulation|OTHER: Motor control exercise|OTHER: Isometric exercise
Sponsor: Mahidol University
Sex: ALL
Age: ADULT
Enrollment: 136
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12
Locations: Faculty of Physical Therapy, Mahidol University, Salaya, Nakhon Pathom, 73170, Thailand

Summary:
This study aims to determine the effect of different stimulations including 1) transcranial direct current stimulation (tDCS), 2) neuromuscular electrical stimulation (NMES), 3) motor control exercise (MCE), and 4) isometric exercise (IE) on movement control and motor unit behavior in individuals with movement control impairment, and determine the correlation between movement control and motor unit behavior.

Primary Outcome Measures: Segmental angular velocity in degrees/second, Segmental angular velocity will be derived from the inertial measurement units., baseline and immediately after the intervention|Clinical observation, Clinical observation rating will be recorded as presence or absence of aberrant movement by two raters., baseline and immediately after the intervention|Number of motor units, Number of motor units will be derived from decomposition of muscle activity using electromyography system., baseline and immediately after the intervention|Motor unit action potential in millivolts, Motor unit action potential will be derived from decomposition of muscle activity using electromyography system., baseline and immediately after the intervention|Motor unit firing rate in pulses/second, Motor unit firing rate will be derived from decomposition of muscle activity using electromyography system., baseline and immediately after the intervention
Secondary Outcome Measures: Pain intensity, Pain intensity will be evaluated using numeric pain rating scale. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable"., baseline|Level of disability in percentage, Level of disability will be evaluated using modified Oswestry Disability Questionnaire. Questionnaire examines the level of disability in 10 everyday activities of daily living. Each item consist of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability., baseline|Fear of movement level, Fear of movement will be evaluated using Tampa Scale for Kinesiophobia. The 17-item Tampa Scale for Kinesiophobia total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia., baseline|Perception of change, Perception of change will be evaluated using a Global Rating of Change Questionnaire. It is composed of a scale (-4 to +4) that assesses whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change after exercise. In the middle of the response scale is a "0" indicating no improvement or no change, the negative values towards the left indicate worsening symptoms or a deterioration in status, and positive values towards the right indicate improvement in the health status., immediately after the intervention