Movement Control and Motor Unit Behavior Responses to Different Types of Stimulation

NCT06516770 | Enrolling By Invitation

• 1 other identifier: MU-CIRB 2022/118.0711
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

Transcranial direct current stimulation; Neuromuscular electrical stimulation; Motor control exercise; Isometric exercise; Motor unit behavior; Movement control; Lumbar multifidus muscle

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Pain intensity

  baseline

• Level of disability in percentage

  baseline

• Fear of movement level

  baseline

• Perception of change

  immediately after the intervention

Study Arms (4)

Transcranial direct current stimulation

EXPERIMENTAL

The subject will receive transcranial direct current stimulation for 20 minutes.

Device: Transcranial direct current stimulation

Neuromuscular electrical stimulation

EXPERIMENTAL

The subject will receive neuromuscular electrical stimulation for 20 minutes.

Device: Neuromuscular electrical stimulation

Motor control exercise

EXPERIMENTAL

The subject will receive motor control exercise for 20 minutes.

Other: Motor control exercise

Isometric exercise

ACTIVE COMPARATOR

The subject will receive isometric exercise for 20 minutes.

Other: Isometric exercise

Interventions

Transcranial direct current stimulation DEVICE

The subject will receive the tDCS using 5X7 cm electrodes. The anodal electrode will be placed on M1 representing the back muscles (1 cm anterior and 4 cm lateral to the vertex), while cathodal electrode will be placed on contralateral supraorbital area. The intensity will be set at 2 mA with 10-second fade in/out. The subject will be stimulated by tDCS for 20 minutes

Transcranial direct current stimulation

Neuromuscular electrical stimulation DEVICE

The participants will receive the NMES using interferential mode (6000 Hz, beat frequency 20-50 Hz, scanning effect) on bilateral LM. The intensity will be set at the subject's maximum tolerance. Stimulation will be set at 10 seconds on and 60 seconds off to minimize muscle fatigue. The total NMES time is 20 minutes.

Neuromuscular electrical stimulation

Motor control exercise OTHER

The participant will be instructed to perform co-contraction of transverse abdominis and lumbar multifidus muscle, while performing self-selected pace forward bend. Emphasis will be given to move in control manner (smooth and symmetrical movement). The participant will perform 4 minutes of continuous movement for 4 sets with 1 minute rest between sets.

Motor control exercise

Isometric exercise OTHER

The participant will be instructed to perform isometric back extension exercise in modified Sorensen position. The participant will hold 60 seconds in neutral position for 5 repetitions with 3 minutes rest between repetitions.

Isometric exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 40
• Both male and female
• Presence of movement control impairment (instability catch during clinical observation of active forward bend test)
• No current episode of low back pain
• No definitive neurologic signs including weakness or numbness in the lower extremity
• No previous spinal surgery
• Have not been diagnosed osteoporosis, severe spinal stenosis, inflammatory joint disease, and/or systemic disease
• Body mass index (BMI) less than 30 kg/m2

You may not qualify if:

• Pregnancy
• Any lower extremity condition that would potentially alter trunk movement in standing
• Vestibular dysfunction
• Extreme psychosocial involvement
• Active treatment of another medical illness that would preclude participation in any aspect of the study
• Contraindication for tDCS including a history of head injury/surgery, seizure, cardiac pacemaker, metal/electrical/magnetic implantation, uncontrolled migraine headache

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

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MeSH Terms

Conditions

Low Back Pain

Interventions

Transcranial Direct Current Stimulation; Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Peemongkon Wattananon, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 24, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

TH (1)