Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain.

NCT05156242 | Completed

• 1 other identifier: MU-CIRB 2021/327.2906
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to 1) determine the immediate effects of transcranial direct current stimulation (tDCS) on corticospinal excitability, lumbar multifidus muscle (LM) activation, as well as lumbar stability in patients with chronic low back pain (CLBP), 2) determine the immediate effects of neuromuscular electrical stimulation (NMES) on corticospinal excitability, LM activation, as well as lumbar stability in patients with CLBP, 3) compare the effectiveness of 6-week intervention program among tDCS priming with motor control exercise (MCE), NMES priming with MCE, and MCE alone in patients with CLBP, and 4) determine the associations among corticospinal excitability, LM activation, lumbar stability, movement patterns, and clinical outcomes in patients with CLBP.

Conditions

Low Back Pain

Keywords

Low back pain; Corticospinal excitability; Transcranial magnetic stimulation; Transcranial direct current stimulation; Neuromuscular electrical stimulation; Motor control exercise; Lumbar multifidus muscle

Outcome Measures

Primary Outcomes (5)

• Corticospinal excitability measurement

  Transcranial magnetic stimulation (TMS) will be used to measure corticospinal excitability including resting and active motor thresholds, motor evoke potentials, cortical silent period of LM, and topography (center of gravity coordinate; CoG and volume) of ES and LM, will be primary outcomes for objectives 1-4.

  Change from baseline after 1 session and at 6 week after intervention.

• Muscle function measurement

  Ultrasound imaging will be used to measure muscle function including TrA and LM thickness, cross-sectional area, and pennation angle will be primary outcome for objective 1-4.

  Change from baseline after 1 session and at 6 week after intervention.

• Lumbar stability measurement

  Electromagnetic tracking system will be used to measure spinal displacement during applying compression force to represent lumbar stability. This will be primary outcome measures for objective 1-4.

  Change from baseline after 1 session and at 6 week after intervention.

• Kinematic measurement

  Inertial measurement unit will be used to measure lumbopelvic motions during functional and clinical movement tests. These data can represent movement control. These data will be primary outcome for objectives 3 and 4.

  Change from baseline at 6 week after intervention.

• Clinical observation of aberrant movement

  Clinician will observe the movements and rate as presence or absence of aberrant movement.

  Change from baseline at 6 week after intervention.

Secondary Outcomes (2)

• Self-report questionnaires

  Change from baseline at 6 week after intervention.

• Functional capacity

  Change from baseline at 6 week after intervention.

Study Arms (4)

Active-tDCS priming MCE

EXPERIMENTAL

The subjects in active-tDCS priming with MCE group will receive the tDCS using 5X7 cm electrodes in which 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. After that, the subjects will receive 20-minute MCE.

Device: Active-tDCS priming MCE

Sham-tDCCS priming MCE

SHAM COMPARATOR

The subjects in sham-tDCS priming with MCE group will receive a 20-minute sham tDCS by setting the intensity at zero mA. After that, the subjects will receive 20-minute MCE.

Device: Sham-tDCS priming MCE

NMES priming MCE

ACTIVE COMPARATOR

The subjects in NMES priming with MCE group 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. After that, the subjects will receive 20-minute MCE.

Device: NMES priming MCE

Conventional physical therapy

ACTIVE COMPARATOR

The subjects in conventional physical therapy group will receive physical therapy modality (e.g., ultrasound, TENS, etc.) and general exercises.

Other: Conventional physical therapy

Interventions

Active-tDCS priming MCE DEVICE

tDCS is used to enhance cortical excitability before motor control exercises.

Also known as: MINDD STIM, Ybrain Inc., Korea

Active-tDCS priming MCE

Sham-tDCS priming MCE DEVICE

tDCS will be set at 0 mA for 20 minutes before motor control exercise.

Also known as: MINDD STIM, Ybrain Inc., Korea

Sham-tDCCS priming MCE

NMES priming MCE DEVICE

NMES is used to enhance lumbar multifidus motor unit recruitment before motor control exercise.

Also known as: Sonopuls-490 combination therapy, Enraf-Nonius BV, The Netherlands

NMES priming MCE

Conventional physical therapy OTHER

Conventional physical therapy includes modality for pain control, general exercise to improve muscle strength, endurance, and flexibility, and functional training (sit to stand, walking, etc.).

Conventional physical therapy

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
• No previous history of low back pain in lifetime.
• Between the ages of 18 and 40.
• Having low back pain over 3 months or a recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment. This information will be obtained by interview during subjective examination.

You may not qualify if:

• History of seizure for either the subject or any family member
• Implanted pacemaker
• Clinical signs of systemic disease
• Definitive neurologic signs including pain, weakness or numbness in the lower extremity
• Previous spinal surgery
• Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
• Any lower extremity condition that would potentially alter trunk movement
• Vestibular dysfunction
• Extreme psychosocial involvement
• Body mass index (BMI) greater than 30 kg/m2
• Active treatment of another medical illness that would preclude participation in any aspect of the study
• Menstruation or pregnancy (for female subject)
• Diagnosed herniated nucleus pulposus (HNP)
• Contraindications for TMS and tDCS including open wound, infection, lesions, arteriosclerosis, history of haemophilia or demand-type pacemaker
• Acute cerebral hemorrhage

Sponsors & Collaborators

• Mahidol University: lead
• University of South Carolina: collaborator

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (34)

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Peemongkon Wattananon

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant will be blinded using active vs sham intervention. Care provider is not involving in data collection and blinded to type of stimulation. Outcomes assessor will be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 4-arm randomized controlled trial (active-tDCS priming MCE, sham-tDCS priming MCE, NMES priming MCE, and conventional physical therapy)

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: September 3, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After December 2022 for 5 years.
• Access Criteria: Written request will be reviewed by principal investigator.

Locations

TH (1)