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Low Back PainNCT06516770

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

A study testing Transcranial direct current stimulation, Neuromuscular electrical stimulation and Isometric exercise in people with Low Back Pain, run by Mahidol University at 1 site in Thailand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Transcranial direct current stimulation, Neuromuscular electrical stimulation and Isometric exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteThailand
Study dates
1 Jul 2024to 31 Dec 2026
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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Faculty of Physical Therapy, Mahidol University

    Salaya, Changwat Nakhon Pathom, 73170

Other trials in Thailand

About this study

Official title: The Effects of Different Types of Stimulation on Movement Control and Motor Unit Behavior in Individuals With Lumbopelvic Movement Control Impairment

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.

Read the detailed description

After obtaining the written informed consent, all participants will fill out the information sheet for demographic data. Data collection will be conducted in private laboratory with closed environment. Only lab staffs can access to the lab. Female researchers will perform participant preparation. Participants will be informed that they have to change their cloth to lab tank top to expose their lower back area. However, they can decline to change their cloth. In this case, researchers will fold their cloth to expose the lower back. The body landmarks will be identified. These landmarks include 1) spinous processes (L1 and S1 levels), 2) lumbar multifidus (LM) (2 cm lateral to lower half of L4 spinous process), 3) bilateral lateral epicondyle of femur, and 4) bilateral lateral malleolus. Spinous process of L1, S2, bilateral lateral epicondyle of femur, and bilateral lateral malleolus will be used as locations for inertial measurement unit (IMU) sensors, while LM location will be used to place surface electrode for decomposition electromyography (dEMG). This preparation process will take about 20 minutes.

The participant will be asked to perform 1-minute active forward bend based on speed and load that can differentiate between healthy individuals and individuals with movement control impairment. IMU and dEMG data are concurrently collected. Five-minute rest will be provided to avoid muscle fatigue. After that, participant will be randomly assigned to one of four stimulations including transcranial direct current stimulation (tDCS), neuromuscular electrical stimulation (NMES), isometric exercise (IE), and motor control exercise (MCE). Each stimulation will take approximately 20 minutes.

Types of stimulation Transcranial direct current stimulation (tDCS): The participant 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.

Neuromuscular electrical stimulation (NMES): 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.

Isometric exercise (IE): 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.

Movement control exercise (MCE): 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. This exercise is low intensity focusing on control of movement; therefore, the occurrence of muscle fatigue is unlikely.

After completion of one session stimulation, the participant will be asked to perform 1-minute active forward bend with the same speed and load again, while IMU and dEMG data will be simultaneously corrected. IMU data will be used to determine the effect of stimulation (tDCS, NMES, IE, and MCE) on movement control in individuals with movement control impairment. dEMG data will be used to determine the effect of each stimulation on motor unit behavior (spatial and temporal motor unit recruitment). In addition, IMU and dEMG data will be further used to determine the association between movement control and motor unit behavior. Data collection including 20-minute stimulation will take approximately 30 minutes.

Conditions
Low Back Pain
Being tested
Transcranial direct current stimulation, Neuromuscular electrical stimulation, Motor control exercise, Isometric exercise
Keywords
Transcranial direct current stimulation, Neuromuscular electrical stimulation, Motor control exercise, Isometric exercise, Motor unit behavior, Movement control, Lumbar multifidus muscle
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulationDevice

    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

  • Neuromuscular electrical stimulationDevice

    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.

  • Motor control exerciseOther

    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.

  • Isometric exerciseOther

    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.

Study groups in NCT06516770
Study groupRoleWhat they receive
Transcranial direct current stimulationExperimentalThe subject will receive transcranial direct current stimulation for 20 minutes.
Receives: Device: Transcranial direct current stimulation
Neuromuscular electrical stimulationExperimentalThe subject will receive neuromuscular electrical stimulation for 20 minutes.
Receives: Device: Neuromuscular electrical stimulation
Motor control exerciseExperimentalThe subject will receive motor control exercise for 20 minutes.
Receives: Other: Motor control exercise
Isometric exerciseActive comparatorThe subject will receive isometric exercise for 20 minutes.
Receives: Other: Isometric exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Segmental angular velocity in degrees/second

    Segmental angular velocity will be derived from the inertial measurement units.

    Measured: baseline and immediately after the intervention

  2. Clinical observation

    Clinical observation rating will be recorded as presence or absence of aberrant movement by two raters.

    Measured: baseline and immediately after the intervention

  3. Number of motor units

    Number of motor units will be derived from decomposition of muscle activity using electromyography system.

    Measured: baseline and immediately after the intervention

  4. Motor unit action potential in millivolts

    Motor unit action potential will be derived from decomposition of muscle activity using electromyography system.

    Measured: baseline and immediately after the intervention

  5. Motor unit firing rate in pulses/second

    Motor unit firing rate will be derived from decomposition of muscle activity using electromyography system.

    Measured: baseline and immediately after the intervention

Secondary outcomes (4)
  1. 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".

    Measured: baseline

  2. 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.

    Measured: baseline

  3. 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.

    Measured: baseline

  4. 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.

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516770
Sponsor's protocol ID
MU-CIRB 2022/118.0711
Status last verified
May 2026
First submitted
8 Jul 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.

    PubMed 16181938
  • O'Sullivan P. Diagnosis and classification of chronic low back pain disorders: maladaptive movement and motor control impairments as underlying mechanism. Man Ther. 2005 Nov;10(4):242-55. doi: 10.1016/j.math.2005.07.001. Epub 2005 Sep 9.

    PubMed 16154380
  • Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.

    PubMed 29097026
  • Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.

    PubMed 31151377
  • Panjabi MM. Clinical spinal instability and low back pain. J Electromyogr Kinesiol. 2003 Aug;13(4):371-9. doi: 10.1016/s1050-6411(03)00044-0.

    PubMed 12832167
  • Reeves NP, Cholewicki J, van Dieen JH, Kawchuk G, Hodges PW. Are Stability and Instability Relevant Concepts for Back Pain? J Orthop Sports Phys Ther. 2019 Jun;49(6):415-424. doi: 10.2519/jospt.2019.8144. Epub 2019 Apr 25.

    PubMed 31021689
  • van Dieen JH, Reeves NP, Kawchuk G, van Dillen LR, Hodges PW. Motor Control Changes in Low Back Pain: Divergence in Presentations and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):370-379. doi: 10.2519/jospt.2019.7917. Epub 2018 Jun 12.

    PubMed 29895230
  • Biely SA, Silfies SP, Smith SS, Hicks GE. Clinical observation of standing trunk movements: what do the aberrant movement patterns tell us? J Orthop Sports Phys Ther. 2014 Apr;44(4):262-72. doi: 10.2519/jospt.2014.4988. Epub 2014 Jan 22.

    PubMed 24450372
  • Kong-Oun S, Prasertkul W, Fungkiatphaiboon P, Wattananon P. The inter-rater reliability of clinical observation of prone hip extension and association between aberrant movement and chronic low back pain. Musculoskelet Sci Pract. 2022 Feb;57:102476. doi: 10.1016/j.msksp.2021.102476. Epub 2021 Nov 6.

    PubMed 34768224
  • Luomajoki H, Kool J, de Bruin ED, Airaksinen O. Movement control tests of the low back; evaluation of the difference between patients with low back pain and healthy controls. BMC Musculoskelet Disord. 2008 Dec 24;9:170. doi: 10.1186/1471-2474-9-170.

    PubMed 19108735
  • Wattananon P, Ebaugh D, Biely SA, Smith SS, Hicks GE, Silfies SP. Kinematic characterization of clinically observed aberrant movement patterns in patients with non-specific low back pain: a cross-sectional study. BMC Musculoskelet Disord. 2017 Nov 15;18(1):455. doi: 10.1186/s12891-017-1820-x.

    PubMed 29141615
  • Laird RA, Kent P, Keating JL. Modifying patterns of movement in people with low back pain -does it help? A systematic review. BMC Musculoskelet Disord. 2012 Sep 7;13:169. doi: 10.1186/1471-2474-13-169.

    PubMed 22958597
  • Khobkhun F, Hollands MA, Richards J, Ajjimaporn A. Can We Accurately Measure Axial Segment Coordination during Turning Using Inertial Measurement Units (IMUs)? Sensors (Basel). 2020 Apr 29;20(9):2518. doi: 10.3390/s20092518.

    PubMed 32365573
  • Seel T, Raisch J, Schauer T. IMU-based joint angle measurement for gait analysis. Sensors (Basel). 2014 Apr 16;14(4):6891-909. doi: 10.3390/s140406891.

    PubMed 24743160
  • Hodges PW, Coppieters MW, MacDonald D, Cholewicki J. New insight into motor adaptation to pain revealed by a combination of modelling and empirical approaches. Eur J Pain. 2013 Sep;17(8):1138-46. doi: 10.1002/j.1532-2149.2013.00286.x. Epub 2013 Jan 25.

    PubMed 23349066

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation, Neuromuscular electrical stimulation and Isometric exercise in people with 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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 May 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Segmental angular velocity in degrees/second (time frame: baseline and immediately after the intervention). The study lists 5 primary outcomes in all. 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 NCT06516770, which also lists 29 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 13 May 2026.

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