Movement Control and Motor Unit Behavior Responses to Different Types of Stimulation
NCT ID: NCT06516770
Last Updated: 2024-07-24
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
NA
136 participants
INTERVENTIONAL
2024-07-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Transcranial direct current stimulation
The subject will receive transcranial direct current stimulation for 20 minutes.
Transcranial direct current stimulation
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 stimulation
The subject will receive neuromuscular electrical stimulation for 20 minutes.
Neuromuscular electrical stimulation
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 exercise
The subject will receive motor control exercise for 20 minutes.
Motor control exercise
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 exercise
The subject will receive isometric exercise for 20 minutes.
Isometric exercise
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.
Interventions
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Transcranial direct current stimulation
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 stimulation
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 exercise
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 exercise
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.
Eligibility Criteria
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Inclusion Criteria
2. Both male and female
3. Presence of movement control impairment (instability catch during clinical observation of active forward bend test)
4. No current episode of low back pain
5. No definitive neurologic signs including weakness or numbness in the lower extremity
6. No previous spinal surgery
7. Have not been diagnosed osteoporosis, severe spinal stenosis, inflammatory joint disease, and/or systemic disease
8. Body mass index (BMI) less than 30 kg/m2
Exclusion Criteria
2. Any lower extremity condition that would potentially alter trunk movement in standing
3. Vestibular dysfunction
4. Extreme psychosocial involvement
5. Active treatment of another medical illness that would preclude participation in any aspect of the study
6. Contraindication for tDCS including a history of head injury/surgery, seizure, cardiac pacemaker, metal/electrical/magnetic implantation, uncontrolled migraine headache
18 Years
40 Years
ALL
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Peemongkon Wattananon
Associate Professor
Principal Investigators
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Peemongkon Wattananon, PhD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Wattananon P, Silfies SP, Tretriluxana J, Jalayondeja W. Lumbar Multifidus and Erector Spinae Muscle Synergies in Patients with Nonspecific Low Back Pain During Prone Hip Extension: A Cross-sectional Study. PM R. 2019 Jul;11(7):694-702. doi: 10.1002/pmrj.12002. Epub 2019 Feb 27.
Wattananon P, Sinsurin K, Somprasong S. Association between lumbopelvic motion and muscle activation in patients with non-specific low back pain during forward bending task: A cross-sectional study. Hong Kong Physiother J. 2020 Jun;40(1):29-37. doi: 10.1142/S1013702520500043. Epub 2019 Dec 30.
De Luca CJ. Control properties of motor units. J Exp Biol. 1985 Mar;115:125-36. doi: 10.1242/jeb.115.1.125.
De Luca CJ, Contessa P. Biomechanical benefits of the Onion-Skin motor unit control scheme. J Biomech. 2015 Jan 21;48(2):195-203. doi: 10.1016/j.jbiomech.2014.12.003. Epub 2014 Dec 9.
Merletti R, Knaflitz M, DeLuca CJ. Electrically evoked myoelectric signals. Crit Rev Biomed Eng. 1992;19(4):293-340.
De Luca CJ, Chang SS, Roy SH, Kline JC, Nawab SH. Decomposition of surface EMG signals from cyclic dynamic contractions. J Neurophysiol. 2015 Mar 15;113(6):1941-51. doi: 10.1152/jn.00555.2014. Epub 2014 Dec 24.
Nawab SH, Chang SS, De Luca CJ. High-yield decomposition of surface EMG signals. Clin Neurophysiol. 2010 Oct;121(10):1602-15. doi: 10.1016/j.clinph.2009.11.092. Epub 2010 Apr 28.
Silva MF, Dias JM, Pereira LM, Mazuquin BF, Lindley S, Richards J, Cardoso JR. Determination of the motor unit behavior of lumbar erector spinae muscles through surface EMG decomposition technology in healthy female subjects. Muscle Nerve. 2017 Jan;55(1):28-34. doi: 10.1002/mus.25184. Epub 2016 Nov 1.
Doucet BM, Lam A, Griffin L. Neuromuscular electrical stimulation for skeletal muscle function. Yale J Biol Med. 2012 Jun;85(2):201-15. Epub 2012 Jun 25.
Mariano TY, Burgess FW, Bowker M, Kirschner J, Van't Wout-Frank M, Jones RN, Halladay CW, Stein M, Greenberg BD. Transcranial Direct Current Stimulation for Affective Symptoms and Functioning in Chronic Low Back Pain: A Pilot Double-Blinded, Randomized, Placebo-Controlled Trial. Pain Med. 2019 Jun 1;20(6):1166-1177. doi: 10.1093/pm/pny188.
Nussbaum EL, Houghton P, Anthony J, Rennie S, Shay BL, Hoens AM. Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Physiother Can. 2017;69(5):1-76. doi: 10.3138/ptc.2015-88.
Songjaroen S, Sungnak P, Piriyaprasarth P, Wang HK, Laskin JJ, Wattananon P. Combined neuromuscular electrical stimulation with motor control exercise can improve lumbar multifidus activation in individuals with recurrent low back pain. Sci Rep. 2021 Jul 20;11(1):14815. doi: 10.1038/s41598-021-94402-2.
Schabrun SM, Jones E, Elgueta Cancino EL, Hodges PW. Targeting chronic recurrent low back pain from the top-down and the bottom-up: a combined transcranial direct current stimulation and peripheral electrical stimulation intervention. Brain Stimul. 2014 May-Jun;7(3):451-9. doi: 10.1016/j.brs.2014.01.058. Epub 2014 Jan 30.
Aasa B, Berglund L, Michaelson P, Aasa U. Individualized low-load motor control exercises and education versus a high-load lifting exercise and education to improve activity, pain intensity, and physical performance in patients with low back pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Feb;45(2):77-85, B1-4. doi: 10.2519/jospt.2015.5021.
Other Identifiers
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MU-CIRB 2022/118.0711
Identifier Type: -
Identifier Source: org_study_id
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