Neuromuscular Electrical Stimulation and Motor Control

NCT03786627 | Completed

• 1 other identifier: 2018/199.1010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I, this study aims to:-

1. 1.Establish intra- and inter-rater reliability and minimal detectable change of ultrasound imaging measurement
2. 2.Determine appropriate mode and dose for neuromuscular electrical stimulation on lumbar multifidus muscle
3. 3.Determine feasibility of proposed protocol and physical therapy intervention
4. 4.Determine the difference lumbar multifidus muscle activation based on arthrogenic muscle inhibition model between individuals with and without impaired lumbopelvic control
5. 5.Determine the effect of combined neuromuscular electrical stimulation and motor control training in individual with impaired lumbopelvic control

Conditions

Instability; Back

Keywords

Clinical lumbar instability; History of low back pain; Arthrogenic muscle inhibition; Neuromuscular electrical stimulation; Motor control training

Outcome Measures

Primary Outcomes (9)

• Muscle thickness of lumbar multifidus muscle at baseline.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle thickness.

  This outcome will be collected at baseline.

• Muscle thickness of lumbar multifidus muscle after the first intervention.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle thickness.

  This outcome will be collected at immediately after the first intervention.

• Muscle thickness of lumbar multifidus muscle after 8-week intervention.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle thickness.

  This outcome will be collected at immediately after 8-week intervention.

• Cross-sectional area of lumbar multifidus muscle at baseline.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle cross-sectional area.

  This outcome will be collected at baseline.

• Cross-sectional area of lumbar multifidus muscle after the first intervention.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle cross-sectional area.

  This outcome will be collected at immediately after the first intervention.

• Cross-sectional area of lumbar multifidus muscle after 8-week intervention.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle cross-sectional area.

  This outcome will be collected at immediately after 8-week intervention.

• Pennation angle of lumbar multifidus muscle at baseline.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle pennation angle.

  This outcome will be collected at baseline.

• Pennation angle of lumbar multifidus muscle after the first intervention.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle pennation angle.

  This outcome will be collected at immediately after the first intervention.

• Pennation angle of lumbar multifidus muscle after 8-week intervention.

  The ultrasound imaging device will be used to measure lumbar multifidus muscle pennation angle.

  This outcome will be collected at immediately after 8-week intervention.

Secondary Outcomes (2)

• Lumbar and hip muscle length.

  This outcome will be collected at baseline only.

• Abdominal and back muscle strength.

  This outcome will be collected at baseline only.

Study Arms (2)

Combined NMES and motor control

EXPERIMENTAL

This group will receive combined 15-minute neuromuscular electrical stimulation and 30-minute motor control training based on movement system impairment concept.

Other: Combined NMES and motor control

Motor control and placebo NMES

PLACEBO COMPARATOR

This group will receive placebo NMES for 15 minutes followed by 30 minutes motor control training based on movement system impairment concept.

Other: Motor control and placebo NMES

Interventions

Combined NMES and motor control OTHER

This group will receive the neuromuscular electrical stimulation using interferential mode (6000 Hz, beat frequency 20-50 Hz, scanning effect) on bilateral lumbar multifidus muscles. 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 stimulation time is 15 minutes. After that, this group will receive 30 minutes motor control training. This motor control training will focus on the control of the lumbar multifidus muscle in various functional tasks. It is believed to restore the motor units in individuals with arthrogenic muscle inhibition. This motor control training will take approximately 30 minutes. This group will receive intervention twice a week for 8 weeks.

Combined NMES and motor control

Motor control and placebo NMES OTHER

This group will the neuromuscular electrical stimulation without turning the electrical current for 15 minutes. After that, this group will receive 30 minutes motor control training. This motor control training will focus on the control of the lumbar multifidus muscle in various functional tasks. This motor control training will take approximately 30 minutes. This group will receive intervention twice a week for 8 weeks.

Motor control and placebo NMES

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 20 and 40
• No history of LBP that interferes with activities of daily living and/or required treatment
• No aberrant movement pattern during active forward bend test
• Passive straight leg raising test (SLR) less than 91 degrees
• Between the ages of 20 and 40
• A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
• Presenting aberrant movement pattern during active forward bend test
• Passive straight leg raising test (SLR) greater than 91 degrees

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)
• Pain medication usage (e.g., NSAID)

Sponsors & Collaborators

• Mahidol University: lead
• National Taiwan University: collaborator

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (6)

• Kiesel KB, Uhl TL, Underwood FB, Rodd DW, Nitz AJ. Measurement of lumbar multifidus muscle contraction with rehabilitative ultrasound imaging. Man Ther. 2007 May;12(2):161-6. doi: 10.1016/j.math.2006.06.011. Epub 2006 Sep 14.

  PMID: 16973400 BACKGROUND

• Teyhen D, Koppenhaver S. Rehabilitative ultrasound imaging. J Physiother. 2011;57(3):196. doi: 10.1016/S1836-9553(11)70044-3.

  PMID: 21843838 BACKGROUND

• Baek SO, Cho HK, Kim SY, Jones R, Cho YW, Ahn SH. Changes in deep lumbar stabilizing muscle thickness by transcutaneous neuromuscular electrical stimulation in patients with low back pain. J Back Musculoskelet Rehabil. 2017;30(1):121-127. doi: 10.3233/BMR-160723.

  PMID: 27341642 BACKGROUND

• Hicks GE, Sions JM, Velasco TO, Manal TJ. Trunk Muscle Training Augmented With Neuromuscular Electrical Stimulation Appears to Improve Function in Older Adults With Chronic Low Back Pain: A Randomized Preliminary Trial. Clin J Pain. 2016 Oct;32(10):898-906. doi: 10.1097/AJP.0000000000000348.

  PMID: 26736024 BACKGROUND

• Sung W PT, PhD, Wong A BS, MS, Pourshogi A PhD, Pourrezaei K PhD, Silfies S PT, PhD. Near infrared spectroscopy confirms recruitment of specific lumbar extensors through neuromuscular electrical stimulation. Physiother Theory Pract. 2020 Apr;36(4):516-523. doi: 10.1080/09593985.2018.1488908. Epub 2018 Jun 28.

  PMID: 29952686 BACKGROUND

• 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.

  PMID: 34285318 DERIVED

Study Officials

• Peemongkon Wattananon, PhD

  Faculty of Physical Therapy, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Physical therapist, investigator, and assessor will be blinded to the group assignment. This process will be handled by the research coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Subjects with impaired lumbopelvic control will be randomly assigned to either combined NMES with motor control training group, or motor control training alone group using randomly generated number in concealed envelopes.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: April 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The supporting information will be sent upon official request.
• Access Criteria: Having an official written request.

Locations

TH (1)