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Neuromuscular Electrical Stimulation and Motor Control

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ClinicalTrials.gov Identifier: NCT03786627
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
National Taiwan University
Information provided by (Responsible Party):
Peemongkon Wattananon, Mahidol University

Brief Summary:

Phase I, this study aims to:-

  1. Establish intra- and inter-rater reliability and minimal detectable change of ultrasound imaging measurement
  2. Determine appropriate mode and dose for neuromuscular electrical stimulation on lumbar multifidus muscle
  3. Determine feasibility of proposed protocol and physical therapy intervention

Phase II, this study aims to:-

  1. Determine the difference lumbar multifidus muscle activation based on arthrogenic muscle inhibition model between individuals with and without impaired lumbopelvic control
  2. Determine the effect of combined neuromuscular electrical stimulation and motor control training in individual with impaired lumbopelvic control

Condition or disease Intervention/treatment Phase
Instability; Back Other: Combined NMES and motor control Other: Motor control and placebo NMES Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Physical therapist, investigator, and assessor will be blinded to the group assignment. This process will be handled by the research coordinator.
Primary Purpose: Treatment
Official Title: The Effect of Combined Neuromuscular Electrical Stimulation and Motor Control Training on Lumbar Multifidus Muscle Activation in Individuals With Impaired Lumbopelvic Control
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: Combined NMES and motor control
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
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.

Placebo Comparator: Motor control and placebo NMES
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
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.




Primary Outcome Measures :
  1. Muscle thickness of lumbar multifidus muscle at baseline. [ Time Frame: This outcome will be collected at baseline. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle thickness.

  2. Muscle thickness of lumbar multifidus muscle after the first intervention. [ Time Frame: This outcome will be collected at immediately after the first intervention. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle thickness.

  3. Muscle thickness of lumbar multifidus muscle after 8-week intervention. [ Time Frame: This outcome will be collected at immediately after 8-week intervention. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle thickness.

  4. Cross-sectional area of lumbar multifidus muscle at baseline. [ Time Frame: This outcome will be collected at baseline. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle cross-sectional area.

  5. Cross-sectional area of lumbar multifidus muscle after the first intervention. [ Time Frame: This outcome will be collected at immediately after the first intervention. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle cross-sectional area.

  6. Cross-sectional area of lumbar multifidus muscle after 8-week intervention. [ Time Frame: This outcome will be collected at immediately after 8-week intervention. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle cross-sectional area.

  7. Pennation angle of lumbar multifidus muscle at baseline. [ Time Frame: This outcome will be collected at baseline. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle pennation angle.

  8. Pennation angle of lumbar multifidus muscle after the first intervention. [ Time Frame: This outcome will be collected at immediately after the first intervention. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle pennation angle.

  9. Pennation angle of lumbar multifidus muscle after 8-week intervention. [ Time Frame: This outcome will be collected at immediately after 8-week intervention. ]
    The ultrasound imaging device will be used to measure lumbar multifidus muscle pennation angle.


Secondary Outcome Measures :
  1. Lumbar and hip muscle length. [ Time Frame: This outcome will be collected at baseline only. ]
    Muscle length will be measured by goniometer using modified Thomas and Ober's tests.

  2. Abdominal and back muscle strength. [ Time Frame: This outcome will be collected at baseline only. ]
    Muscle strength will be measured by hand-held dynamometer.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The inclusion criteria for individuals without impaired LPC

    1. Between the ages of 20 and 40
    2. No history of LBP that interferes with activities of daily living and/or required treatment
    3. No aberrant movement pattern during active forward bend test
    4. Passive straight leg raising test (SLR) less than 91 degrees
  • The inclusion criteria for individuals with impaired LPC

    1. Between the ages of 20 and 40
    2. A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
    3. Presenting aberrant movement pattern during active forward bend test
    4. Passive straight leg raising test (SLR) greater than 91 degrees

Exclusion Criteria:

  1. History of seizure for either the subject or any family member
  2. Implanted pacemaker
  3. Clinical signs of systemic disease
  4. Definitive neurologic signs including pain, weakness or numbness in the lower extremity
  5. Previous spinal surgery
  6. Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
  7. Any lower extremity condition that would potentially alter trunk movement
  8. Vestibular dysfunction
  9. Extreme psychosocial involvement
  10. Body mass index (BMI) greater than 30 kg/m2
  11. Active treatment of another medical illness that would preclude participation in any aspect of the study
  12. Menstruation or pregnancy (for female subject)
  13. Diagnosed herniated nucleus pulposus (HNP)
  14. Pain medication usage (e.g., NSAID)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786627


Contacts
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Contact: Peemongkon Wattananon, PhD 66-2-441-5450 ext 21803 peemongkon.wat@mahidol.ac.th
Contact: Hsing-Kuo Wang, PhD 88-623-366-8134 hkwang@ntu.edu.tw

Locations
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Thailand
Faculty of Physical Therapy, Mahidol University Recruiting
Salaya, Nakhon Pathom, Thailand, 73170
Contact: Peemongkon Wattananon, PhD    66-2-441-5450 ext 21803    peemongkon.wat@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University
National Taiwan University
Investigators
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Principal Investigator: Peemongkon Wattananon, PhD Faculty of Physical Therapy, Mahidol University

Publications:
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Responsible Party: Peemongkon Wattananon, Principal investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03786627     History of Changes
Other Study ID Numbers: 2018/199.1010
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD of this study will be shared upon official request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The supporting information will be sent upon official request.
Access Criteria: Having an official written request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peemongkon Wattananon, Mahidol University:
Clinical lumbar instability
History of low back pain
Arthrogenic muscle inhibition
Neuromuscular electrical stimulation
Motor control training