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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03786627
Other study ID # 2018/199.1010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date December 31, 2022

Study information

Verified date March 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Thailand Faculty of Physical Therapy, Mahidol University Salaya Nakhon Pathom

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University National Taiwan University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. 2016 Jun 17. doi: 10.3233/BMR-160723. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 Lumbar and hip muscle length. Muscle length will be measured by goniometer using modified Thomas and Ober's tests. This outcome will be collected at baseline only.
Secondary Abdominal and back muscle strength. Muscle strength will be measured by hand-held dynamometer. This outcome will be collected at baseline only.
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