Instability; Back Clinical Trial
Official title:
The Effect of Combined Neuromuscular Electrical Stimulation and Motor Control Training on Lumbar Multifidus Muscle Activation in Individuals With Impaired Lumbopelvic Control
Verified date | March 2023 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 50 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Physical Therapy, Mahidol University | Salaya | Nakhon Pathom |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | National Taiwan University |
Thailand,
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
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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Completed |
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