TY - JOUR
T1 - Comparison of yoga and dynamic neuromuscular stabilization exercise in chronic low back pain on magnetic resonance imaging of lumbar multifidus- protocol for a randomized controlled trial
AU - Venkatesan, Prem
AU - K, Soundararajan
AU - Kishen, Thomas J.
AU - Janardhan, Seema
AU - Kumar CR, Sathish
N1 - Funding Information:
This study trial is funded by the DST-funded project (Reference No- DST/SATYAM/2018/156) under Science and Technology for Yoga and Meditation (SATYAM) .
Funding Information:
The authors express their gratitude to the Government of India Ministry of Science and Technology, Department of Science and Technology (DST) under Science and Technology for Yoga and Meditation (SATYAM) and Manipal College of Health Professionals (MCHP) Bangalore Campus- Manipal Academy of Higher Education (MAHE), Manipal Hospital Bangalore (MHB) which supported and facilitated this study.
Funding Information:
When a participant exhibits any serious physical or mental health symptoms as noted by the study therapist, a participant or attendee, the study coordinator, or anyone else, the participant safety protocol will be triggered. The participant is contacted and assessed by a study clinician before being cleared for safety or referred for additional care in all cases of Safety protocol beginning. All adverse events are recorded, reported, and categorized as per funding agency, IEC, and other regulatory requirements. The study team reviews the adverse event reports regularly.This study trial is funded by the DST-funded project (Reference No- DST/SATYAM/2018/156) under Science and Technology for Yoga and Meditation (SATYAM).The authors express their gratitude to the Government of India Ministry of Science and Technology, Department of Science and Technology (DST) under Science and Technology for Yoga and Meditation (SATYAM) and Manipal College of Health Professionals (MCHP) Bangalore Campus- Manipal Academy of Higher Education (MAHE), Manipal Hospital Bangalore (MHB) which supported and facilitated this study.
Publisher Copyright:
© 2022
PY - 2022/8
Y1 - 2022/8
N2 - Background: Degeneration of Lumbar muscle in chronic low back pain (CLBP) is characterized by an increase in fat infiltration of paraspinal muscle, decrease in the cross-sectional area (CSA) of lumbar multifidus muscle (LMM) and increased thickness of Thoracolumbar fascia (TLF) by 25%. The study objective is to compare the effects of yoga and dynamic neuromuscular stabilization (DNS) exercise on CSA, fat infiltration of LMM with magnetic resonance imaging (MRI), and TLF thickness using musculoskeletal ultrasound imaging (MSK-USI) in CLBP. Methods: One hundred and forty-four participants with CLBP, which persisted longer than three months, will be recruited for this trial. Both group interventions focused on LMM. The experimental group will receive structured yoga sessions, and the Control Group will receive exercise based on DNS. In each group, exercises will be performed for 3–5 days/week and progressed for 12 weeks. Baseline data will be collected, followed by the recording of primary outcome measure (MRI) and secondary outcome measures (MSK-USI, Oswestry disability index, visual analogue score, optimism, self-efficacy, mood, physical activity, fear of movement, pain catastrophizing, and coping) at baseline and the end of 12th weeks. The normality of data will be verified. Based on the data distribution, within-group analysis and between-group analysis will be performed. Discussion: This will be the first RCT to compare the effect of yoga and DNS exercise among chronic low back pain participants. This will provide evidence of these interventions' impact on CSA, fat infiltration of LMM, and thickness of TLF in CLBP. Registration number: CTRI/2021/08/035984 (This trial was registered prospectively).
AB - Background: Degeneration of Lumbar muscle in chronic low back pain (CLBP) is characterized by an increase in fat infiltration of paraspinal muscle, decrease in the cross-sectional area (CSA) of lumbar multifidus muscle (LMM) and increased thickness of Thoracolumbar fascia (TLF) by 25%. The study objective is to compare the effects of yoga and dynamic neuromuscular stabilization (DNS) exercise on CSA, fat infiltration of LMM with magnetic resonance imaging (MRI), and TLF thickness using musculoskeletal ultrasound imaging (MSK-USI) in CLBP. Methods: One hundred and forty-four participants with CLBP, which persisted longer than three months, will be recruited for this trial. Both group interventions focused on LMM. The experimental group will receive structured yoga sessions, and the Control Group will receive exercise based on DNS. In each group, exercises will be performed for 3–5 days/week and progressed for 12 weeks. Baseline data will be collected, followed by the recording of primary outcome measure (MRI) and secondary outcome measures (MSK-USI, Oswestry disability index, visual analogue score, optimism, self-efficacy, mood, physical activity, fear of movement, pain catastrophizing, and coping) at baseline and the end of 12th weeks. The normality of data will be verified. Based on the data distribution, within-group analysis and between-group analysis will be performed. Discussion: This will be the first RCT to compare the effect of yoga and DNS exercise among chronic low back pain participants. This will provide evidence of these interventions' impact on CSA, fat infiltration of LMM, and thickness of TLF in CLBP. Registration number: CTRI/2021/08/035984 (This trial was registered prospectively).
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U2 - 10.1016/j.conctc.2022.100937
DO - 10.1016/j.conctc.2022.100937
M3 - Article
AN - SCOPUS:85132911474
SN - 2451-8654
VL - 28
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100937
ER -