Effects of Yoga Versus Passive Modality on Pain, Disability, Salivary Cortisol Concentrations, Brain- Derived Neurotropic Factor, Heart Rate Variability and Immune Functions Among Patients With Chronic Low Back Pain: A Randomized Controlled Trial

Not Applicable

• Conditions: Low Back Pain
• Interventions: Behavioral: passive modality; Behavioral: Yoga treatment

• Registration Number: NCT02244645
• Lead Sponsor: Chang Bing Show Chwan Memorial Hospital

Brief Summary

This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain.

Detailed Description

Low back pain is a common problem, with 70-80% of adults were bothered in their lives, which influence the work and quality of life. Yoga is one of the most popular complementary and alternative medicine for back pain, and this mind-body intervention has increasingly chosen to effectively treat chronic pain.

This is a parallel-arm randomized controlled trial which will compare the outcomes of participants assigned to the experimental treatment group (yoga, with 36 participants) with those assigned to a passive modality control group for 3 months (12 weeks). Each group will receive regular 60-minutes yoga classes or passive modality twice a week. The investigators confer the difference of pain relief and functional life improvement between passive modality and yoga. The latter is expected to have positive effects on Chronic low back pain. The effects and possible mechanisms of action responsible for passive modality and yoga on salivary cortisol concentrations, inflammatory cytokines and autonomic nervous tone will be also evaluated. The study's primary endpoints are (1) back pain relief, (2) functional life improved, (3) Salivary cortisol concentrations decreased, (4) brain-derived neurotrophic factor improved, (5) heart rate variability improved, and (6) immune function improved significantly among the participants in the experimental group than the control group.

This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain. If the results are positive, clinicians will attain more options for treating patient with chronic low back. Furthermore, the positive results from this study will help focus more future in-depth research on the most promising potential mechanism of action identifies.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patient with idiopathic low back pain of more than 12 weeks.

Exclusion Criteria

• Current pregnancy
• Diagnosis of ankylosing spondylitis, osteoporosis, fibromyalgia, failed back syndrome and other chronic illnesses.
• Inability to participate yoga exercise regularly.
• Accept steroid treatment within 3 months.
• BMI > 30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passive modality control group	passive modality	Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.
Yoga treatment group	Yoga treatment	Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.

Primary Outcome Measures

Name	Time	Method
Back pain relief and functional life improved	Change from baseline in back pain and life quality at 6 months	Back pain relief and functional life improved will assessed by visual analogue scale (VAS) and Roland-Morris disability questionnaire at five different times: (1)baseline data : before intervention, (2)outcome data: 3, 6, 9 and 12 week yoga exercise, right after exercise measure post-test.

Secondary Outcome Measures

Name	Time	Method
Salivary cortisol concentrations decreased	Change from baseline in salivary cortisol at 6 months	Cortisol concentrations will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
Heart rate variability improved	Change from baseline in heart rate variability at 6 months	Heart rate variability will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
Immune function improved	Change from baseline in immune function at 6 months	Immune function will be assessed by blood analysis including lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10), lipid prolife and C-reactive protein at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
Brain-derived neurotrophic factor improved	Change from baseline in brain-derived neurotrophic factor at 6 months	Brain-derived neurotrophic factor will be assessed by blood analysis at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.

Trial Locations

Locations (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital; 🇨🇳 Changhua County, Taiwan