Clinical trial NCT02244645: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain, physical therapy, yoga.
Lead sponsor: Chang Bing Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Back pain relief and functional life improved
timeFrame: Change from baseline in back pain and life quality at 6 months
Secondary outcomes:
measure: Salivary cortisol concentrations decreased
timeFrame: Change from baseline in salivary cortisol at 6 months
measure: Heart rate variability improved
timeFrame: Change from baseline in heart rate variability at 6 months
measure: Immune function improved
timeFrame: Change from baseline in immune function at 6 months
measure: Brain-derived neurotrophic factor improved
timeFrame: Change from baseline in brain-derived neurotrophic factor at 6 months
Other outcomes:
Locations:
city: Changhua County
country: Taiwan
facility: Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Study officials:
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Kuender D. Yang, MD, PhD
role: STUDY_CHAIR
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Shu-Hui Yeh, PhD.
role: STUDY_DIRECTOR
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Kwan-Yu Chan, MD.
role: PRINCIPAL_INVESTIGATOR
References: