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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Passive modality control group

Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.

Group Type OTHER

passive modality

Intervention Type BEHAVIORAL

Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.

Yoga treatment group

Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.

Group Type EXPERIMENTAL

Yoga treatment

Intervention Type BEHAVIORAL

Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.

Interventions

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passive modality

Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.

Intervention Type BEHAVIORAL

Yoga treatment

Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No