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

September 18, 2014 updated by: Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua County, Taiwan
        • Recruiting
        • Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Passive modality control group
Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.
Behavioral: passive modality
Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.
Experimental: Yoga treatment group
Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.
Behavioral: Yoga treatment
Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back pain relief and functional life improved
Time Frame: 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.
Change from baseline in back pain and life quality at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cortisol concentrations decreased
Time Frame: 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.
Change from baseline in salivary cortisol at 6 months
Heart rate variability improved
Time Frame: 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.
Change from baseline in heart rate variability at 6 months
Immune function improved
Time Frame: 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.
Change from baseline in immune function at 6 months
Brain-derived neurotrophic factor improved
Time Frame: 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.
Change from baseline in brain-derived neurotrophic factor at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Bing Show Chwan Memorial Hospital

Investigators

  • Study Chair: Kuender D. Yang, MD, PhD, Chang Bing Show Chwan Memorial Hospital
  • Study Director: Shu-Hui Yeh, PhD., Chang Bing Show Chwan Memorial Hospital
  • Principal Investigator: Kwan-Yu Chan, MD., Chang Bing Show Chwan Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1010803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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