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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

C

Chang Bing Show Chwan Memorial Hospital

Status

Unknown

Conditions

Low Back Pain

Treatments

Behavioral: passive modality
Behavioral: Yoga treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02244645
1010803

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Shu-Hui Yeh, PhD

Data sourced from clinicaltrials.gov

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