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

NCT02244645 | Unknown DMC

• 1 other identifier: 1010803
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain, physical therapy, yoga.

Outcome Measures

Primary Outcomes (1)

• Back pain relief and functional life improved

  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 Outcomes (4)

• Salivary cortisol concentrations decreased

  Change from baseline in salivary cortisol at 6 months

• Heart rate variability improved

  Change from baseline in heart rate variability at 6 months

• Immune function improved

  Change from baseline in immune function at 6 months

• Brain-derived neurotrophic factor improved

  Change from baseline in brain-derived neurotrophic factor at 6 months

Study Arms (2)

Passive modality control group

OTHER

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

Behavioral: passive modality

Yoga treatment group

EXPERIMENTAL

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

Behavioral: Yoga treatment

Interventions

passive modality BEHAVIORAL

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

Passive modality control group

Yoga treatment BEHAVIORAL

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

Yoga treatment group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Bing Show Chwan Memorial Hospital: lead

Study Sites (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, Taiwan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kuender D. Yang, MD, PhD

  Chang Bing Show Chwan Memorial Hospital

  STUDY CHAIR

• Shu-Hui Yeh, PhD.

  Chang Bing Show Chwan Memorial Hospital

  STUDY DIRECTOR

• Kwan-Yu Chan, MD.

  Chang Bing Show Chwan Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Hui Yeh, PhD

CONTACT

yehshuhui@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Professor

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 19, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

TW (1)