Clinical trial NCT01739140: Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA)
Official title: Yoga for Chronic Low Back Pain and Its Mechanism of Action (YoMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Bowes Fund for Innovative Research
First posted: 2012-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to better understand how a yoga intervention helps improve symptoms in people with chronic low back pain. This study will be a 12-week intervention of about 24 participants with chronic low back pain where all individuals will receive weekly yoga classes and instructions for home practice. The purpose of this study is to collect feasibility data and to conduct preliminary analyses in preparation for a larger planned NIH study.


Eligibility criteria: Inclusion Criteria:

* Chronic low back pain lasting \> 3 months
* Back pain that is rated at least 3 on a numeric pain rating scale that ranges from 0 to 10 (0-no pain, 10 worst pain imaginable).
* English language fluency

Exclusion Criteria:

* BMI \> 40
* Inability to provide informed consent
* Recent diagnosis of abdominal aneurism
* Recent diagnosis of metastatic cancer
* Recent diagnosis of discitis
* Recent diagnosis of disk disease
* Recent diagnosis of spinal stenosis
* Recent diagnosis of spondylolisthesis
* Recent diagnosis of infectious cause of back pain
* Recent diagnosis of fracture of vertebra
* Recent diagnosis of Fibromyalgia
* Recent diagnosis of rheumatoid arthritis
* Recent diagnosis of ankylosing spondylitis
* Recent diagnosis of paralysis
* Pregnancy
* Prior or planned back surgery
* Blindness or severe vision problems
* Deafness or severe hearing problems
* Bipolar or manic depression and not taking medication
* Major depression
* Psychoses (major)
* a substance abuse condition
* Dementia
* Unable to get up and down from the floor
* Involvement in a lawsuit related to back pain
* Lack of transportation
* Other disabling chronic conditions (e.g., disabling heart or lung disease, diabetic neuropathy, receiving treatment for hepatitis)
* Currently (within the past 3 months) using yoga classes for more than 15 minutes per week
* Inability to be contacted by phone or email
* no computer access
* schedule does not allow for participation in classes/home practice
* planning to move out of town or take a long vacation during the period of the study

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: Baseline to 3 months post-intervention.
Secondary outcomes:
measure: Numeric Rating Scale for Pain
timeFrame: Baseline to 3 months post-intervention.
measure: Pain Medication Usage Survey
timeFrame: Baseline to 3 months post-intervention.
Other outcomes:
measure: Inflammatory pain related cytokines
timeFrame: Baseline to 3 months post-intervention.
measure: Heart rate variability
timeFrame: Baseline to 3 months post-intervention.
measure: International Physical Activity Questionnaire
timeFrame: Baseline to 3 months post-intervention.
measure: Pain Catastrophizing Scale
timeFrame: Baseline to 3 months post-intervention.
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline to 3 months post-intervention.
measure: Multidimensional Assessment of Interoceptive Awareness
timeFrame: Baseline to 3 months post-intervention.
measure: Patient Reported Outcomes Measurement Information System: Pain - Behavior
timeFrame: Baseline to 3 months post-intervention.
measure: Patient Reported Outcomes Measurement Information System: Pain - Interference
timeFrame: Baseline to 3 months post-intervention.
measure: Patient Reported Outcomes Measurement Information System: Emotional Distress - Depression
timeFrame: Baseline to 3 months post-intervention.
measure: Patient Reported Outcomes Measurement Information System: Emotional Distress - Anxiety
timeFrame: Baseline to 3 months post-intervention.
measure: Patient Reported Outcomes Measurement Information System: Physical Function
timeFrame: Baseline to 3 months post-intervention.
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco's Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sarah Corey, PhD
role: PRINCIPAL_INVESTIGATOR
References: