- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03010878
Yoga and Occupational Therapy to Improve Pain (YoPain)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a randomized control trial completed with two specific aims.
Aim 1: To assess the feasibility of completing a group yoga intervention in conjunction with an ongoing self-management education for people with chronic pain.
Aim 2: To explore the preliminary efficacy of a group yoga intervention in people with chronic pain. The key variables of interest were pain interference, functional performance, balance, strength, mobility, and quality of life (QoL)
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Colorado
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Fort Collins, Colorado, United States, 80524
- UC Health Fort Collins Family Medicine Residency Program Pain Management Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- greater than 18 years of age
- Individual with self-reported pain for over six months
- attending outpatient pain clinic
- ability to attend yoga classes
- ability to complete assessments
- ability to provide informed consent
Exclusion Criteria:
- consistent yoga practice over the past year
- self-reported exercise restrictions
- serious and recent medical procedures or conditions without doctor's note
- high risk pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga Arm
Yoga administered twice a week for 8 weeks.
Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic).
Yoga interventions were administered twice a week at the Pain Clinic.
|
The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community. Yoga was delivered in sitting, standing, and floor postures
The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic.
The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life.
|
Experimental: Wait-list Control Arm
Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic.
|
The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic.
The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory--Short Form
Time Frame: 8 weeks
|
The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale
Time Frame: 8 weeks
|
14 items to assess balance
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15.6017H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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