Yoga and Occupational Therapy to Improve Pain (YoPain)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yoga
Self-management
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring yoga, chronic pain, occupational therapy, self-management
Eligibility Criteria
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
Sites / Locations
- UC Health Fort Collins Family Medicine Residency Program Pain Management Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Yoga Arm
Wait-list Control Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Brief Pain Inventory--Short Form
The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain.
Secondary Outcome Measures
Berg Balance Scale
14 items to assess balance
Full Information
NCT ID
NCT03010878
First Posted
December 29, 2016
Last Updated
January 3, 2017
Sponsor
Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT03010878
Brief Title
Yoga and Occupational Therapy to Improve Pain
Acronym
YoPain
Official Title
Yoga and Occupational Therapy to Improve Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a randomized control trial of a yoga and self-management intervention for individuals with chronic pain. Participants were assigned to either a wait-list control group (self-management only), or a yoga intervention (self-management and yoga). Self-management education session occurred monthly within the community. Group yoga intervention was delivered two times a week with a specifically designed program that was progressively more difficult. Assessments were then administered pre and post intervention, and a semi-structured interview was completed following the intervention. Quantitative and qualitative data were then compared between groups.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
yoga, chronic pain, occupational therapy, self-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list Control Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Self-management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory--Short Form
Description
The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
14 items to assess balance
Time Frame
8 weeks
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene Schmid, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Health Fort Collins Family Medicine Residency Program Pain Management Clinic
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29526474
Citation
Schmid AA, Atler KE, Malcolm MP, Grimm LA, Klinedinst TC, Marchant DR, Marchant TP, Portz JD. Yoga improves quality of life and fall risk-factors in a sample of people with chronic pain and Type 2 Diabetes. Complement Ther Clin Pract. 2018 May;31:369-373. doi: 10.1016/j.ctcp.2018.01.003. Epub 2018 Feb 15.
Results Reference
derived
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Yoga and Occupational Therapy to Improve Pain
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