Yoga and Occupational Therapy to Improve Pain

Chronic Pain Clinical Trial

— YoPain  

Official title:

Yoga and Occupational Therapy to Improve Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010878
• Other study ID #: 15.6017H
• Status: Completed
• Phase: Phase 1
• First received: December 29, 2016
• Last updated: January 3, 2017
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Yoga
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
• Self-management
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.

Locations

Country	Name	City	State
United States	UC Health Fort Collins Family Medicine Residency Program Pain Management Clinic	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory--Short Form	The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain.	8 weeks	No
Secondary	Berg Balance Scale	14 items to assess balance	8 weeks	No