Trial Outcomes & Findings for Yoga and Occupational Therapy to Improve Pain (NCT NCT03010878)

Results Overview

The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain. Minimum 0 - Maximum 10 (higher score is indicated worse severity and interference with everyday life).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-06-06

Participant Flow

Recruitment completed - all completed at a pain clinic

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.
Overall Study STARTED	44	39
Overall Study COMPLETED	28	39
Overall Study NOT COMPLETED	16	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Yoga and Occupational Therapy to Improve Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Yoga Arm n=28 Participants 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. 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.	Wait-list Control Arm n=39 Participants 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. 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.	Total n=67 Participants Total of all reporting groups
Age, Continuous	53.04 years STANDARD_DEVIATION 9.6 • n=5 Participants	49.15 years STANDARD_DEVIATION 10.82 • n=7 Participants	50.78 years STANDARD_DEVIATION 10.43 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	28 Participants n=5 Participants	39 Participants n=7 Participants	67 Participants n=5 Participants
Brief Pain Inventory	7.05 units on a scale STANDARD_DEVIATION 1.22 • n=5 Participants	6.39 units on a scale STANDARD_DEVIATION 1.53 • n=7 Participants	6.72 units on a scale STANDARD_DEVIATION 1.37 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain. Minimum 0 - Maximum 10 (higher score is indicated worse severity and interference with everyday life).

Outcome measures

Outcome measures
Measure	Yoga Arm n=28 Participants 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. 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.	Wait-list Control Arm n=39 Participants 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. 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.
Brief Pain Inventory--Short Form	7.05 units on a scale Standard Deviation 1.22	6.39 units on a scale Standard Deviation 1.53

Adverse Events

Yoga Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Arlene Schmid

Colorado State University

Phone: 9704917562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place