Yoga for Persistent Pain Related to Oncology Surgery

Evaluation of the Transitional Pain Service Surgical Oncology Yoga Program for Individuals With Persistent Pain; a Pilot Randomized Controlled Trial

This randomized controlled trial will evaluate a yoga intervention for individuals who experience persistent pain following oncology surgery. The integrated yoga program will involve postures, breathing exercises, and concentration practices. Data will be collected at several time points (pre-, mid-, and post-intervention) for both the intervention and wait-list control conditions. The data will be analysed using linear mixed effects growth models. Results will be written up in manuscript format, published in a peer review journal, and disseminated at scientific research conferences.

Study Overview

• Status: Completed
• Conditions: Persistent Postoperative Pain
• Intervention / Treatment: Behavioral: Yoga Condition

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is a patient at specific pain clinics
2. Has undergone oncology surgery prior to commencing the yoga intervention
3. Is 18 years of age or older
4. Is able to speak and read English
5. Is able to commit to one weekly, one hour yoga classes for eight weeks
6. Is able to provide a note from their physician or kinesiologist indicating that it is safe for them to participate in a gentle physical activity intervention, such as yoga

Exclusion Criteria:

1. Has pre-existing medical contraindications that preclude participation
2. Has cognitive limitations or language comprehension issues that would impact participation
3. Have had a regular yoga practice in the last six months
4. Documented personality disorder
5. Pregnant women
6. Current enrollment in another research trial evaluating a mind-body intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Yoga Condition; Participants randomized to the Yoga Condition will participate in a specialized yoga intervention.	Behavioral: Yoga Condition; Participants randomized to the Yoga Condition will participate in an integrated yoga program consisting of yoga postures, breathing exercises, and concentration/meditation practices.
NO_INTERVENTION: Wait-List Control Condition; Participants randomized to the Wait-List Control Condition will participate in a specialized yoga intervention once the Yoga Condition has completed their assigned intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in scores on the Pain Catastrophizing Scale	at 0, 4 and 8 weeks

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (ACTUAL): March 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 17-5942.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No