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Yoga for Persistent Pain Related to Oncology Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460028
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Persistent Postoperative Pain Behavioral: Yoga Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Transitional Pain Service Surgical Oncology Yoga Program for Individuals With Persistent Pain; a Pilot Randomized Controlled Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

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.



Primary Outcome Measures :
  1. Change in scores on the Pain Catastrophizing Scale [ Time Frame: at 0, 4 and 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460028


Contacts
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Contact: Investigator (416) 603-5800 ext 3150 kathryn.curtis@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03460028    
Other Study ID Numbers: 17-5942.0
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms