Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
1 other identifier
interventional
151
1 country
1
Brief Summary
The purpose of this study is to determine the effect of relaxation exercises on pain level and pain medication use after arthroscopic rotator cuff shoulder surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2018
CompletedFirst Submitted
Initial submission to the registry
January 28, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedJanuary 30, 2020
January 1, 2020
12 months
January 28, 2020
January 29, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Opioid Consumption
total opioid consumption will be calculated into Morphine Equivalent Units for each patients from the time of surgery to the first 5 days after surgery
From surgery to 5 days after surgery
Post-operative pain
Pain as reported via visual analog scale will be calculated as a continuous variable from surgery through 5 days after surgery
From surgeyr to 5 days after surgery
Study Arms (2)
Relaxation Group
ACTIVE COMPARATORControl group
NO INTERVENTIONInterventions
This group will be asked to watch a video and perform relaxation techniques twice a day following surgery
Eligibility Criteria
You may qualify if:
- Males and nonpregnant females aged 18 years or older
- full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair surgery
You may not qualify if:
- Patients with an irreparable tear, revision shoulder surgery, multiple shoulder surgeries, concomitant severe glenohumeral arthritis, concomitant adhesive capsulitis
- worker's compensation claim
- diagnosed psychological disorder
- history of alcohol or drug abuse
- patients on preoperative narcotic therapy
- patients who already practice relaxation techniques (i.e. mindful meditation, guided imagery, breathing exercises, yoga, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopaedic Institute
Egg Harbor, New Jersey, 08234, United States
Related Publications (1)
Weekes DG, Campbell RE, Wicks ED, Hadley CJ, Chaudhry ZS, Carter AH, Pepe MD, Tucker BS, Freedman KB, Tjoumakaris FP. Do Relaxation Exercises Decrease Pain After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Clin Orthop Relat Res. 2021 May 1;479(5):870-884. doi: 10.1097/CORR.0000000000001723.
PMID: 33835103DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2020
First Posted
January 30, 2020
Study Start
March 17, 2017
Primary Completion
March 14, 2018
Study Completion
September 10, 2018
Last Updated
January 30, 2020
Record last verified: 2020-01