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Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?

Primary Purpose

Rotator Cuff Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation video and pamplet
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and nonpregnant females aged 18 years or older
  2. full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair surgery

Exclusion Criteria:

  1. Patients with an irreparable tear, revision shoulder surgery, multiple shoulder surgeries, concomitant severe glenohumeral arthritis, concomitant adhesive capsulitis
  2. worker's compensation claim
  3. diagnosed psychological disorder
  4. history of alcohol or drug abuse
  5. patients on preoperative narcotic therapy
  6. patients who already practice relaxation techniques (i.e. mindful meditation, guided imagery, breathing exercises, yoga, etc.).

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Relaxation Group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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
Post-operative pain
Pain as reported via visual analog scale will be calculated as a continuous variable from surgery through 5 days after surgery

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
January 29, 2020
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04249089
Brief Title
Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
Official Title
Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation Group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Relaxation video and pamplet
Intervention Description
This group will be asked to watch a video and perform relaxation techniques twice a day following surgery
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
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
Time Frame
From surgery to 5 days after surgery
Title
Post-operative pain
Description
Pain as reported via visual analog scale will be calculated as a continuous variable from surgery through 5 days after surgery
Time Frame
From surgeyr to 5 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and nonpregnant females aged 18 years or older full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair surgery Exclusion Criteria: 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.).
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33835103
Citation
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.
Results Reference
derived

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Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?

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