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History of Changes for Study: NCT04249089
Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
Latest version (submitted January 29, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 29, 2020 None (earliest Version on record)
Comparison Format:

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Study NCT04249089
Submitted Date:  January 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2017-TJ
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?
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2020
Overall Status: Completed
Study Start: March 17, 2017
Primary Completion: March 14, 2018 [Actual]
Study Completion: September 10, 2018 [Actual]
First Submitted: January 28, 2020
First Submitted that
Met QC Criteria:
January 29, 2020
First Posted: January 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
January 29, 2020
Last Update Posted: January 30, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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
Detailed Description:
Open or close this module Conditions
Conditions: Rotator Cuff Injuries
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 151 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Relaxation Group Behavioral: Relaxation video and pamplet
This group will be asked to watch a video and perform relaxation techniques twice a day following surgery
No Intervention: Control group
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Opioid Consumption
[ Time Frame: From surgery to 5 days after surgery ]

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
2. Post-operative pain
[ Time Frame: From surgeyr to 5 days after surgery ]

Pain as reported via visual analog scale will be calculated as a continuous variable from surgery through 5 days after surgery
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.).
Open or close this module Contacts/Locations
Locations: United States, New Jersey
Rothman Orthopaedic Institute
Egg Harbor Township, New Jersey, United States, 08234
Open or close this module IPDSharing
Plan to Share IPD:
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Links:
Available IPD/Information:

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