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

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ClinicalTrials.gov Identifier: NCT04249089
Recruitment Status : Completed
First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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

Condition or disease Intervention/treatment Phase
Rotator Cuff Injuries Behavioral: Relaxation video and pamplet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
Actual Study Start Date : March 17, 2017
Actual Primary Completion Date : March 14, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.).

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): NCT04249089


Locations
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United States, New Jersey
Rothman Orthopaedic Institute
Egg Harbor Township, New Jersey, United States, 08234
Sponsors and Collaborators
Rothman Institute Orthopaedics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04249089    
Other Study ID Numbers: 2017-TJ
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020

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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
Rotator Cuff Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries