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

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 30, 2020
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE March 17, 2017
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
Official Title  ICMJE Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Injuries
Intervention  ICMJE Behavioral: Relaxation video and pamplet
This group will be asked to watch a video and perform relaxation techniques twice a day following surgery
Study Arms  ICMJE
  • Active Comparator: Relaxation Group
    Intervention: Behavioral: Relaxation video and pamplet
  • No Intervention: Control group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2020)
151
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 10, 2018
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04249089
Other Study ID Numbers  ICMJE 2017-TJ
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP