- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04249089
Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
January 29, 2020 updated by: Rothman Institute Orthopaedics
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Egg Harbor Township, New Jersey, United States, 08234
- Rothman Orthopaedic Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group
|
|
ACTIVE_COMPARATOR: Relaxation Group
|
This group will be asked to watch a video and perform relaxation techniques twice a day following surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From surgery to 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
|
From surgeyr to 5 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 17, 2017
Primary Completion (ACTUAL)
March 14, 2018
Study Completion (ACTUAL)
September 10, 2018
Study Registration Dates
First Submitted
January 28, 2020
First Submitted That Met QC Criteria
January 29, 2020
First Posted (ACTUAL)
January 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 30, 2020
Last Update Submitted That Met QC Criteria
January 29, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-TJ
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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