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

Rotator Cuff Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249089
• Other study ID #: 2017-TJ
• Status: Completed
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: January 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: September 10, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Pain, Postoperative
• Rotator Cuff Injuries

Intervention

Behavioral:
• Relaxation video and pamplet
This group will be asked to watch a video and perform relaxation techniques twice a day following surgery

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Egg Harbor Township	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From surgery to 5 days after surgery
Primary	Post-operative pain	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