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CompletedNCT04249089Updated Jan 30, 2020

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

An interventional study of Relaxation video and pamplet in Rotator Cuff Injuries, sponsored by Rothman Institute Orthopaedics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Rothman Institute Orthopaedics · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Mar 2017, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Rotator Cuff Injuries

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03

In context

Rotator Cuff Injuries

734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.

This study's enrollment of 151 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Rothman Institute Orthopaedics is the lead sponsor of 118 studies on the registry; 17 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
151 participants (actual)

Study arms

  • Active comparator
    Relaxation Group

    Behavioral: Relaxation video and pamplet

  • No intervention
    Control group

Interventions

  • BehavioralRelaxation video and pamplet

    This group will be asked to watch a video and perform relaxation techniques twice a day following surgery

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What researchers measure

Primary outcomes

  1. 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

    Time frame: From surgery to 5 days after surgery

  2. Post-operative pain

    Pain as reported via visual analog scale will be calculated as a continuous variable from surgery through 5 days after surgery

    Time frame: From surgeyr to 5 days after surgery

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Study locations

1 site
  • Rothman Orthopaedic Institute
    Egg Harbor Township, New Jersey 08234, United States
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References and documents

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. PubMed 33835103 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04249089
Lead sponsor
Rothman Institute Orthopaedics
Responsible party
Sponsor
First posted
Jan 30, 2020
Start date
Mar 17, 2017
Primary completion
Mar 14, 2018
Completion
Sep 10, 2018
Last update
Jan 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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