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

NCT ID: NCT04249089

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-17

Study Completion Date

2018-09-10

Brief Summary

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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

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Conditions

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Rotator Cuff Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Relaxation Group

Group Type ACTIVE_COMPARATOR

Relaxation video and pamplet

Intervention Type BEHAVIORAL

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Relaxation video and pamplet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Egg Harbor, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33835103 (View on PubMed)

Other Identifiers

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2017-TJ

Identifier Type: -

Identifier Source: org_study_id

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