Rehabilitation After Rotator Cuff Repair

Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study

A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injury
• Intervention / Treatment: Other: Early mobilization; Other: Post surgery shoulder lock

Detailed Description

A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västmanland
    • Västerås, Västmanland, Sweden, 721 89
      • Department of Orthopaedic surgery, Physiotherapy

Participation Criteria

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:

• planned shoulder surgery, rotator cuff repair

Exclusion Criteria:

• not swedish speaking
• reoperation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early mobilization; Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only.	Other: Early mobilization; Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.; Other Names: Collar´n cuff 4 weeks post surgery and early mobilization
Other: Post surgery shoulder lock; Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks	Other: Post surgery shoulder lock; Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.; Other Names: Shoulder lock three weeks post surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder function	Shoulder function is assessed by Constant score	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Visual analogue scale	6 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	Quality of life	6 months after surgery
Quality of life shoulder specific	Western Ontario Rotator Cuff Index (WORC)	6 months after surgery
Pain	Visual analogue scale	12 months after surgery
Euro quality of Life 5D	Quality of life	12 months after surgery
Quality of life shoulder specific	Western Ontario Rotator Cuff Index (WORC)	12 months after surgery

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Chair: Ann Christin Johansson, PhD, Center for Clinical Research County Västmanland, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pain; rehabilitation; quality of life; function; rotator cuff injury; shoulder surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: LTV-426521; ACJCKFVästerås (Other Identifier: UppsalaU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO