Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915588
• Other study ID #: PMR-Shoulder-001
• Status: Completed
• Phase: N/A
• First received: September 15, 2016
• Last updated: September 23, 2016
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2016
• Source: Johannes Kepler University of Linz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• surgery of the rotator cuff after full thickness tear

• informed consent

• understanding german language

Exclusion Criteria:

• previous surgery of the shoulder

• neurological or systemic diseases with impairment of shoulder function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tear

Intervention

Other:
• early isometric loading after rotator cuff surgery

• passive motion after rotator cuff surgery

Locations

Country	Name	City	State
Austria	Kepler University Hospital	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Kepler University of Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Constant Murley Score	Timepoints: Before surgery; 6, 12, 24 weeks after surgery	up to 24 weeks	No
Secondary	Change of DASH Score	Timepoints Before surgery; 6, 12, 24 weeks after surgery	up to 24 weeks	No
Secondary	Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)	Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Range of movement is measured by handheld goniometer	up to 24 weeks	No
Secondary	Change of Pain (max; average; rest)	Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Pain is measured by Visual Analogue Scale (0-100mm)	up to 24 weeks	No
Secondary	Change of Strength (abduction; external Rotation)	Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Measurement of Strength is evaluated using a BTE Simulator II Dynamometer (Peak torque in N).	up to 24 weeks	No