Shoulder Functional Performance After Shoulder Surgery

Rotator Cuff Tears Clinical Trial

Official title:

Functional Performance of Shoulder After Arthroscopic Rotator Cuff Repair and Investigation of Performance Related Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388306
• Other study ID #: AIBU-FTR-BYD-01
• Status: Completed
• Start date: June 12, 2018
• Est. completion date: January 16, 2019

Study information

• Verified date: May 2020
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.

Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. In the acute period after arthroscopic RC repair, shoulder joint range of motion (ROM), muscle strength and shoulder functionality are decreased and daily activities are adversely affected. In the long-term, many studies have reported that these symptoms gradually decreaced.

Many studies investigating postoperative treatment of RC rupture have mostly focused on parameters such as postoperative pain, functionality, muscle strength, ROM and quality of life.Evaluation of these clinical parameters is necessary for patient follow-up in the early period. However, it is unclear whether the biomechanical etiologic factors continue that lead to RC rupture in the advanced period after surgery.

Therefore, the objective of this study was functional performance of shoulder after arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.

Description:

Design: observational Cross-sectional study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 16, 2019
• Est. primary completion date: December 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• With the same RC surgical procedure and technique,

• With acromioplasty and/or tenodesis with RC repair,

• Undergoing arthroscopic RC repair from the upper extremity of the dominant side,

• Having completed the 12th week after surgery,

• Performing 90° and above active shoulder elevation movement

Exclusion Criteria:

• Having undergone revision surgery or previous shoulder surgery, a history of fracture of the upper extremity

• Having undergone surgery causing limitation of motion in the spine,

• Having a neurological and/or vestibular and/or rheumatologic disease,

• Participants with diabetes mellitus, hypertension, cardiovascular and chronic respiratory disease that may cause problems during the test

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Other:
• Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
Participants were evaluated with all tests, respectively. To eliminate the fatigue factor, 5 minutes breaks were given after each test.

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University	Bolu	Central

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)	FIT-HaNSA is a test battery consisting of 3 tasks simulating overhead work and lifting activities designed to evaluate the shoulder functional performance.	Three months
Secondary	Modified Constant Murley Score	Shoulder functionality was analyzed by using the MCMS evaluating pain, daily living activities, ROM and strength. Pain was evaluated by visual analog scale and ROM by goniometer. The force in the shoulder abduction position was measured with the Digital analyzer defined by the spring balance technique.	Three months
Secondary	Scapular Muscle Endurance Test	The scapular muscle endurance test evaluate the endurance of the serratus anterior and the trapezium muscles.	Three months
Secondary	Total Upper Extremity Muscle Strength	Total upper extremity muscle strength was evaluated with Jamar hand dynamometer. Grip strength is considered to be a valid value of TUEMS. The test was performed by measuring both sides.	Three months