Shoulder Functional Performance After Shoulder Surgery

• Sponsor: Abant Izzet Baysal University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04388306
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 8.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears	Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)

Detailed Description

Design: observational Cross-sectional study.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 64 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Functional Performance of Shoulder After Arthroscopic Rotator Cuff Repair and Investigation of Performance Related Factors
• Actual Study Start Date: Jun 12, 2018
• Actual Primary Completion Date: Dec 25, 2018
• Actual Study Completion Date: Jan 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Study Group Thirty-two participants with undergone arthroscopic Rotator Cuff repair	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.; Other Names: Shoulder Functionality-Modified Constant Murley Score Scapular Endurance-Scapular Muscle Endurance Test Strength-Total Upper Extremity Muscle Strength
Control Group Thirty-two healthy participants	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.; Other Names: Shoulder Functionality-Modified Constant Murley Score Scapular Endurance-Scapular Muscle Endurance Test Strength-Total Upper Extremity Muscle Strength

Outcome Measures

Primary Outcome Measures

1. Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA) [Three months]

   FIT-HaNSA is a test battery consisting of 3 tasks simulating overhead work and lifting activities designed to evaluate the shoulder functional performance.

Secondary Outcome Measures

1. Modified Constant Murley Score [Three months]

   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.

2. Scapular Muscle Endurance Test [Three months]

   The scapular muscle endurance test evaluate the endurance of the serratus anterior and the trapezium muscles.

3. Total Upper Extremity Muscle Strength [Three months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bolu Abant Izzet Baysal University	Bolu	Central	Turkey	14000

Sponsors and Collaborators

• Abant Izzet Baysal University

Investigators

• Principal Investigator: Beyza YAZGAN DAĞLI, Abant Izzet Baysal University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beyza Yazgan Dagli, Research Assistant, Abant Izzet Baysal University
• ClinicalTrials.gov Identifier: NCT04388306
• Other Study ID Numbers: AIBU-FTR-BYD-01
• First Posted: May 14, 2020
• Last Update Posted: May 14, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rotator Cuff Injuries

Study Results

No Results Posted as of May 14, 2020