Shoulder Functional Performance After Shoulder Surgery

NCT04388306 | Completed

• 1 other identifier: AIBU-FTR-BYD-01
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Modified Constant Murley Score

  Three months

• Scapular Muscle Endurance Test

  Three months

• Total Upper Extremity Muscle Strength

  Three months

Study Arms (2)

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)

Control Group

Thirty-two healthy participants

Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)

Interventions

Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA) OTHER

Participants were evaluated with all tests, respectively. To eliminate the fatigue factor, 5 minutes breaks were given after each test.

Also known as: Shoulder Functionality-Modified Constant Murley Score, Scapular Endurance-Scapular Muscle Endurance Test, Strength-Total Upper Extremity Muscle Strength

Control Group; Study Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group consists of participants with undergone arthroscopic RC repair at Bolu Abant İzzet Baysal University, Department of Orthopedics and Traumatology.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Central, 14000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Beyza YAZGAN DAĞLI

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 14, 2020
• Study Start: June 12, 2018
• Primary Completion: December 25, 2018
• Study Completion: January 16, 2019
• Last Updated: May 14, 2020

Record last verified: 2020-05

Locations

TU (1)