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OpenTrials
Completed

NCT Number: NCT04388306

Shoulder Functional Performance After Shoulder Surgery

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolu Abant Izzet Baysal University

Bolu, Central, 14000, Turkey (Türkiye)

About this study

Design: observational Cross-sectional study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Shoulder Functionality-Modified Constant Murley Score, Scapular Endurance-Scapular Muscle Endurance Test, Strength-Total Upper Extremity Muscle Strength

Primary outcomes

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

    Time frame: 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 outcomes

  1. Modified Constant Murley Score

    Time frame: 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

    Time frame: Three months

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

  3. Total Upper Extremity Muscle Strength

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 14, 2020
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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