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CompletedNCT04388306Updated May 14, 2020

Shoulder Functional Performance After Shoulder Surgery

An observational study in Rotator Cuff Tears, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-14.

Sponsored by Abant Izzet Baysal University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
64
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Design: observational Cross-sectional study.

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Conditions studied

  • Rotator Cuff Tears

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03

In context

Rotator Cuff Injuries

734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.

This study's enrollment of 64 is close to the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
64 participants (actual)
Target follow-up
4 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherShoulder 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.

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

06

What researchers measure

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.

    Time frame: Three months

Secondary outcomes

  1. 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.

    Time frame: Three months

  2. Scapular Muscle Endurance Test

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

    Time frame: Three months

  3. 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.

    Time frame: Three months

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Study locations

1 site
  • Bolu Abant Izzet Baysal University
    Bolu, Central 14000, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04388306
Lead sponsor
Abant Izzet Baysal University
Responsible party
Beyza Yazgan Dagli (Research Assistant, Abant Izzet Baysal University) — Principal investigator
First posted
May 14, 2020
Start date
Jun 12, 2018
Primary completion
Dec 25, 2018
Completion
Jan 16, 2019
Last update
May 14, 2020

Study contacts

Beyza YAZGAN DAĞLI
principal investigator · Abant Izzet Baysal University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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