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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05721547
Other study ID # AIBU-FTR-BYD-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2018
Est. completion date January 15, 2020

Study information

Verified date February 2023
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this observational study was to the alterations in spinal alignment in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals.


Description:

Shoulder dysfunctions are thought to be predisposed by poor posture and muscle imbalances. The shoulder functionality could be limited or worsened by a restricted range of motion (ROM) of the spine. Evidence from studies evaluating both people with shoulder pain and asymptomatic participants indicates a relationship between a decreased thoracic kyphosis and an increased shoulder ROM. Therefore, a higher thoracic kyphosis may be linked to a lower ROM in the shoulder. Shoulder dysfunction becomes more common after the age of 40, and the relationship between spinal posture and shoulder dysfunction is crucially needed to be assessed. The aim of this observational study was to the alterations in spinal alignment and mobility in individuals who have undergone RC surgery and revealed the differences compared to healthy individuals. This cross-sectional observational study was conducted with patients who underwent arthroscopic RM surgery and healthy volunteers.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 15, 2020
Est. primary completion date May 25, 2019
Accepts healthy volunteers
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - those who had undergone the same arthroscopic RM surgical procedure and technique - had undergone acromioplasty and/or tenodesis with RM repair - had undergone arthroscopic RM surgery from the upper extremity of the dominant side; - had completed six months following surgery; were able to perform active shoulder elevation movements of 90° or more - were between the ages of 40 and 75 - were volunteers to participate in the study. Exclusion Criteria: - who had undergone previous shoulder surgery or revision surgery, subscapularis tendon repair in addition to RM repair, scoliosis surgery, or any surgeries to limit spine motion, as well as those with a history of upper extremity fractures, diabetes mellitus, hypertension, cardiovascular disease, or chronic respiratory diseases that could limit the test's ability to be accomplished

Study Design


Intervention

Other:
Assessment
Assessment

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 Spinal alignment and mobility assessment The Spinal Mouse (IDIAG M360), novel, a computer-aided electronic measuring tool that noninvasively evaluates spinal range of motion and intersegmental angles, was used to examine spinal posture. The Spinal Mouse device is reliable and valid for the assessment of spine mobility and posture 8 months
Secondary Scapular dyskinesia Performed using the observational scapular dyskinesia test 8 months
Secondary Range of Motion Performed using with Goniometer 8 months
Secondary Postural stability Performed using with functional reach test 8 months
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