Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair

February 1, 2023 updated by: Beyza Yazgan Dagli, Abant Izzet Baysal University

Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair: Which Factors Differ From Healthy Individuals?

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Central
      • Bolu, Central, Turkey, 14000
        • Bolu abant Izzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent arthroscopic RM surgery who had undergone the same arthroscopic RM surgical procedure and technique

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RC Repair Group
Participants 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
Assessment
Healthy Group
Participants who had not undergone any shoulder surgery, had no history of shoulder-related pain, discomfort, or trauma in the last year
Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal alignment and mobility assessment
Time Frame: 8 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scapular dyskinesia
Time Frame: 8 months
Performed using the observational scapular dyskinesia test
8 months
Range of Motion
Time Frame: 8 months
Performed using with Goniometer
8 months
Postural stability
Time Frame: 8 months
Performed using with functional reach test
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2018

Primary Completion (ACTUAL)

May 25, 2019

Study Completion (ACTUAL)

January 15, 2020

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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