- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05721547
Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair
Alterations in Spinal Alignment and Mobility in Individuals With Arthroscopic Rotator Cuff Repair: Which Factors Differ From Healthy Individuals?
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Central
-
Bolu, Central, Turkey, 14000
- Bolu abant Izzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-BYD-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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