CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Group A +1 moreother
Likely dose
Not stated in record
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Search/NCT05248061
NCT05248061N/ACompleted

Comparison of the Effects of Platelet-Rich Plasma Supplementary Exercise and Exercise Only on Pain, Muscle Strength, Functionality, and Quality of Life in Subacromial Impingement Syndrome: A Randomized Controlled Study

University of Beykent·interventional·Posted Feb 21, 2022·Updated Mar 1, 2023

In Brief

A clinical study evaluating Group A and Group B for Subacromial Impingement Syndrome. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Aim: The aim of this study is to compare the effects of platelet-rich plasma application with additional exercise and only exercise application on pain, muscle strength, functionality and quality of life in subacromial impingement syndrome. Material and Method: 56 patients who applied to the clinic with the complaint of shoulder pain and were diagnosed with Subacromial impingement syndrome between February 2022 and February 2023 will be included in the study. After giving the necessary verbal and written information about the study, the patients with informed consent will be randomized and divided into 2 groups of 28 people. The cases will be randomly divided into groups and their treatment will be done by the same researchers. Evaluation will be carried out by another investigator blinded to which group the participants belong to before and after the treatment. After the initial evaluations are completed, the 1st group will be given a home exercise program that they will apply every day for 8 weeks, and the 2nd group will be given 2 doses of PRP with an interval of 2 weeks in addition to the same exercise program. Initial evaluations of the patients will be made before the treatment and will be re-evaluated at the end of the 6th month. Personal information with the Sociodemographic Data Form prepared by us; pain severity by Visual Analogue Scale (VAS); shoulder functionality will be evaluated with the Constant Murley Score, joint range of motion with the Universal Goniometer, muscle strength with the "Hand-held" dynamometer, and quality of life with the SF-36. Statistical Analysis: SPSS (Statistical Package for Social Sciences) (SPSS 21.0) statistical program will be used in the statistical analysis of the data. Mann Whitney-U Test will be used to determine the difference between the efficacy of treatments. P \< 0.05 will be considered statistically significant in all analyses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 21, 2022
Enrollment StartFeb 1, 2022
Primary CompletionFeb 1, 2023
Study CompletionFeb 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 4.4 years ago

Interventions

Group Aother

Wand exercises; It will be applied to increase the normal range of motion of the joint. Exercises will be performed in the directions of shoulder flexion, abduction, external and internal rotation. Objects such as a round stick, walking stick and towel can be used to assist patients during exercise. \- \*Pendulum (Codman) Exercises: These exercises will be applied in 90° flexion of the waist, with the healthy hand resting on a solid place, and turning the arm back and forth, to the sides, clockwise and counterclockwise with circular movements. \*Capsule stretching: Auto stretching (by the patient) will be applied to the posterior region of the shoulder (capsule), pectoralis minor and upper trapezius muscles. \*Isometric shoulder exercises Isometric exercises will be given in the directions of shoulder extension, abduction, external rotation and internal rotation.

Group Bother

The same exercises as in Group 1 will be suitable for the participants. * PRP will be applied in the first session and 2 weeks later. Exercises will be started 2 days after PRP application. * Up to 10 cc of blood will be taken from the PRP group patients by the nurse. 25 mL of venous blood will be collected from each patient at a time, using a syringe containing 2.5 mL of the anticoagulant citrate dextrose solution. After the blood taken is transferred to the special PRP kit and centrifuged for 8 minutes at 3000 rpm, in addition to the 5-6 cc platelet-rich plasma remaining in the upper part of the kit, the entire buffy coat is injected into the syringe from the region compatible with the posterior arthroscopy portal (inferior to the acromion posterolateral bone prominence) by the physician. next, from the end point of the posterior fibers of the deltoid muscle, targeting the subacromial space) will be applied. No buffering or activating agents will be used for PRP.