Comparison of Platelet-Rich Plasma and Additional Exercise and Exercise Only in Subacromial Impingement Syndrome

NCT05248061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

  • Subacromial Impingement Syndrome

Interventions

OTHER

Group A

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.

OTHER

Group B

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.

Sponsors & Collaborators

  • University of Beykent

    lead OTHER

Principal Investigators

  • Yasemin ŞAHBAZ · University Beykent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-02-01
Completion
2023-02-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05248061 on ClinicalTrials.gov