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

February 28, 2023 updated by: Yasemin Şahbaz, University of Beykent

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

56 patients who applied to the clinic with the complaint of shoulder pain between February 2022 and February 2023 and were diagnosed with Subacromial impingement syndrome by the investigative orthopedist according to predetermined valid criteria 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. The 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.

Patients who were diagnosed with subacromial impingement syndrome, between the ages of 45 and 65, without a history of shoulder injury other than subacromial impingement in the last 1 year and/or shoulder symptoms requiring treatment, who had not had any previous shoulder surgery and who agreed to participate in the study will be included in the study. Not meeting the inclusion criteria, a history of shoulder fracture, dislocation and/or cervical radiculopathy, presence of frozen shoulder, previous shoulder surgery, local corticosteroid injection/treatment to the shoulder joint in the last 3 months, presence of neuromuscular disease, pregnancy, history of cancer Patients with unstable angina, systemic inflammatory joint disease, conditions where exercise is contraindicated, orthopedic, rheumatic or congenital disease in the affected upper extremity, and communication problems will be excluded from the study.

The number of our volunteers was calculated with the "G power sample size calculator". In order to be able to determine at 80% power and 0.05 significance level, when the values of the first group are taken as 7.3±0.6 and the values of the second group as 6.9±0.5 using the initial and final pain scores according to the visual analag scale at a 95% confidence interval. At least 25 volunteers should be included in each group. Despite the possibility of the participants leaving the study, 3 people will be added to each group and a total of 56 volunteers will be included in the study. Consent will be obtained from the cases with a voluntary information form.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

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

  • Turkey
      • Istanbul, Turkey, 34500
        • Beykent 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with subacromial impingement syndrome
  • Between the ages of 45-65
  • No history of shoulder injury other than subacromial impingement in the last 1 year and/or no shoulder symptoms requiring treatment
  • Patients who have not had any shoulder surgery before and who agreed to participate in the study

Exclusion Criteria:

  • Not meeting the inclusion criteria
  • History of shoulder fracture, dislocation and/or cervical radiculopathy, presence of frozen shoulder, previous shoulder surgery
  • Presence of neuromuscular disease who has received local corticosteroid injection/treatment to the shoulder joint in the last 3 months
  • Pregnancy, history of cancer, unstable angina, systemic inflammatory joint disease, conditions where exercise is contraindicated, presence of orthopedic, rheumatic or congenital disease in the affected upper extremity
  • Patients with communication problems will be excluded from the study.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
home exercise program
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.
Experimental: Group B
PRP+home exercise program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Murley Score
Time Frame: through study completion, an average of 6 months
Omuz fonksiyonelliğini değerlendiren, objektif ve subjektif verilere dayanan bir skorlama sistemidir. Ağrı, günlük yaşam aktiviteleri, hareket ve kuvvet parametrelerinden oluşur. Toplamda 100 puan üzerinden değerlendirilir. Puan artması hastanın kliniğinin iyi olduğunu ifade eder. Türkçe güvenilirlik ve geçerlilik çalışması yapılmıştır (Çelik D. 2016).ty.
through study completion, an average of 6 months
Visual Analog Scale
Time Frame: through study completion, an average of 6 months
Participants are asked to select the point where they feel their pain on a 10-centimeter (cm) horizontal line. 0 - no pain, 10 - unbearable pain. Pain conditions are evaluated separately at night, during activity and at rest.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Universal Goniometry
Time Frame: through study completion, an average of 6 months
Goniometric measurement is a method that is frequently used in the clinical evaluation of ROM. In addition to evaluating the range of motion of the joint, it is also used to determine functional capacity, to decide on the treatment program and to determine the effectiveness of the treatment.
through study completion, an average of 6 months
"Hand-held" dynamometer
Time Frame: through study completion, an average of 6 months
"Hand-held" dynamometers are accepted as a more valid method for measuring muscle strength compared to isokinetic devices due to reasons such as transportation, cost and convenience.
through study completion, an average of 6 months
SF-36
Time Frame: through study completion, an average of 6 months
It was developed by Rand Corporation in 1992 to examine health-related quality of life. This scale consists of 36 questions and 8 sub-dimensions (physical and social functionality, role limitation [physical and emotional], vitality, pain and mental health). In the scale, points between 0 and 100 can be obtained from each sub-dimension. The increase in the scores obtained in the scale indicates that the health-related quality of life increases.
through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

University of Beykent

Investigators

  • Study Director: Yasemin ŞAHBAZ, University Beykent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBeykent-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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