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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05561452
Other study ID # ROTCUFFPRP2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date June 25, 2023

Study information

Verified date July 2023
Source Afyonkarahisar Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy of single PRP injection compared with placebo and multiple PRP injections on pain, quality of life, shoulder function and muscle strength in the treatment of patients who have tendinopathy and/or partial tear in the rotator cuff.


Description:

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Study Design


Intervention

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Locations

Country Name City State
Turkey Afyonkarahisar Health Sciences University Afyonkarahi?sar

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) Pain intensity will be measured with Visual Analog Scale (VAS) for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. The level of pain at rest, during motion and during the night will be evaluated with the visual analog scale (VAS). Changes from baseline VAS scores will be assessed at 4th and 12th weeks. up to 12th week
Secondary The Shoulder Pain and Disability Index (SPADI) Shoulder Pain and Disability Index (SPADI) is a two-part scale that evaluates pain and function.The first part questions pain, the second part questions disability. In the pain section consisting of 5 items, the pain felt during activities of daily living is measured using a 10-unit VAS, and in the disability section, the difficulty encountered during activities of daily living is measured througout 8-items. The score of both sections and the total score are calculated with a special formula. Changes from baseline SPADI will be assessed at 4th and 12th weeks. up to 12th week
Secondary The 36-item Short Form Health Survey(SF-36) The Short Form 36 (SF-36) is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score is between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Higher scores indicate better quality of life related to health. Changes from baseline SF-36 scores will be assessed at 4th and 12th weeks. up to 12th week
Secondary Range of Motion(ROM) Range of Motion(ROM)of the shoulder will be measured in 5 planes. It includes abduction in the frontal plane, forward flexion, extension, internal rotation and external rotation with the arm at 0° of abduction. Changes from baseline ROM scores will be assessed at 4th and 12th weeks. up to 12th week
Secondary Constant Murley Score (C-MS) The Constant-Murley Shoulder Score (C-M Score) is a clinical and functional assessment scale that evaluates the functional status of a normal, diseased or treated shoulder. Comparisons can be made in pre-treatment and post-treatment follow-up. Evaluated parameters were pain (15 points), activities of daily living (20 points), ROM (40 points), and strength (25 points). Scoring that measures the functionality of the shoulder consists of 100 points in total. C-M score; It is classified as excellent (90-100), good (80-89), moderate (70-79) and poor (<70). Changes from baseline C-M scores will be assessed at 4th and 12th weeks. up to 12th week
Secondary Isokinetic Test Isokinetic contraction is defined as contraction at a constant rate throughout the entire range of motion and at an equal rate at all angles of motion. No matter how hard a person moves the device, they can never exceed the predetermined speed (for example, 90 degrees per second). It is advantageous that the desired muscle or muscle groups can be evaluated in isolation and that the measurements are comparable. The isokinetic strength assessment of the patients during internal and external rotation of the shoulder will be made with an isokinetic device (IsoMed 2000, Isokinetic dynamometer, Germany). Measurements will be made by a physiotherapist with at least 5 years of device experience. Measurements will be made in 10 repetitions to increase reliability. Change from baseline upper extremity muscle strength with isokinetic device will be assessed at 4th and 12th weeks. up to 12th week
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