- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410208
Effect of PRP With Physiotherapy on Shoulder Impingement
The Effect of Combined PRP and Ideal Physiotherapy Program on Pain and Functionality in Shoulder Impingement Syndrome: A Randomized Controlled Trial
Background Shoulder impingement syndrome is the most common disorder of the shoulder. Study results on the effectiveness of treatment options are inconclusive and limited. Therefore, more evidence is needed for long-term results Objective To investigate the effectiveness of the ideal physiotherapy protocol (IPRP-PT) applied after platelet-rich plasma (PRP) injection on pain and functionality in patients with shoulder impingement syndrome, and to propose an alternative treatment protocol.
Methods The study was performed in 54 patients with shoulder impingement syndrome who were injected with PRP. Patients were randomly divided into two equal groups. For 21 days, the study group received IPRP-PT study protocol, conventional physiotherapy and home exercise programme, while the control group received only conventional physiotherapy programme. Normal range of motion, muscle strength and posture were assessed. In addition, short form Mc-gill (SF-MPQ), Visual Analogue Scale (VAS), Constant Murley Shoulder Score, Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA), were used.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Merkez
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Istanbul, Merkez, Turkey (Türkiye), 08100
- İstinye Üniversitesi
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age between 30-65 years
- Diagnosis of stage I or II shoulder impingement syndrome
- Received one dose of PRP injection
- Referred for and seeking physical therapy
- Voluntary participation
- Ability to cooperate with the study procedures
Exclusion Criteria
- Previous surgical treatment for shoulder impingement syndrome
- Presence of other orthopedic conditions (e.g., shoulder fractures)
- Presence of neuromuscular disease
- Presence of a pacemaker
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
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All patients included in the study were educated about the correct posture in daily life, sleeping position, and the things to be followed to improve the quality of life. In addition to 2 cc anticoagulant citrate dextrose withdrawn syringe, 20 cc of blood was taken by the nurse from the patients diagnosed with shoulder impingement syndrome. After the blood was transferred to a special PRP kit and centrifuged at 4000 rpm for 8-9 minutes, the platelet-rich plasma portion remaining at the top of the kit was taken into the syringe and applied to the 1/3 posterolateral 1/3 of the glenohumeral joint by the physician. After PRP injections, evaluations of the study and control groups were performed before and after 21 days of treatment. The study group received IPRP-PT study protocol, conventional physiotherapy and home exercises, while the control group received only conventional physiotherapy and home programme.
It was applied once a day for 21 days to 54 patients included in the study.
Ultrasound; Enraf Nonius Sonopuls692V® device was applied around the glenohumeral joint with an average treatment dose of 3 MHz, N 1.5 w/cm² and 8 minutes.
Transcutaneous Electrical Nerve Stimulation (TENS); Enraf Nonius Sonopuls 692V® device was applied to the glenohumeral joint with a frequency between 60-120 Hz and a transition time of 50-100 µsec for 20 min.
Hot Pack; It was applied to the glenohumeral joint for 20 minutes (Kuhn, 2009; Kul and Ugur, 2019; Walsh, Howe, Johnson, and Sluka, 2009).
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Experimental: Study group
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All patients included in the study were educated about the correct posture in daily life, sleeping position, and the things to be followed to improve the quality of life. In addition to 2 cc anticoagulant citrate dextrose withdrawn syringe, 20 cc of blood was taken by the nurse from the patients diagnosed with shoulder impingement syndrome. After the blood was transferred to a special PRP kit and centrifuged at 4000 rpm for 8-9 minutes, the platelet-rich plasma portion remaining at the top of the kit was taken into the syringe and applied to the 1/3 posterolateral 1/3 of the glenohumeral joint by the physician. After PRP injections, evaluations of the study and control groups were performed before and after 21 days of treatment. The study group received IPRP-PT study protocol, conventional physiotherapy and home exercises, while the control group received only conventional physiotherapy and home programme.
It was applied once a day for 21 days to 54 patients included in the study.
Ultrasound; Enraf Nonius Sonopuls692V® device was applied around the glenohumeral joint with an average treatment dose of 3 MHz, N 1.5 w/cm² and 8 minutes.
Transcutaneous Electrical Nerve Stimulation (TENS); Enraf Nonius Sonopuls 692V® device was applied to the glenohumeral joint with a frequency between 60-120 Hz and a transition time of 50-100 µsec for 20 min.
Hot Pack; It was applied to the glenohumeral joint for 20 minutes (Kuhn, 2009; Kul and Ugur, 2019; Walsh, Howe, Johnson, and Sluka, 2009).
IPRP-PT study protocol was applied in addition to conventional physiotherapy for 21 days in 27 patients who underwent PRP injection in our study group.
The exercises were performed once a day with a physiotherapist and twice a day at home.
The exercises performed were as follows; posterior capsule stretching; wand exercise; scapulatoracic (st), acromioclavicular (ac) and sternoclavicular (sc) joint mobilisation; GH joint posterior, anterior, inferior sliding; GH joint distraction; deep friction massage of the tendon of the supraspinatus muscle; kinesiological taping; isometric and isotonic strengthening exercises; proprioceptive neuromuscular facilitation exercises (pnf); closed kinetic ring and proprioception exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posture Assessment
Time Frame: Baseline and Day 21
|
Corbin posture scale was used.
Postural scores obtained by looking laterally and posteriorly were summed and evaluated as (0-2: excellent, 3-4: very good, 5-7: good, 8-11: fair, 12≥ poor).
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Baseline and Day 21
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Range of Motion (ROM) Evaluation
Time Frame: Baseline and Day 21
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Normal joint movements were assessed using a universal goniometer.
Passive and active shoulder joint flexion, extension, abduction, internal rotation, and external rotation were evaluated.
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Baseline and Day 21
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Manual Muscle Test
Time Frame: Baseline and Day 21
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During the manual muscle test, the patient was positioned appropriately for the muscle being evaluated.
They were asked to actively perform the movement.
The force generated by the muscle was evaluated by applying manual resistance.
Muscle strength of the shoulder flexors, extensors, abductors, internal rotators, and external rotators was rated on a scale of 0-5 (no contraction 0, very weak 1, weak 2, moderate 3, good 4, and normal 5.
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Baseline and Day 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time Frame: Baseline and Day 21
|
DASH consists of 3 parts.
In all questions, the person marks the appropriate answer in the 5-point Likert system.
At the end of the questionnaire, the sum of the marked items is divided by the number of marked items, subtracted by one, then multiplied by 25 and the DASH total score is found.
According to the result of the questionnaire, a score between 0-100 is obtained from each section (0: no disability, 100: maximum disability).
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Baseline and Day 21
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Constant Murley Shoulder Score (CMS)
Time Frame: Baseline and Day 21
|
It is a functional test used to evaluate ROM, muscle strength and functional level of the shoulder joint.
The total constant score is classified as best (90-100), good (80-90), moderate (70-79) and poor (<70).
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Baseline and Day 21
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Pain Assessment
Time Frame: Baseline and Day 21
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Short-form Mc-Gill Pain Questionnaire (SF-MPQ) and Visual Analogue Scale (VAS).
The SF-MPQ assesses the sensory, emotional and intensity of pain.
A total of 15 determinant pain descriptions are included.
Three pain scores (sensory, emotional and total pain rate) are obtained .
VAS In order to evaluate the pain of the patient subjectively, the patient was asked to mark the shoulder pain intensity on the pain scale evaluated over 10 digits.
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Baseline and Day 21
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Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
Time Frame: Baseline and Day 21
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FIT-HaNSA is a standard three-task test battery that assesses functional endurance involving repetitive lifting and overhead activities in the upper extremity.
The tests simulate lifting and sustained shoulder movements performed at a controlled rate (60 beats/min).
In the first two tasks, the participant carries three 1 kg objects one by one between shelves using their affected arm.
The first task represents reaching activities performed at waist level, and the second task represents reaching activities performed at shoulder level.
In the third task, the participant performs screw insertion and removal operations while holding both arms in an overhead position in an eye-level arrangement.
Short rest periods are provided between tasks, and each task lasts a maximum of 300 seconds.
The second at which the patient completes the test is evaluated and recorded.
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Baseline and Day 21
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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
- Decision number 12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Plan Description: Individual participant data will not be shared.
Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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