Shoulder PainPRPNCT05561452
The Efficacy of PRP Injection in the Treatment of Rotator Cuff Syndrome
A study testing Single PRP Injection and Multiple PRP Injections in people with Shoulder Pain and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Musculoskeletal Diseases, Rotator Cuff Tendinopathy
- What is being tested?
- Single PRP Injection and Multiple PRP Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain for at least 6 weeks in the participants with 18-65 years of age
- Positivity of shoulder impingement tests on examination (Neer test, Hawkins Kennedy test)
- Findings related to rotator cuff tendinopathy and partial tear in the supraspinatus tendon (< 50%) on MRI
Who cannot join
- Pregnancy
- Inflammatory rheumatologic diseases
- History of malignacy
- Having received physical therapy and rehabilitation for the shoulder in the last 3 months
- Local injection therapy to the shoulder in the last 6 months
- History of trauma, surgery or fracture in the aching shoulder region in the last 6 months
Show all 14Show fewer
- Presence of osteoarthritis findings and labral pathologies, adhesive capsulitis, calcific tendinitis and full-thickness total rupture of the rotator cuff tendons on MRI.
- Cervical radiculopathy
- Cervical myofascial pain syndrome
- Presence of cardiac pacemaker
- Bleeding diathesis
- Body implant with electronic or battery system
- Acute infections
- Tuberculosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahi̇sar, 03200
About this study
Official title: The Efficacy of Single PRP Injection Compared With Placebo and Multiple PRP Injections in the Treatment of Rotator Cuff Syndrome: A Randomized Controlled Study
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.
Read the detailed description
The study is a prospective double-blind randomized placebo-controlled trial. The study population is consisted of patients aged 18-65 years, who applied to the Department of Physical Medicine and Rehabilitation, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey and were diagnosed with rotator cuff tendinopathy and/or partial tear in the supraspinatus tendon (< %50) by clinical and MRI examination, and met the inclusion criteria. The patients will be randomized into 3 groups using a closed envelope method; 1) Single PRP injection, 2) Single placebo injection, and 3) Two PRP injections applied 3 weeks apart. All injections will be performed into the subacromial space under ultrasound guidance. The same physical therapy program will be given to all groups and will be performed at least for 20 minutes daily.
The randomization will be done using the closed envelope method by a researcher who will not perform injections nor evaluate the patients, and to provide blindness, the injectors to be used will be covered with non-transparent tapes by the same investigator. The patients, the physician to make the evaluations, and the physician to perform injections will be blinded to the groups. The solution to be injected will be prepared by another researcher who is not blind. PRP injections will be prepared as follows;10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey). The obtained blood will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. The same amount of blood will be taken for the placebo injection group and after the same waiting time 4 ml of 0.9% saline will be injected using the same method.
Ultrasound guided lateral subacromial injection method will be used. For a safer and more efficient injection, all applications will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz linear probe). To obtain an optimal subacromial appearance with shoulder ultrasonography (USG), the patients will sit upright with their arms back, internally rotated, shoulder hyperextended and elbow flexed to 90° and forearm parallel to the floor. USG in-plane technique will be used in the subacromial region to confirm that the needle stays in the correct place as it is advanced.
Shoulder range of motion will be measured. The level of pain at rest, during motion and during the night will be evaluated with the visual analog scale (VAS). Constant Murley scale and Shoulder Pain and Disability Index (SPADI) will be used for functional evaluation. Quality of life will be assessed with Short-Form 36 (SF-36). Upper extremity muscle strength will be measured with the Isomed-2000® isokinetic device.
The participants in single-PRP injection and single-Placebo injection groups will be evaluated before the injection and 4 and 12 weeks later. Those in the two PRP injections group will be evaluated before the first injection, and 4 and 12 weeks after the second injection.
- Being tested
- Single PRP Injection, Multiple PRP Injections, Placebo Injection
- Keywords
- Platelet rich plasma ( PRP), Subacromial injection, Rotator cuff tendinopathy, Rotator Cuff Syndrome
- Medical subject headings
- Shoulder Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single PRP InjectionOther
In single-PRP injection group, 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily.
Multiple PRP InjectionsOther
In multiple-PRP injection group, two PRP injections will be performed with an interval of 3 weeks. 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained is planned to be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily.
Placebo InjectionOther
In placebo-injection group,10 ml of venous blood will be taken and after the same waiting time 4 ml of 0.9% saline will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily.
| Study group | Role | What they receive |
|---|---|---|
| Single PRP Injection + Exercise | Experimental | In single-PRP injection group, 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz, linear probe).
A home exercise program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be taught and the patients be instructed to perform at least for 20 minutes daily. Receives: Other: Single PRP Injection |
| Multiple PRP Injection+ Exercise | Experimental | In multiple-PRP injection group, two PRP injections will be performed with an interval of 3 weeks. 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz, linear probe).
A home exercise program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be taught and the patients be instructed to perform at least for 20 minutes daily. Receives: Other: Multiple PRP Injections |
| Saline Injection + Exercise | Sham comparator | In placebo-injection group,10 ml of venous blood will be taken and after the same waiting time 4 ml of 0.9% saline will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz, linear probe).
A home exercise program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be taught and the patients be instructed to perform at least for 20 minutes daily. Receives: Other: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12th week
Secondary outcomes (5)
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.
Measured: up to 12th week
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.
Measured: up to 12th week
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.
Measured: up to 12th week
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.
Measured: up to 12th week
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.
Measured: up to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Sep 2022
- Primary completion15 Dec 2022
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshan Hasanov, Afyonkarahisar Health Sciences University
- Investigators
- Selma EROGLU, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561452
- Sponsor's protocol ID
- ROTCUFFPRP2022
- Acronym
- PRP
- Status last verified
- Jul 2023
- First submitted
- 27 Sep 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barreto RB, Azevedo AR, Gois MC, Freire MRM, Silva DS, Cardoso JC. Platelet-Rich Plasma and Corticosteroid in the Treatment of Rotator Cuff Impingement Syndrome: Randomized Clinical Trial. Rev Bras Ortop (Sao Paulo). 2019 Dec;54(6):636-643. doi: 10.1016/j.rboe.2018.03.002. Epub 2019 Dec 13.
PubMed 31875061Hurley ET, Hannon CP, Pauzenberger L, Fat DL, Moran CJ, Mullett H. Nonoperative Treatment of Rotator Cuff Disease With Platelet-Rich Plasma: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2019 May;35(5):1584-1591. doi: 10.1016/j.arthro.2018.10.115. Epub 2019 Apr 15.
PubMed 31000394Kim HM, Dahiya N, Teefey SA, Middleton WD, Stobbs G, Steger-May K, Yamaguchi K, Keener JD. Location and initiation of degenerative rotator cuff tears: an analysis of three hundred and sixty shoulders. J Bone Joint Surg Am. 2010 May;92(5):1088-96. doi: 10.2106/JBJS.I.00686.
PubMed 20439653Ozyalvac ON, Tuzuner T, Gurpinar T, Obut A, Acar B, Akman YE. Radiological and functional outcomes of ultrasound-guided PRP injections in intrasubstance meniscal degenerations. J Orthop Surg (Hong Kong). 2019 May-Aug;27(2):2309499019852779. doi: 10.1177/2309499019852779.
PubMed 31204581Vilchez-Cavazos F, Millan-Alanis JM, Blazquez-Saldana J, Alvarez-Villalobos N, Pena-Martinez VM, Acosta-Olivo CA, Simental-Mendia M. Comparison of the Clinical Effectiveness of Single Versus Multiple Injections of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2019 Dec 16;7(12):2325967119887116. doi: 10.1177/2325967119887116. eCollection 2019 Dec.
PubMed 31897409Walsh MR, Nelson BJ, Braman JP, Yonke B, Obermeier M, Raja A, Reams M. Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up. J Shoulder Elbow Surg. 2018 Sep;27(9):1553-1563. doi: 10.1016/j.jse.2018.05.003. Epub 2018 Jul 9.
PubMed 29996980Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26.
PubMed 23893418
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Single PRP Injection Compared With Placebo and Multiple PRP Injections in the Treatment of Rotator Cuff Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05561452
- Acronym / sponsor ID
- PRP / ROTCUFFPRP2022
- Keywords
- Platelet rich plasma ( PRP), Subacromial injection, Rotator cuff tendinopathy, Rotator Cuff Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a prospective double-blind randomized placebo-controlled trial. The study population is consisted of patients aged 18-65 years, who applied to the Department of Physical Medicine and Rehabilitation, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey and were diagnosed with rotator cuff tendinopathy and/or partial tear in the supraspinatus tendon (< %50) by clinical and MRI examination, and met the inclusion criteria. The patients will be randomized into 3 groups using a closed envelope method; 1) Single PRP injection, 2) Single placebo injection, and 3) Two PRP injections applied 3 weeks apart. All injections will be performed into the subacromial space under ultrasound guidance. The same physical therapy program will be given to all groups and will be performed at least for 20 minutes daily.
The randomization will be done using the closed envelope method by a researcher who will not perform injections nor evaluate the patients, and to provide blindness, the injectors to be used will be covered with non-transparent tapes by the same investigator. The patients, the physician to make the evaluations, and the physician to perform injections will be blinded to the groups. The solution to be injected will be prepared by another researcher who is not blind. PRP injections will be prepared as follows;10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey). The obtained blood will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. The same amount of blood will be taken for the placebo injection group and after the same waiting time 4 ml of 0.9% saline will be injected using the same method.
Ultrasound guided lateral subacromial injection method will be used. For a safer and more efficient injection, all applications will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz linear probe). To obtain an optimal subacromial appearance with shoulder ultrasonography (USG), the patients will sit upright with their arms back, internally rotated, shoulder hyperextended and elbow flexed to 90° and forearm parallel to the floor. USG in-plane technique will be used in the subacromial region to confirm that the needle stays in the correct place as it is advanced.
Shoulder range of motion will be measured. The level of pain at rest, during motion and during the night will be evaluated with the visual analog scale (VAS). Constant Murley scale and Shoulder Pain and Disability Index (SPADI) will be used for functional evaluation. Quality of life will be assessed with Short-Form 36 (SF-36). Upper extremity muscle strength will be measured with the Isomed-2000® isokinetic device.
The participants in single-PRP injection and single-Placebo injection groups will be evaluated before the injection and 4 and 12 weeks later. Those in the two PRP injections group will be evaluated before the first injection, and 4 and 12 weeks after the second injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single PRP Injection + Exercise | Experimental | Other: Single PRP InjectionIn single-PRP injection group, 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz, linear probe). A home exercise program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be taught and the patients be instructed to perform at least for 20 minutes daily. |
| Multiple PRP Injection+ Exercise | Experimental | Other: Multiple PRP InjectionsIn multiple-PRP injection group, two PRP injections will be performed with an interval of 3 weeks. 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz, linear probe). A home exercise program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be taught and the patients be instructed to perform at least for 20 minutes daily. |
| Saline Injection + Exercise | Sham comparator | Other: Placebo InjectionIn placebo-injection group,10 ml of venous blood will be taken and after the same waiting time 4 ml of 0.9% saline will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote® My Lab 70 XVision 6-18 Mhz, linear probe). A home exercise program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be taught and the patients be instructed to perform at least for 20 minutes daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Shoulder pain for at least 6 weeks in the participants with 18-65 years of age
- Positivity of shoulder impingement tests on examination (Neer test, Hawkins Kennedy test)
- Findings related to rotator cuff tendinopathy and partial tear in the supraspinatus tendon (< 50%) on MRI
Key exclusion criteria (14 listed)
- Pregnancy
- Inflammatory rheumatologic diseases
- History of malignacy
- Having received physical therapy and rehabilitation for the shoulder in the last 3 months
- Local injection therapy to the shoulder in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single PRP InjectionIn single-PRP injection group, 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe). A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily. | Other | Single PRP Injection + Exercise |
| Multiple PRP InjectionsIn multiple-PRP injection group, two PRP injections will be performed with an interval of 3 weeks. 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged at 3850 rpm for 8 minutes. Approximately 4 ml of the PRP obtained is planned to be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe). A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily. | Other | Multiple PRP Injection+ Exercise |
| Placebo InjectionIn placebo-injection group,10 ml of venous blood will be taken and after the same waiting time 4 ml of 0.9% saline will be injected into the subacromial space using the lateral subacromial injection method under ultrasound guidance. All injections will be performed in the sagittal axis with the long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe). A physical therapy program including Codman pendulum exercises, shoulder range of motion, stretching and strengthening exercises will be given and be performed at least for 20 minutes daily. | Other | Saline Injection + Exercise |
Primary outcome
Visual Analog Scale (VAS)
Time frame: up to 12th week
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.
5 secondary outcomes
The Shoulder Pain and Disability Index (SPADI)
Time frame: up to 12th week
The 36-item Short Form Health Survey（SF-36）
Time frame: up to 12th week
Range of Motion（ROM）
Time frame: up to 12th week
Constant Murley Score (C-MS)
Time frame: up to 12th week
Isokinetic Test
Time frame: up to 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 31875061Barreto RB, Azevedo AR, Gois MC, Freire MRM, Silva DS, Cardoso JC. Platelet-Rich Plasma and Corticosteroid in the Treatment of Rotator Cuff Impingement Syndrome: Randomized Clinical Trial. Rev Bras Ortop (Sao Paulo). 2019 Dec;54(6):636-643. doi: 10.1016/j.rboe.2018.03.002. Epub 2019 Dec 13.
- Background: PubMed 31000394Hurley ET, Hannon CP, Pauzenberger L, Fat DL, Moran CJ, Mullett H. Nonoperative Treatment of Rotator Cuff Disease With Platelet-Rich Plasma: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2019 May;35(5):1584-1591. doi: 10.1016/j.arthro.2018.10.115. Epub 2019 Apr 15.
- Background: PubMed 20439653Kim HM, Dahiya N, Teefey SA, Middleton WD, Stobbs G, Steger-May K, Yamaguchi K, Keener JD. Location and initiation of degenerative rotator cuff tears: an analysis of three hundred and sixty shoulders. J Bone Joint Surg Am. 2010 May;92(5):1088-96. doi: 10.2106/JBJS.I.00686.
- Background: PubMed 31204581Ozyalvac ON, Tuzuner T, Gurpinar T, Obut A, Acar B, Akman YE. Radiological and functional outcomes of ultrasound-guided PRP injections in intrasubstance meniscal degenerations. J Orthop Surg (Hong Kong). 2019 May-Aug;27(2):2309499019852779. doi: 10.1177/2309499019852779.
- Background: PubMed 31897409Vilchez-Cavazos F, Millan-Alanis JM, Blazquez-Saldana J, Alvarez-Villalobos N, Pena-Martinez VM, Acosta-Olivo CA, Simental-Mendia M. Comparison of the Clinical Effectiveness of Single Versus Multiple Injections of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2019 Dec 16;7(12):2325967119887116. doi: 10.1177/2325967119887116. eCollection 2019 Dec.
- Background: PubMed 29996980Walsh MR, Nelson BJ, Braman JP, Yonke B, Obermeier M, Raja A, Reams M. Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up. J Shoulder Elbow Surg. 2018 Sep;27(9):1553-1563. doi: 10.1016/j.jse.2018.05.003. Epub 2018 Jul 9.
- Background: PubMed 23893418Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selma EROGLU, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single PRP Injection and Multiple PRP Injections in people with Shoulder Pain and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: up to 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561452, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.