The Efficacy of PRP Injection in the Treatment of Rotator Cuff Syndrome

NCT05561452 | Completed

• 1 other identifier: ROTCUFFPRP2022
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Pain; Musculoskeletal Diseases; Rotator Cuff Tendinopathy; Rotator Cuff Syndrome

Keywords

Platelet rich plasma ( PRP); Subacromial injection; Rotator cuff tendinopathy; Rotator Cuff Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Shoulder Pain and Disability Index (SPADI)

  up to 12th week

• The 36-item Short Form Health Survey（SF-36）

  up to 12th week

• Range of Motion（ROM）

  up to 12th week

• Constant Murley Score (C-MS)

  up to 12th week

• Isokinetic Test

  up to 12th week

Study Arms (3)

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.

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.

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.

Other: Placebo Injection

Interventions

Single PRP Injection OTHER

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.

Single PRP Injection + Exercise

Multiple PRP Injections OTHER

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.

Multiple PRP Injection+ Exercise

Placebo Injection OTHER

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.

Saline Injection + Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahi̇sar, 03200, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 31875061 BACKGROUND

• Hurley 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.

  PMID: 31000394 BACKGROUND

• Kim 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.

  PMID: 20439653 BACKGROUND

• Ozyalvac 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.

  PMID: 31204581 BACKGROUND

• Vilchez-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.

  PMID: 31897409 BACKGROUND

• Walsh 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.

  PMID: 29996980 BACKGROUND

• Kesikburun 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.

  PMID: 23893418 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selma EROGLU, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant doctor

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: September 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: June 25, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)