Polydeoxyribonucleotide injection in the patients with partial-thickness tear of supraspinatus tendon: a prospective and pilot study using ultrasound

ABSTRACT

Objective: Polydeoxyribonucleotide as adenosine receptor (A_2A) agonist has been used in plastic surgery and dermatology related to its regenerative property. The aim of this pilot study is to evaluate the safety and efficacy of polydeoxynucleotide injection in patients with rotator cuff tears by a variety of outcomes including pain, disability, physical performance test, and ultrasonography (US).

Methods: Seventeen patients (9 men, 8 women, age: 57.9 ± 9.1) with partial-thickness tear of supraspinatus tendon were evaluated in a prospective, open-label, and pre-and-post study. Seventeen patients underwent 3 times intra-lesional polydeoxynucleotide injection under ultrasound (US) guidance on weeks 0, 2 and 4. The safety and efficacy were assessed on weeks 0, 6 and 12. Main outcome measures included shoulder pain on Visual Analogue Scale (VAS) and DASH (disabilities of arm, hand, shoulder) score, range of motion in shoulder, shoulder strength and tear volume (cm³) by US. Adverse events were monitored. (CRIS: https://www.cris.nih.go.kr, KCT0000767).

Results: Active shoulder pain on VAS reduced from 5.53 to 3.53 (P = 0.016), and acting pain, one of DASH questionnaires, reduced from 3.35 to 2.00 (P < 0.001). However, resting shoulder pain on VAS and total DASH scores were not significantly different. Forward flexion and internal rotation in range of motion improved significantly (from 169.41 to 178.13 degrees [P = 0.004] and from 83.53 to 88.75 degrees [P = 0.014], respectively). The volume of torn lesion decreased during the study period, however it was not significant. There were no significant adverse events leading to hospitalization.

Conclusions: Minimally invasive procedure through polydeoxynucleotide injection into torn area of supraspinatus tendon on US could be candidate for the safe and effective treatment on shoulder pain and limited range of motion in patients with rotator cuff tear.

KEYWORDS:

• Polydeoxyribonucleotide
• rotator cuff tear
• ultrasonography (US)
• minimally invasive procedure
• regeneration

Acknowledgments

No assistance in the preparation of this article is to be declared.

Declaration of interest

The authors have no relevant conflicts of interest to disclose. Peer reviewers on this manuscript have received an honorarium from PGM for their review work, but have no other relevant financial relationships to disclose.

Ethics approval and consent to participate

The present study protocol was reviewed and approved by the Institutional Review Boards and independent Ethics Committees at the participating institutions, Good Clinical Practice guidelines and any local requirements (IRB No. B-1301/187-003). All patients provided written informed consent before enrollment of the patient into the study. The study protocol was registered at clinical research information service (CRIS, https://cris.nih.go.kr), number KCT 0000767.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author contributions

Hyun-Kyung Do (Do HK) and Joong-Hoon Lee (Lee JH) contributed equally to this work.

Conceptualization and data curation: Lee JH, Formal analysis and article writer: Do HK.

Additional information

Funding

This study was an Investigator-Initiated Trial supported by Pharma Research Products (Grant number: 06-2013-068). All of the PDRN injections was donated by Pharma Research Products. Pharma Research Products did not contribute in the design of the study, collection, interpretation of data nor writing of the manuscript.