Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

Does Combined Polydeoxyribonucleotide Improve the Outcome of Extensor Muscle Strengthening Exercise with Extracorporeal Shockwave Therapy for Lateral Epicondylitis of Elbow?: a Randomized Controlled Trial

The goal of this clinical trial is to investigate the synergistic effect of polydeoxyribonucleotide (PDRN) on extensor muscle strengthening exercise (EMSE) combined with extracorporeal shockwave therapy (ESWT) for treating lateral epicondylitis (LE) of the elbow in adults aged 18 to 65 years. The main questions it aims to answer are:

Does the addition of PDRN improve pain reduction as measured by the Visual Analog Scale (VAS)? Does the addition of PDRN enhance functional outcomes such as the Mayo Elbow Performance Score (MEPS) and Hand Grip Strength Index (HGSI)?

Researchers will compare two groups to see if PDRN provides additional benefits:

Group 1: EMSE + ESWT + saline injection Group 2: EMSE + ESWT + PDRN injection

Participants will:

Perform extensor muscle strengthening exercises Receive extracorporeal shockwave therapy Receive either a saline injection or a PDRN injection at the first outpatient department visit Attend follow-up visits at 6 and 12 weeks for assessments

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis; Extracorporeal Shockwave Therapy; Muscle Strengthening
• Intervention / Treatment: Behavioral: Extensor Muscle Strengthening Exercise; Procedure: Extracorporeal Shockwave Therapy; Drug: Saline injection (Octreotide LAR placebo); Drug: Polydeoxyribonucleotide Injection

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 24253
      • Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adults aged 18 to 65 years Diagnosed with chronic lateral epicondylitis (LE) of the elbow Willing to perform extensor muscle strengthening exercises Able to attend follow-up visits at 6 and 12 weeks

Exclusion Criteria:

History of elbow surgery Significant trauma to the elbow Current use of corticosteroids for LE Current use of other treatments for LE Pregnant or breastfeeding women Participation in another clinical trial within the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1 (G1): EMSE + ESWT + Saline Injection; Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL saline injection at the first outpatient department visit.	Behavioral: Extensor Muscle Strengthening Exercise; A series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis.; Procedure: Extracorporeal Shockwave Therapy; A non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area.; Drug: Saline injection (Octreotide LAR placebo); A 3mL injection of saline solution used as a placebo in the study.
Experimental: Group 2 (G2): EMSE + ESWT + PDRN Injection; Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL injection of polydeoxyribonucleotide (PDRN) at the first outpatient department visit.	Behavioral: Extensor Muscle Strengthening Exercise; A series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis.; Procedure: Extracorporeal Shockwave Therapy; A non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area.; Drug: Polydeoxyribonucleotide Injection; A 3mL injection of polydeoxyribonucleotide (5.625mg/3mL) used to enhance the healing process and improve outcomes in lateral epicondylitis treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Reduction	Pain Reduction as measured by the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain.	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Improvement	Improvement in elbow function as measured by the Mayo Elbow Performance Score (MEPS). This score ranges from 0 to 100, with higher scores indicating better elbow function. The MEPS assesses pain, range of motion, stability, and daily function.	Baseline, 6 weeks, 12 weeks
Grip Strength Improvement	Increase in hand grip strength as measured by the Hand Grip Strength Index (HGSI). HGSI is calculated as the ratio of affected side hand grip strength (in Newtons, N) to unaffected side hand grip strength (in Newtons, N). The index does not have predefined minimum or maximum values, as it is a relative measure. Higher values indicate greater improvement in grip strength on the affected side relative to the unaffected side.	Baseline, 6 weeks, 12 weeks
Common Extensor Tendon Depth Measured by Ultrasonography	Common Extensor Tendon Depth (CETD): Changes in common extensor tendon depth (units: millimeters, mm) as measured by ultrasonography. This measure assesses the structural changes in the tendon.	Baseline, 6 weeks, 12 weeks
Color Doppler Activity Measured by Ultrasonography	Color Doppler Activity (CDA): Changes in color Doppler activity as measured by ultrasonography. This measure assesses the vascular changes in the tendon. Changes in CDA as measured by ultrasonography. CDA was graded on a scale from 0 to 4 within a 0.5-cm longitudinal part of the tendon with maximal Doppler activity. The grading criteria are as follows: Grade 0: No activity; Grade 1: Single vessel in the region of interest (ROI); Grade 2: <25% of the ROI; Grade 3: 25%-50% of the ROI; Grade 4: >50% of the ROI	Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2014
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Polydeoxyribonucleotide
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: 2014-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No