Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

Not Applicable

Completed

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

• Registration Number: NCT06753630
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-20
• Primary Completion: 2015-11-30
• Study Completion: 2016-11-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-21
• Last Update Submitted: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (G1): EMSE + ESWT + Saline Injection	Extensor Muscle Strengthening Exercise	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.
Group 1 (G1): EMSE + ESWT + Saline Injection	Extracorporeal Shockwave Therapy	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.
Group 1 (G1): EMSE + ESWT + Saline Injection	Saline injection (Octreotide LAR placebo)	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.
Group 2 (G2): EMSE + ESWT + PDRN Injection	Extensor Muscle Strengthening Exercise	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.
Group 2 (G2): EMSE + ESWT + PDRN Injection	Extracorporeal Shockwave Therapy	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.
Group 2 (G2): EMSE + ESWT + PDRN Injection	Polydeoxyribonucleotide 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.

Primary Outcome Measures

Name	Time	Method
Pain Reduction	Baseline, 6 weeks, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Functional Improvement	Baseline, 6 weeks, 12 weeks	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.
Grip Strength Improvement	Baseline, 6 weeks, 12 weeks	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.
Common Extensor Tendon Depth Measured by Ultrasonography	Baseline, 6 weeks, 12 weeks	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.
Color Doppler Activity Measured by Ultrasonography	Baseline, 6 weeks, 12 weeks	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

Trial Locations

Locations (1)

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of