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Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

NCT06753630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-31

No results posted yet for this study

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

Conditions

  • Lateral Epicondylitis
  • Extracorporeal Shockwave Therapy
  • Muscle Strengthening

Interventions

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.

DRUG

Polydeoxyribonucleotide Injection

A 3mL injection of polydeoxyribonucleotide (5.625mg/3mL) used to enhance the healing process and improve outcomes in lateral epicondylitis treatment.

Sponsors & Collaborators

  • Chuncheon Sacred Heart Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-20
Primary Completion
2015-11-30
Completion
2016-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06753630 on ClinicalTrials.gov