Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

NCT ID: NCT06753630

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-20

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Lateral Epicondylitis Extracorporeal Shockwave Therapy Muscle Strengthening

Keywords

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Polydeoxyribonucleotide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Extensor Muscle Strengthening Exercise

Intervention Type BEHAVIORAL

A series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis.

Extracorporeal Shockwave Therapy

Intervention Type PROCEDURE

A non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area.

Saline injection (Octreotide LAR placebo)

Intervention Type DRUG

A 3mL injection of saline solution used as a placebo in the study.

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.

Group Type EXPERIMENTAL

Extensor Muscle Strengthening Exercise

Intervention Type BEHAVIORAL

A series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis.

Extracorporeal Shockwave Therapy

Intervention Type PROCEDURE

A non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area.

Polydeoxyribonucleotide Injection

Intervention Type DRUG

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

Interventions

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Extensor Muscle Strengthening Exercise

A series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis.

Intervention Type BEHAVIORAL

Extracorporeal Shockwave Therapy

A non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area.

Intervention Type PROCEDURE

Saline injection (Octreotide LAR placebo)

A 3mL injection of saline solution used as a placebo in the study.

Intervention Type DRUG

Polydeoxyribonucleotide Injection

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Taek Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2014-100

Identifier Type: -

Identifier Source: org_study_id