Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

Chuncheon Sacred Heart Hospital

Status: Completed

Conditions: Extracorporeal Shockwave Therapy; Lateral Epicondylitis; Muscle Strengthening

Treatments: Procedure: Extracorporeal Shockwave Therapy; Drug: Saline injection (Octreotide LAR placebo); Drug: Polydeoxyribonucleotide Injection; Behavioral: Extensor Muscle Strengthening Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06753630

2014-100

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Group 1 (G1): EMSE + ESWT + Saline Injection

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Extensor Muscle Strengthening Exercise

Drug: Saline injection (Octreotide LAR placebo)

Procedure: Extracorporeal Shockwave Therapy

Group 2 (G2): EMSE + ESWT + PDRN Injection

Experimental group

Description:

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.

Treatment:

Behavioral: Extensor Muscle Strengthening Exercise

Drug: Polydeoxyribonucleotide Injection

Procedure: Extracorporeal Shockwave Therapy