Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

NCT06753630 | Completed

• 1 other identifier: 2014-100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Lateral Epicondylitis; Extracorporeal Shockwave Therapy; Muscle Strengthening

Keywords

Polydeoxyribonucleotide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Improvement

  Baseline, 6 weeks, 12 weeks

• Grip Strength Improvement

  Baseline, 6 weeks, 12 weeks

• Common Extensor Tendon Depth Measured by Ultrasonography

  Baseline, 6 weeks, 12 weeks

• Color Doppler Activity Measured by Ultrasonography

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

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

PLACEBO COMPARATOR

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; Procedure: Extracorporeal Shockwave Therapy; Drug: Saline injection (Octreotide LAR placebo)

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

EXPERIMENTAL

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; Procedure: Extracorporeal Shockwave Therapy; Drug: Polydeoxyribonucleotide Injection

Interventions

Extensor Muscle Strengthening Exercise BEHAVIORAL

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

Group 1 (G1): EMSE + ESWT + Saline Injection; Group 2 (G2): EMSE + ESWT + PDRN Injection

Extracorporeal Shockwave Therapy PROCEDURE

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

Group 1 (G1): EMSE + ESWT + Saline Injection; Group 2 (G2): EMSE + ESWT + PDRN Injection

Saline injection (Octreotide LAR placebo) DRUG

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

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

Polydeoxyribonucleotide Injection DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave Therapy; Sodium Chloride; Polydeoxyribonucleotides

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 31, 2024
• Study Start: November 20, 2014
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2016
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)