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Completed

NCT Number: NCT06753630

Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

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

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Extracorporeal Shockwave Therapy Muscle Strengthening Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extensor Muscle Strengthening Exercise

Behavioral

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

Extracorporeal Shockwave Therapy

Procedure

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

Saline injection (Octreotide LAR placebo)

Drug

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

Polydeoxyribonucleotide Injection

Drug

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

Primary outcomes

  1. Pain Reduction

    Time frame: 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 outcomes

  1. Functional Improvement

    Time frame: 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.

  2. Grip Strength Improvement

    Time frame: 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.

  3. Common Extensor Tendon Depth Measured by Ultrasonography

    Time frame: 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.

  4. Color Doppler Activity Measured by Ultrasonography

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

Does Combined Polydeoxyribonucleotide Improve the Outcome of Extensor Muscle Strengthening Exercise with Extracorporeal Shockwave Therapy for Lateral Epicondylitis of Elbow?: a Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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