Current partner codePEPTIDESDE
NCT06753630·Not applicable·INTERVENTIONAL

Polydeoxyribonucleotide for Elbow Lateral Epicondylitis

Status

Completed

Phase

Not applicable

Enrollment

48

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Dec 31, 2024

  2. Study start

    Nov 20, 2014

  3. Primary completion

    Nov 30, 2015

  4. Study completion

    Nov 30, 2016

  5. Results posted

    Not reported

  6. Registry updated

    Dec 31, 2024

Outcomes

What the study measures.

Primary outcomes

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

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.

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.

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.

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

South Korea. Showing up to 24 locations stored in the fast local snapshot.

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

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