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Bundang Rehabilitative Impact Study of the Elbow Epicondylitis

NCT02492945 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-04-20

No results posted yet for this study

Summary

This study is to assess the safety and effect of polydeoxyribonucleotide(PDRN) on the lateral epicondylitis with ultrasonography-guided injection of the PDRN or dextrose solution.

Condition: lateral epicondylitis

Intervention Drug: polydeoxyribonucleotide, PDRN Drug: dextrose solution, 15% as prolotherapy, active control

Phase 4

Study type: Interventional

Study design: Treatment, Parallel Assignment, Double Blind((Subject, intervention performer, Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study

Official Title: Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient with elbow epicondylitis in randomized double-blind active-control comparative study

Estimated Enrollment: 40

Conditions

  • Lateral Epicondylitis

Interventions

DRUG

3ml-Rejuvinex

They take the three times of the ultrasonography-guided 3ml-Rejuvinex as a PDRN group for four weeks(0,2,4 weeks) under double-blind.

DRUG

3ml-15%-dextrose solution

They take the three times of the ultrasonography-guided 3ml-15%-dextrose solution injections as a Dextrose group for four weeks(0,2,4 weeks) under double-blind.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Hyun-Kyung Do · Seoul National University Bundang Hospital

  • Jae-Young Lim · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-09-30
Completion
2016-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02492945 on ClinicalTrials.gov