NCT02492945

Bundang Rehabilitative Impact Study of the Elbow Epicondylitis

Safety and Effects of PDRN(Polydeoxyribonucleotide) Injection in Patient With Elbow Epicondylitis in Randomized Double-blind Active-control Comparative Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Not accepted

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

Detailed description

Detailed Description: 40 patients that meet the inclusion criteria on screening test are assigned to one of two groups(PDRN group or 15% dextrose active control group) by randomization. They take the three times of the ultrasonography-guided injections for four weeks(0,2,4 weeks) under double-blind. PDRN group take ultrasonography-guided 3ml PDRN injection for the lesion( tear or tendinosis about extensor carpi radialis brevis, extensor digitorum communis, radial collateral ligament ) of lateral epicondylitis for 4 weeks. Active control group takes the 15% dextrose solution, 3ml for same procedure. The main outcome variables are measured at 0, 6 weeks and 3 months after 1st injection as starting point and compared differences from baseline to 3 month as primary end points within each group or between both group. Polydeoxyribonucleotide is verified whether it has the safety and effect on lateral epicondylitis with comparing to prolotherapy.

Conditions

• Lateral Epicondylitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2015-07-09
• Last updated: 2017-04-20

Locations

1 site across 1 country: South Korea