Bundang Rehabilitative Impact Study of the Elbow Epicondylitis

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Lidocaine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

The inclusion criteria for the study are

• provision of informed consent by patient

• adult men or women aged > 18 and < 65 years

• Patients had a clinical diagnosis of lateral epicondylitis based on local tenderness to palpation at lateral epicondyle and pain in that area elicited with active extension of the wrist in pronation and elbow extension

• History of pain >3 months and <2 years, failed each of the following conservative care modalities: relative rest, physical/occupational therapy, non-steroidal anti-inflammatorydrugs and two corticosteroid injections.

• Baseline elbow pain > 50 mm/100 mm using a visual analog scale (VAS) with resisted active extension of the wrist in pronation and elbow extension

• All affected elbows were screened with radiography and all proved to be normal, except for some calcifications of the common extensor origin.

• documented sonographic diagnosis of common extensor tendinosis was based on tendon echogenicity, loss of the normal echotexture and tendon thickening. We also performed the sonographic assessment of the extensor carpi radialis brevis, extensor digitorum communis and radial collateral ligament; tendinosis defined as ill- or well-defined focal/generalized hypoechogenic swollen tendon with loss of normal fibrillary pattern and focal tear defined as well-defined anechoic cleft

Exclusion Criteria:

• History of narcotic use for pain management > 1 mo, narcotic abuse

• History of alcoholic abuse

• any recent febrile or infectious disease

• corticosteroid injection within the past 3 months

• Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, fracture or osteochondral lesion)

• History of carpal tunnel syndrome, cervical radiculopathy or neurologic disorder

• Other chronic widespread pain syndromes

• History of bleeding disorder, anemia

• Systemic disorders such as diabetes, rheumatoid arthritis,or hepatitis

• Intolerance/allergy to local anesthetics or injection corticosteroids

• history of vasovagal shock

• Pregnancy/lactation

• history of any malignancy (including hematologic and non hematologic malignancies)

• Hypotension, systolic BP <100mmHg, diastolic BP < 60mmHg

• Systemic disorders such as diabetes, rheumatoid arthritis, or hepatitis, nephropathy, Hypothyroidism.

• History of receiving a PDRN injection at any site

• Allergic reaction or hypersensitivity for PDRN

• Workers compensation or worker using both upper extremities, especially elbow and hand for most labor activity

• history of acute elbow trauma (<1 week)

• patients requiring antiplatelet medications for the treatment of heart attack, stroke, or other medical condition

• Previous surgery for elbow tendinosis or other disease at affected side

• Active bilateral elbow tendinosis within 4 weeks before randomization

• Tendon echogenicity, grade 0 and 4 were excluded; The degree of tendinosis is grade based on changes in tendon echotexture at sonographic assessment, Diagnostic ultrasound features for the RISEe