Clinical trial NCT02492945: Bundang Rehabilitative Impact Study of the Elbow Epicondylitis
Official title: Safety and Effects of PDRN(Polydeoxyribonucleotide) Injection in Patient With Elbow Epicondylitis in Randomized Double-blind Active-control Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lateral Epicondylitis
Keywords: Tennis elbow
Polydeoxyribonucleotides
Prolotherapy
Randomized controlled trial
Visual analogue scale
disability
ultrasonography
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline Visual analog scale (VAS) as lateral elbow pain at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
Secondary outcomes:
measure: Change from Baseline PRTEE(Patient-Rated Tennis Elbow Evaluation) at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
measure: Change from Baseline EQ-5D-5L at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
measure: Change from Baseline ASES elbow satisfaction at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
measure: Change from Baseline PPT(pressure pain threshold) at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
measure: Change from Baseline Hand grip strength at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
measure: Change from Baseline Strength of wrist by isokinetic muscle performance test (IMPT) at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
measure: Change from Baseline Ultrasound features of the Common extensor tendon at 3 months
timeFrame: 0, 6 and 12 weeks, 3 times
Other outcomes:
Locations:
city: SeongNam-Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-Do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyun-Kyung Do
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Jae-Young Lim
role: STUDY_DIRECTOR
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