Safety and Effects of PDRN(Polydeoxyribonucleotide) Injection in Patient With Elbow Epicondylitis in Randomized Double-blind Active-control Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline Visual analog scale (VAS) as lateral elbow pain at 3 months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PDRN group
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-Rejuvinex injection for the lesion( tear or tendinosis about extensor carpi radialis brevis, extensor digitorum communis, radial collateral ligament ) of lateral epicondylitis for 4 weeks.
干预措施: 3ml-Rejuvinex (Drug)
Dextrose group
They take the three times of the ultrasonography-guided injections for four weeks(0,2,4 weeks) under double-blind. Dextrose group as active control group takes the 3ml-15%-dextrose solution for same procedure: the lesion( tear or tendinosis about extensor carpi radialis brevis, extensor digitorum communis, radial collateral ligament ) of lateral epicondylitis for 4 weeks. This dextrose solution for common extensor tendons are used as prolotherapy.
干预措施: 3ml-15%-dextrose solution (Drug)
结局指标
主要结局
Change from Baseline Visual analog scale (VAS) as lateral elbow pain at 3 months
时间窗: 0, 6 and 12 weeks, 3 times
Visual analog scale (100-mm VAS) with resisted active extension of the wrist in radial deviation, pronation and elbow extension
次要结局
- Change from Baseline EQ-5D-5L at 3 months(0, 6 and 12 weeks, 3 times)
- Change from Baseline Hand grip strength at 3 months(0, 6 and 12 weeks, 3 times)
- Change from Baseline Ultrasound features of the Common extensor tendon at 3 months(0, 6 and 12 weeks, 3 times)
- Change from Baseline PRTEE(Patient-Rated Tennis Elbow Evaluation) at 3 months(0, 6 and 12 weeks, 3 times)
- Change from Baseline Strength of wrist by isokinetic muscle performance test (IMPT) at 3 months(0, 6 and 12 weeks, 3 times)
- Change from Baseline ASES elbow satisfaction at 3 months(0, 6 and 12 weeks, 3 times)
- Change from Baseline PPT(pressure pain threshold) at 3 months(0, 6 and 12 weeks, 3 times)
研究者
Jae-Young Lim
Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient with elbow epicondylitis in randomized double-blind active-control comparative study
Seoul National University Bundang Hospital