Bundang Rehabilitative Impact Study of the Elbow Epicondylitis (BundangRISEe)

April 19, 2017 updated by: Jae-Young Lim, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-Do
      • SeongNam-Si, Gyeonggi-Do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • PDRN (Polydeoxyribonucleotide) sodium
Active Comparator: 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.
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.
Other Names:
  • 15% dextrose and 0.2% lidocaine solution, mixed, total 3ml
  • as prolotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Visual analog scale (VAS) as lateral elbow pain at 3 months
Time Frame: 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
0, 6 and 12 weeks, 3 times

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline PRTEE(Patient-Rated Tennis Elbow Evaluation) at 3 months
Time Frame: 0, 6 and 12 weeks, 3 times

PRTEE assesses the average pain and function of the affected arm during the preceding week. It consists of 2 parts, 1 assessing elbow pain (5 items) and 1 assessing function (10 items) using a numeric rating scale from 0 to 10, with 5 and 10 questions, respectively.

Scores range from 0 (good quality-of- life, no pain or disability) to 100 (poor quality-of-life, extreme pain or disability).
0, 6 and 12 weeks, 3 times
Change from Baseline EQ-5D-5L at 3 months
Time Frame: 0, 6 and 12 weeks, 3 times
EQ-5D-5L assess health-related quality of life(HRQOL) in tennis elbow patients. This is an instrument widely used to measure and evaluate general health status and describes general health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
0, 6 and 12 weeks, 3 times
Change from Baseline ASES elbow satisfaction at 3 months
Time Frame: 0, 6 and 12 weeks, 3 times
ASES(American Shoulder and Elbow Surgeons) elbow is a currently among the most commonly used elbow self-report pain and disability outcome measures and have 18 item self-report questionnaire designed to measure pain and disability arising from elbow disorders. But In this trial, only one questionnaire about satisfaction is used.
0, 6 and 12 weeks, 3 times
Change from Baseline PPT(pressure pain threshold) at 3 months
Time Frame: 0, 6 and 12 weeks, 3 times

PPT(pressure pain threshold, Kg/cm2 or lb ) is assessed by an algometry, Commander trademark. The algometry is comprised of a gauge attached to a hard rubber tip. Pressure was applied though the rubber surface area of 1 cm2 at a rate of 2 Kg/Cm2 per second.

second. The instrument was placed perpendicular to the skin's surface at lateral epicondyle (site of maximal tenderness). The participants were asked to indicate when the pressure became painful based on this definition: "When you feel the sensation changes from pressure to the slightest pain inform us". Each measure site was tested three times with 1 minutes between each test. Their average was used for statistical analyses.
0, 6 and 12 weeks, 3 times
Change from Baseline Hand grip strength at 3 months
Time Frame: 0, 6 and 12 weeks, 3 times
Its assessment is made by Takei digital hand grip dynamometer(unit = N ). For the actual testing procedure, pain-free grip strength measurements of the involved limb were conducted first. The subject was instructed to slowly squeeze the dynamometer and to stop the instant that changes from pressure to the slightest pain was experienced. Each measure site was tested three times with 1 minutes between each test. Their average was used for statistical analyses. Cf. pain-free maximum grip strength )
0, 6 and 12 weeks, 3 times
Change from Baseline Strength of wrist by isokinetic muscle performance test (IMPT) at 3 months
Time Frame: 0, 6 and 12 weeks, 3 times
Isometric resistance strength( unit = N ) was tested with Primus RS (BTE, Baltimore, USA)) device. 5 times repetitive movements in wrist flexion/extension and pronation/supination are performed at both side. And average torque is calculated by obtaining the mean value of the torque signal for 5 repetition.
0, 6 and 12 weeks, 3 times
Change from Baseline Ultrasound features of the Common extensor tendon at 3 months
Time Frame: 0, 6 and 12 weeks, 3 times
We used ACCUVIX V20 with an 5- to 13Hz broadband linear transducer ( SAMSUNG MEDICINE, Hongchun, Gangwondo). The transducer was aligned with the long axis of the radius over the common tendon origin. Diagnostic ultrasound of the common extensor tendon is first performed to evaluate the degree of tendinosis and to fully characterize tendon abnormalities. Seven ultrasound features of the Common extensor tendon are assessed as below. A. Grade of tendinosis, B. Tendon thickness, C. Radial collateral ligament(RCL) lesion, D. Tendon hyperemia (Power doppler), E. Cortical irregularity, F. Intratendinous calcification, G. Enthesophyte
0, 6 and 12 weeks, 3 times

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Hyun-Kyung Do, Seoul National University Bundang Hospital
  • Study Director: Jae-Young Lim, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1411/276-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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