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BundangRISEe: Bundang Rehabilitative Impact Study of the Elbow Epicondylitis

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02492945
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
16
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Safety and Effects of PDRN(Polydeoxyribonucleotide) Injection in Patient With Elbow Epicondylitis in Randomized Double-blind Active-control Comparative Study
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Visual analog scale (VAS) as lateral elbow pain at 3 months [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

    Secondary Outcome Measures

    1. Change from Baseline PRTEE(Patient-Rated Tennis Elbow Evaluation) at 3 months [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).

    2. Change from Baseline EQ-5D-5L at 3 months [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.

    3. Change from Baseline ASES elbow satisfaction at 3 months [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.

    4. Change from Baseline PPT(pressure pain threshold) at 3 months [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.

    5. Change from Baseline Hand grip strength at 3 months [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 )

    6. Change from Baseline Strength of wrist by isokinetic muscle performance test (IMPT) at 3 months [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.

    7. Change from Baseline Ultrasound features of the Common extensor tendon at 3 months [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital SeongNam-Si Gyeonggi-Do Korea, Republic of 463-707

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    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
    ClinicalTrials.gov Identifier:
    NCT02492945
    Other Study ID Numbers:
    • B-1411/276-004
    First Posted:
    Jul 9, 2015
    Last Update Posted:
    Apr 20, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by 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
    Tennis elbow
    Polydeoxyribonucleotides
    Prolotherapy
    Randomized controlled trial
    Visual analogue scale
    disability
    ultrasonography
    Additional relevant MeSH terms:
    Tennis Elbow
    Lidocaine
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Apr 20, 2017