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Lateral EpicondylitisPhase 4BundangRISEeNCT02492945

Bundang Rehabilitative Impact Study of the Elbow Epicondylitis

A Phase 4 study testing 3ml-Rejuvinex and 3ml-15%-dextrose solution in people with Lateral Epicondylitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 64 years
Conditions the study is for
Lateral Epicondylitis
What is being tested?
3ml-Rejuvinex and 3ml-15%-dextrose solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
Jun 2015to Oct 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

Official title: 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

Read more

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

Read the 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.

Being tested
3ml-Rejuvinex, 3ml-15%-dextrose solution
Keywords
Tennis elbow, Polydeoxyribonucleotides, Prolotherapy, Randomized controlled trial, Visual analogue scale, disability, ultrasonography
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3ml-RejuvinexDrug

    Also called PDRN (Polydeoxyribonucleotide) sodium

    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.

  • 3ml-15%-dextrose solutionDrug

    Also called 15% dextrose and 0.2% lidocaine solution, mixed, total 3ml, as prolotherapy

    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.

Study groups in NCT02492945
Study groupRoleWhat they receive
PDRN groupExperimentalThey 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.
Receives: Drug: 3ml-Rejuvinex
Dextrose groupActive comparatorThey 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.
Receives: Drug: 3ml-15%-dextrose solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Visual analog scale (100-mm VAS) with resisted active extension of the wrist in radial deviation, pronation and elbow extension

    Measured: 0, 6 and 12 weeks, 3 times

Secondary outcomes (7)

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

    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).

    Measured: 0, 6 and 12 weeks, 3 times

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

    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.

    Measured: 0, 6 and 12 weeks, 3 times

  3. Change from Baseline ASES elbow satisfaction at 3 months

    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.

    Measured: 0, 6 and 12 weeks, 3 times

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

    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.

    Measured: 0, 6 and 12 weeks, 3 times

  5. Change from Baseline Hand grip strength at 3 months

    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 )

    Measured: 0, 6 and 12 weeks, 3 times

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

    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.

    Measured: 0, 6 and 12 weeks, 3 times

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

    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

    Measured: 0, 6 and 12 weeks, 3 times

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionSep 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02492945
Sponsor's protocol ID
B-1411/276-004
Acronym
BundangRISEe
Status last verified
Feb 2017
First submitted
26 Jun 2015
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.

    PubMed 20970844

  • Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.

    PubMed 17910298

  • Price R, Sinclair H, Heinrich I, Gibson T. Local injection treatment of tennis elbow--hydrocortisone, triamcinolone and lignocaine compared. Br J Rheumatol. 1991 Feb;30(1):39-44. doi: 10.1093/rheumatology/30.1.39.

    PubMed 1991216

  • Sanchez M, Azofra J, Anitua E, Andia I, Padilla S, Santisteban J, Mujika I. Plasma rich in growth factors to treat an articular cartilage avulsion: a case report. Med Sci Sports Exerc. 2003 Oct;35(10):1648-52. doi: 10.1249/01.MSS.0000089344.44434.50.

    PubMed 14523300

  • Solveborn SA, Buch F, Mallmin H, Adalberth G. Cortisone injection with anesthetic additives for radial epicondylalgia (tennis elbow). Clin Orthop Relat Res. 1995 Jul;(316):99-105.

    PubMed 7634730

  • Maffulli N, Longo UG, Denaro V. Novel approaches for the management of tendinopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2604-13. doi: 10.2106/JBJS.I.01744.

    PubMed 21048180

  • Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.

    PubMed 16735582

  • Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19.

    PubMed 19380129

  • Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices. Am J Sports Med. 2007 Feb;35(2):245-51. doi: 10.1177/0363546506294078. Epub 2006 Nov 12.

    PubMed 17099241

  • Slater M, Patava J, Kingham K, Mason RS. Involvement of platelets in stimulating osteogenic activity. J Orthop Res. 1995 Sep;13(5):655-63. doi: 10.1002/jor.1100130504.

    PubMed 7472743

  • Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil Rehabil. 2008;30(20-22):1584-9. doi: 10.1080/09638280801906081.

    PubMed 18608363

  • Jacobson KA, Gao ZG. Adenosine receptors as therapeutic targets. Nat Rev Drug Discov. 2006 Mar;5(3):247-64. doi: 10.1038/nrd1983.

    PubMed 16518376

  • Cronstein BN. Adenosine, an endogenous anti-inflammatory agent. J Appl Physiol (1985). 1994 Jan;76(1):5-13. doi: 10.1152/jappl.1994.76.1.5.

    PubMed 8175547

  • Hasko G, Szabo C, Nemeth ZH, Kvetan V, Pastores SM, Vizi ES. Adenosine receptor agonists differentially regulate IL-10, TNF-alpha, and nitric oxide production in RAW 264.7 macrophages and in endotoxemic mice. J Immunol. 1996 Nov 15;157(10):4634-40.

    PubMed 8906843

  • Montesinos MC, Desai A, Delano D, Chen JF, Fink JS, Jacobson MA, Cronstein BN. Adenosine A2A or A3 receptors are required for inhibition of inflammation by methotrexate and its analog MX-68. Arthritis Rheum. 2003 Jan;48(1):240-7. doi: 10.1002/art.10712.

    PubMed 12528125

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3ml-Rejuvinex and 3ml-15%-dextrose solution in people with Lateral Epicondylitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Visual analog scale (VAS) as lateral elbow pain at 3 months (time frame: 0, 6 and 12 weeks, 3 times). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02492945, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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