Bundang Rehabilitative Impact Study of the Elbow Epicondylitis

NCT02492945 | Completed Phase 4 DMC

• 1 other identifier: B-1411/276-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Lateral Epicondylitis

Keywords

Tennis elbow; Polydeoxyribonucleotides; Prolotherapy; Randomized controlled trial; Visual analogue scale; disability; ultrasonography

Outcome Measures

Primary Outcomes (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

  0, 6 and 12 weeks, 3 times

Secondary Outcomes (7)

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

  0, 6 and 12 weeks, 3 times

• Change from Baseline EQ-5D-5L 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

• Change from Baseline Hand grip strength at 3 months

  0, 6 and 12 weeks, 3 times

Study Arms (2)

PDRN group

EXPERIMENTAL

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

Dextrose group

ACTIVE COMPARATOR

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

Interventions

3ml-Rejuvinex DRUG

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.

Also known as: PDRN (Polydeoxyribonucleotide) sodium

PDRN group

3ml-15%-dextrose solution DRUG

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.

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

Dextrose group

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (20)

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• Polito F, Bitto A, Galeano M, Irrera N, Marini H, Calo M, Squadrito F, Altavilla D. Polydeoxyribonucleotide restores blood flow in an experimental model of ischemic skin flaps. J Vasc Surg. 2012 Feb;55(2):479-88. doi: 10.1016/j.jvs.2011.07.083. Epub 2011 Nov 3.

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• Carayannopoulos A, Borg-Stein J, Sokolof J, Meleger A, Rosenberg D. Prolotherapy versus corticosteroid injections for the treatment of lateral epicondylosis: a randomized controlled trial. PM R. 2011 Aug;3(8):706-15. doi: 10.1016/j.pmrj.2011.05.011.

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• Chiavaras MM, Jacobson JA, Carlos R, Maida E, Bentley T, Simunovic N, Swinton M, Bhandari M. IMpact of Platelet Rich plasma OVer alternative therapies in patients with lateral Epicondylitis (IMPROVE): protocol for a multicenter randomized controlled study: a multicenter, randomized trial comparing autologous platelet-rich plasma, autologous whole blood, dry needle tendon fenestration, and physical therapy exercises alone on pain and quality of life in patients with lateral epicondylitis. Acad Radiol. 2014 Sep;21(9):1144-55. doi: 10.1016/j.acra.2014.05.003. Epub 2014 Jul 9.

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MeSH Terms

Conditions

Tennis Elbow

Interventions

Polydeoxyribonucleotides; Sodium; Glucose; Prolotherapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Hexoses; Monosaccharides; Sugars; Carbohydrates; Complementary Therapies; Therapeutics

Study Officials

• Hyun-Kyung Do

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Jae-Young Lim

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient with elbow epicondylitis in randomized double-blind active-control comparative study

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)