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Bundang Rehabilitative Impact Study of the Elbow Epicondylitis (BundangRISEe)

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
3ml-Rejuvinex
3ml-15%-dextrose solution
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Tennis elbow, Polydeoxyribonucleotides, Prolotherapy, Randomized controlled trial, Visual analogue scale, disability, ultrasonography

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PDRN group

Dextrose group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
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.
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.
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 )
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.
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

Full Information

First Posted
June 26, 2015
Last Updated
April 19, 2017
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02492945
Brief Title
Bundang Rehabilitative Impact Study of the Elbow Epicondylitis
Acronym
BundangRISEe
Official Title
Safety and Effects of PDRN(Polydeoxyribonucleotide) Injection in Patient With Elbow Epicondylitis in Randomized Double-blind Active-control Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Tennis elbow, Polydeoxyribonucleotides, Prolotherapy, Randomized controlled trial, Visual analogue scale, disability, ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PDRN group
Arm Type
Experimental
Arm Description
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.
Arm Title
Dextrose group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
3ml-Rejuvinex
Other Intervention Name(s)
PDRN (Polydeoxyribonucleotide) sodium
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
3ml-15%-dextrose solution
Other Intervention Name(s)
15% dextrose and 0.2% lidocaine solution, mixed, total 3ml, as prolotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Visual analog scale (VAS) as lateral elbow pain at 3 months
Description
Visual analog scale (100-mm VAS) with resisted active extension of the wrist in radial deviation, pronation and elbow extension
Time Frame
0, 6 and 12 weeks, 3 times
Secondary Outcome Measure Information:
Title
Change from Baseline PRTEE(Patient-Rated Tennis Elbow Evaluation) at 3 months
Description
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).
Time Frame
0, 6 and 12 weeks, 3 times
Title
Change from Baseline EQ-5D-5L at 3 months
Description
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.
Time Frame
0, 6 and 12 weeks, 3 times
Title
Change from Baseline ASES elbow satisfaction at 3 months
Description
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.
Time Frame
0, 6 and 12 weeks, 3 times
Title
Change from Baseline PPT(pressure pain threshold) at 3 months
Description
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.
Time Frame
0, 6 and 12 weeks, 3 times
Title
Change from Baseline Hand grip strength at 3 months
Description
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 )
Time Frame
0, 6 and 12 weeks, 3 times
Title
Change from Baseline Strength of wrist by isokinetic muscle performance test (IMPT) at 3 months
Description
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.
Time Frame
0, 6 and 12 weeks, 3 times
Title
Change from Baseline Ultrasound features of the Common extensor tendon at 3 months
Description
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
Time Frame
0, 6 and 12 weeks, 3 times

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Kyung Do
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
SeongNam-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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Bundang Rehabilitative Impact Study of the Elbow Epicondylitis

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