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Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections Versus a Single Platelet-Rich Plasma Injection (PRPLE)

Primary Purpose

Tennis Elbow, Lateral Epicondylitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma Injection
Saline Injection
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring PRP, Platelet Rich Plasma, Lateral Epicondylitis, Lateral Epicondylopathy, Lateral Epicondylosis, Chronic Lateral Epicondylitis, PRPLE, Multiple PRP Injections, Multiple PRP, Platelet-Rich Plasma, Tennis Elbow, Double Blinded Randomized Controlled, Multiple vs Single PRP injections, prp tennis elbow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Lateral epicondylitis - diagnosed by orthopedic or sports medicine physicians / 2 separate examinations (examination at referral / confirmatory examination at time of injection)
  2. Pain at the lateral epicondyle on direct palpation
  3. Pain with resistive wrist extension and/or supination
  4. No clinical findings at annular ligament, radiocapitellar joint, or PIN (posterior interosseous nerve syndrome)
  5. No underlying bone pathology
  6. Symptoms present for > 3 months
  7. Visual analog score (VAS) that is >= 5/10
  8. Last steroid injection > 3 months
  9. Failed previous therapy (> = 4 weeks of strap, splint, cast, injection or any other accepted therapy without satisfactory pain or function)

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnant
  3. Symptomatic Carpal Tunnel syndrome on the affected side
  4. History of cervical radiculopathy
  5. History of Diabetes Mellitus, Rheumatoid Arthritis, hepatitis
  6. Blood disorder
  7. No immunocompromised patients (Human ImmunoDeficiency Virus, cancer, immunomodulator therapies)
  8. Oral Nonsteroidal Antiinflammatory in the past 1 week or Steroid Drug use in the past 3 months
  9. Participation in a workers' compensation program or planning to apply for the program and/or any ongoing, pending, or planned legal action as a result of elbow pain

Sites / Locations

  • Kaiser Permanente

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Multiple PRP Injection

Single PRP Injection

Saline Injection

Arm Description

2 PRP Injections 2 months apart

1 PRP Injection and Saline Injection 2 months apart

2 Saline Injections 2 months apart

Outcomes

Primary Outcome Measures

Pain
VAS Score
Function
DASH Score

Secondary Outcome Measures

Full Information

First Posted
January 16, 2015
Last Updated
June 15, 2018
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02343822
Brief Title
Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections Versus a Single Platelet-Rich Plasma Injection
Acronym
PRPLE
Official Title
Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections Versus a Single Platelet-Rich Plasma Injection in a Double-Blinded Randomized Controlled Study (PRPLE)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 20, 2016 (Actual)
Study Completion Date
September 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the ideal dose of PRP for lateral epicondylitis. To see if 2 PRP injections are better than a single PRP injection or a saline injection to improve function and pain in patients with lateral epicondylitis.
Detailed Description
Is there greater clinical improvement in long term pain and function when patients receive two PRP injections instead of one? This is a double-blinded randomized controlled study to determine the ideal treatment regimen for treatment of chronic lateral epicondylitis (tennis elbow). The investigators will compare pain visual analog scale (VAS) scores and functional Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire scores of patients receiving a single PRP injection and two PRP injections. The study will be conducted at Kaiser Modesto Sports Medicine involving 532 patients who meet strict criteria for chronic lateral epicondylitis (including greater than 2 months of chronic lateral epicondylitis and failing at least one other treatment modality). Patients are randomly divided between three groups: 234 patients will receive one PRP injection, 234 will receive two, and 64 in the control group will receive a saline injection. All participants will receive concurrent home based stretching and strengthening exercises. Results are to be measured using the Visual Analog Scale (VAS) and Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire on the initial and follow-up visits of 2, 6, and 12 months. Both measures have been validated by prior studies. Successful treatment of lateral epicondylitis will be defined as a 25% reduction in visual analog score VAS and DASH scores between initial and 6 month visits. Average control and experimental groups VAS scores are expected to be 8 out of 10 with an improvement to 7 and 6 respectively in 6 months. Average control and experimental group DASH scores are expected to be 49 with an improvement to 44 and 28 respectively in 6 months. PRP is an effective treatment in reducing pain of chronic lateral epicondylitis. This study aims to prove there is greater clinical improvement in long term pain and function when patients receive two PRP injections instead of one.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Lateral Epicondylitis
Keywords
PRP, Platelet Rich Plasma, Lateral Epicondylitis, Lateral Epicondylopathy, Lateral Epicondylosis, Chronic Lateral Epicondylitis, PRPLE, Multiple PRP Injections, Multiple PRP, Platelet-Rich Plasma, Tennis Elbow, Double Blinded Randomized Controlled, Multiple vs Single PRP injections, prp tennis elbow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple PRP Injection
Arm Type
Experimental
Arm Description
2 PRP Injections 2 months apart
Arm Title
Single PRP Injection
Arm Type
Experimental
Arm Description
1 PRP Injection and Saline Injection 2 months apart
Arm Title
Saline Injection
Arm Type
Active Comparator
Arm Description
2 Saline Injections 2 months apart
Intervention Type
Other
Intervention Name(s)
Platelet Rich Plasma Injection
Other Intervention Name(s)
PRP
Intervention Description
Plasma component of blood rich in growth factors -during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing
Intervention Type
Other
Intervention Name(s)
Saline Injection
Other Intervention Name(s)
Saline
Intervention Description
Saline -during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing
Primary Outcome Measure Information:
Title
Pain
Description
VAS Score
Time Frame
6 months
Title
Function
Description
DASH Score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Lateral epicondylitis - diagnosed by orthopedic or sports medicine physicians / 2 separate examinations (examination at referral / confirmatory examination at time of injection) Pain at the lateral epicondyle on direct palpation Pain with resistive wrist extension and/or supination No clinical findings at annular ligament, radiocapitellar joint, or PIN (posterior interosseous nerve syndrome) No underlying bone pathology Symptoms present for > 3 months Visual analog score (VAS) that is >= 5/10 Last steroid injection > 3 months Failed previous therapy (> = 4 weeks of strap, splint, cast, injection or any other accepted therapy without satisfactory pain or function) Exclusion Criteria: Age < 18 years Pregnant Symptomatic Carpal Tunnel syndrome on the affected side History of cervical radiculopathy History of Diabetes Mellitus, Rheumatoid Arthritis, hepatitis Blood disorder No immunocompromised patients (Human ImmunoDeficiency Virus, cancer, immunomodulator therapies) Oral Nonsteroidal Antiinflammatory in the past 1 week or Steroid Drug use in the past 3 months Participation in a workers' compensation program or planning to apply for the program and/or any ongoing, pending, or planned legal action as a result of elbow pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wais N Arsala, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Modesto
State/Province
California
ZIP/Postal Code
95356
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16400654
Citation
Anitua E, Sanchez M, Nurden AT, Zalduendo M, de la Fuente M, Orive G, Azofra J, Andia I. Autologous fibrin matrices: a potential source of biological mediators that modulate tendon cell activities. J Biomed Mater Res A. 2006 May;77(2):285-93. doi: 10.1002/jbm.a.30585.
Results Reference
background
PubMed Identifier
22972856
Citation
Krogh TP, Bartels EM, Ellingsen T, Stengaard-Pedersen K, Buchbinder R, Fredberg U, Bliddal H, Christensen R. Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials. Am J Sports Med. 2013 Jun;41(6):1435-46. doi: 10.1177/0363546512458237. Epub 2012 Sep 12.
Results Reference
result
PubMed Identifier
16735582
Citation
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.
Results Reference
result
PubMed Identifier
23825183
Citation
Mishra AK, Skrepnik NV, Edwards SG, Jones GL, Sampson S, Vermillion DA, Ramsey ML, Karli DC, Rettig AC. Efficacy of platelet-rich plasma for chronic tennis elbow: a double-blind, prospective, multicenter, randomized controlled trial of 230 patients. Am J Sports Med. 2014 Feb;42(2):463-71. doi: 10.1177/0363546513494359. Epub 2013 Jul 3.
Results Reference
result
PubMed Identifier
20448192
Citation
Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.
Results Reference
result
PubMed Identifier
21422467
Citation
Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
Results Reference
result
Citation
Arsala W, Sharpe F. Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections With No Greater Positive Effect Than A Single Platelet-Rich Plasma Injection. Med&Science in Sprts&Exercise. 2012 May44(5):S82
Results Reference
result
PubMed Identifier
937623
Citation
Kennedy JC, Willis RB. The effects of local steroid injections on tendons: a biomechanical and microscopic correlative study. Am J Sports Med. 1976 Jan-Feb;4(1):11-21. doi: 10.1177/036354657600400103. No abstract available.
Results Reference
result
PubMed Identifier
21562414
Citation
Taylor DW, Petrera M, Hendry M, Theodoropoulos JS. A systematic review of the use of platelet-rich plasma in sports medicine as a new treatment for tendon and ligament injuries. Clin J Sport Med. 2011 Jul;21(4):344-52. doi: 10.1097/JSM.0b013e31821d0f65.
Results Reference
result

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Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections Versus a Single Platelet-Rich Plasma Injection

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