NCT02343822

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2016

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

1.6 years

First QC Date

January 16, 2015

Last Update Submit

June 15, 2018

Conditions

Tennis ElbowLateral Epicondylitis

Keywords

PRPPlatelet Rich PlasmaLateral EpicondylitisLateral EpicondylopathyLateral EpicondylosisChronic Lateral EpicondylitisPRPLEMultiple PRP InjectionsMultiple PRPPlatelet-Rich PlasmaTennis ElbowDouble Blinded Randomized ControlledMultiple vs Single PRP injectionsprp tennis elbow

Outcome Measures

Primary Outcomes (2)

  • Pain

    VAS Score

    6 months

  • Function

    DASH Score

    6 months

Study Arms (3)

Multiple PRP Injection

EXPERIMENTAL

2 PRP Injections 2 months apart

Other: Platelet Rich Plasma Injection

Single PRP Injection

EXPERIMENTAL

1 PRP Injection and Saline Injection 2 months apart

Other: Platelet Rich Plasma InjectionOther: Saline Injection

Saline Injection

ACTIVE COMPARATOR

2 Saline Injections 2 months apart

Other: Saline Injection

Interventions

Platelet Rich Plasma InjectionOTHER

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

Also known as: PRP
Multiple PRP InjectionSingle PRP Injection
Saline InjectionOTHER

Saline -during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing

Also known as: Saline
Saline InjectionSingle PRP Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Modesto, California, 95356, United States

Location

Related Publications (9)

  • 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.

    PMID: 16400654BACKGROUND

  • 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.

    PMID: 22972856RESULT

  • 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.

    PMID: 16735582RESULT

  • 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.

    PMID: 23825183RESULT

  • 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.

    PMID: 20448192RESULT

  • 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.

    PMID: 21422467RESULT

  • 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

    RESULT

  • 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.

    PMID: 937623RESULT

  • 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.

    PMID: 21562414RESULT

MeSH Terms

Conditions

Tennis Elbow

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Wais N Arsala, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

March 1, 2015

Primary Completion

September 20, 2016

Study Completion

September 20, 2016

Last Updated

June 18, 2018

Record last verified: 2018-06

Locations

US(1)