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Tennis ElbowPRPLENCT02343822

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

A study testing Platelet Rich Plasma Injection and Saline Injection in people with Tennis Elbow and Lateral Epicondylitis, run by Kaiser Permanente at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tennis Elbow, Lateral Epicondylitis
What is being tested?
Platelet Rich Plasma Injection and Saline Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
Mar 2015to 20 Sep 2016
Phase
Interventional
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kaiser Permanente

    Modesto, California, 95356

Other trials in United States

About this study

Official title: Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections Versus a Single Platelet-Rich Plasma Injection in a Double-Blinded Randomized Controlled Study (PRPLE)

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.

Read the 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.

Being tested
Platelet Rich Plasma Injection, Saline Injection
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
Medical subject headings
Tennis Elbow

What participants receive

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

  • Platelet Rich Plasma InjectionOther

    Also called PRP

    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

  • Saline InjectionOther

    Also called Saline

    Saline

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

Study groups in NCT02343822
Study groupRoleWhat they receive
Multiple PRP InjectionExperimental2 PRP Injections 2 months apart
Receives: Other: Platelet Rich Plasma Injection
Single PRP InjectionExperimental1 PRP Injection and Saline Injection 2 months apart
Receives: Other: Platelet Rich Plasma Injection; Other: Saline Injection
Saline InjectionActive comparator2 Saline Injections 2 months apart
Receives: Other: Saline Injection

What is being measured

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

  1. Pain

    VAS Score

    Measured: 6 months

  2. Function

    DASH Score

    Measured: 6 months

Timeline

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

  1. First posted22 Jan 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion20 Sep 2016
  4. Study completion20 Sep 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343822
Sponsor's protocol ID
CN-14-2117-B
Acronym
PRPLE
Status last verified
Jun 2018
First submitted
16 Jan 2015
Last updated
18 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16400654

  • 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.

    PubMed 22972856

  • 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

  • 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.

    PubMed 23825183

  • 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.

    PubMed 20448192

  • 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.

    PubMed 21422467

  • 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

  • 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.

    PubMed 937623

  • 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.

    PubMed 21562414

Questions about this trial

What is this clinical trial studying?

A study testing Platelet Rich Plasma Injection and Saline Injection in people with Tennis Elbow and Lateral Epicondylitis, run by Kaiser Permanente at 1 site in United States.

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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Jun 2018. 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 United States. 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.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Pain (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02343822, which also lists 9 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 18 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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