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EpicondylitisPhase 3B-PRPtendonNCT01945528

Platelet Rich Plasma (PRP) in Chronic Epicondylitis

A Phase 3 study testing US-guided tenotomy with PRP and US-guided tenotomy with lidocaine in people with Epicondylitis, run by Jose Ignacio Martin at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but its efficacy remains controversial. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Epicondylitis
What is being tested?
US-guided tenotomy with PRP and US-guided tenotomy with lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
2 sitesSpain
Study dates
Apr 2014to 1 Jul 2018
Phase
Phase 3
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Tendinopathy present in either lateral or medial elbow
  • Pain by palpation at the lateral or medial epicondyle of the elbow
  • Baseline elbow pain >3/10 during resisted wrist extension
  • History of at least two periods of elbow pain lasting more than 10 days
  • Symptoms lasting at least 3 months or longer
  • Body Mass Index between 20 and 35.
  • Commitment to comply with all study procedures
  • The patient must give written informed consent

Who cannot join

  • Presence of full tendon tear
  • Body mass index> 35
  • Systemic autoimmune rheumatologic disease (connective tissue diseases and systemic necrotizing vasculitis)
  • Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
  • Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9)
  • Patients receiving immunosuppressive treatments
Show all 12Show fewer
  • Received local steroid injection within 3 months of randomization received nonsteroidal antiinflammatory, opioids or oral corticosteroids within 15 days before inclusion in the study
  • Severe heart diseasePatients unable to comply with scheduled visits, for work or spend long periods away from their habitual residence.
  • Patients with active cancer or cancer diagnosed in the last five years.
  • Analytical Diagnosis Hepatitis B, C or HIV infection.
  • Pregnant or lactating.
  • People who are taking a drug in clinical investigation or participated in any investigational study clinic (with an authorized or not) within 30 days prior to randomization.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Cruces University Hospital/BioCruces Health Research Institute

    Barakaldo, Bizkaia, 48903

  • Cruces University Hospital

    Barakaldo, Bizkaia, 48903

Other trials in Spain

About this study

Official title: Pilot Randomized Controlled Trial to Evaluate Safety and Efficacy of Percutaneous Needle Tenotomy With Platelet Rich Plasma (Leukocyte Depleted)in Epicondylitis

Background Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but its efficacy remains controversial. Current experimental research postulates different efficiency among PRP formulations.Recent reviews showed that most clinical studies in tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy of pure-PRP in the management of epicondylitis.

The investigators hypothesized that pure PRP associated to needling intervention can enhance tendon healing in epicondylitis, improve function and reduce pain.

Read more

Methods and design Randomized double blind controlled trial, a total of 80 patients will be randomly allocated into one of two groups: PRP or control. Interventions: PRP group, ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate week for a total of two interventions. Control Group: US-guided needling with lidocaine each alternate week for a total of two interventions. Main outcome measure: Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome measure score, before and six months after intervention.The primary end-point is 25% reduction in DASH. The investigators will compare the percentage of patients, in each group, that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.

Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up. Changes in sonographic features and neovascularity at 3, 6 and 12 months.

Conditions
Epicondylitis
Being tested
US-guided tenotomy with PRP, US-guided tenotomy with lidocaine
Keywords
Platelet Rich Plasma, tendinopathy, epicondylitis, ultrasound, injection therapy, needle tenotomy
Medical subject headings
Tendinopathy

What participants receive

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

  • US-guided tenotomy with PRPDrug

    Also called pure-PRP (without leukocytes)

    Blood will be drawn from the patient from the patient's unaffected arm. the anti-coagulated blood will be centrifuged and pure-PRP (without leukocytes) collected.

    Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; PRP will be delivered in multiple depots during the procedure

  • US-guided tenotomy with lidocaineDrug

    Also called local anesthetic

    Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure

Study groups in NCT01945528
Study groupRoleWhat they receive
US-guided tenotomy with PRPExperimentalultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions
Receives: Drug: US-guided tenotomy with PRP
US-guided tenotomy with lidocaineActive comparatorultrasound-guided percutaneous needle tenotomy with lidocaine injection each alternate week for a total of two interventions
Receives: Drug: US-guided tenotomy with lidocaine

What is being measured

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

  1. changes in the DASH-E score

    percentage of patients that achieve a successful treatment defined as a reduction of at least 25% in the DASH score compared with baseline

    Measured: six months

Secondary outcomes (4)

  1. Percentage of patients that achieve a successful treatment

    successful treatment defined as a reduction of greater than 25% of the DASH-E score

    Measured: three and twelve months

  2. Pain reduction as measured by VAS.

    changes in pain rating on a visual analogue scale (VAS)with respect to baseline

    Measured: three, six and twelve months

  3. changes in echogenicity and vascularity as assessed by Doppler sonography

    Measured: three, six and twelve months

  4. frequency, severity, intensity and duration of adverse events

    Measured: three, six and twelve months

Timeline

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

  1. First posted18 Sep 2013 (estimated)
  2. Study startApr 2014
  3. Primary completion1 Jul 2018
  4. Study completion1 Jul 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01945528
Sponsor's protocol ID
2013-000478-32
Other IDs
2013-000478-32
Acronym
B-PRPtendon
Status last verified
Jan 2019
First submitted
16 Sep 2013
Last updated
16 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • Andia I, Sanchez M, Maffulli N. Tendon healing and platelet-rich plasma therapies. Expert Opin Biol Ther. 2010 Oct;10(10):1415-26. doi: 10.1517/14712598.2010.514603.

    PubMed 20718690

  • Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.

    PubMed 34590307

  • Martin JI, Atilano L, Merino J, Gonzalez I, Iglesias G, Areizaga L, Bully P, Grandes G, Andia I. Platelet-rich plasma versus lidocaine as tenotomy adjuvants in people with elbow epicondylopathy: a randomized controlled trial. J Orthop Surg Res. 2019 Apr 23;14(1):109. doi: 10.1186/s13018-019-1153-6.

    PubMed 31014382

  • Martin JI, Atilano L, Merino J, Gonzalez I, Iglesias G, Areizaga L, Bully P, Grandes G, Andia I. Predictors of Outcome Following Tenotomy in Patients with Recalcitrant Epicondylopathy. PM R. 2019 Sep;11(9):979-988. doi: 10.1002/pmrj.12064. Epub 2019 Mar 19.

    PubMed 30609276

  • Martin JI, Merino J, Atilano L, Areizaga LM, Gomez-Fernandez MC, Burgos-Alonso N, Andia I. Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial. Trials. 2013 Dec 1;14:410. doi: 10.1186/1745-6215-14-410.

    PubMed 24289799

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing US-guided tenotomy with PRP and US-guided tenotomy with lidocaine in people with Epicondylitis, run by Jose Ignacio Martin at 2 sites in Spain.

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 8 inclusion and 12 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: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

changes in the DASH-E score (time frame: six months). 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 NCT01945528, which also lists 5 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 16 Jan 2019.

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