Chronic Lateral EpicondylosisPhase 2NCT03072381
PEAK Platelet Rich Plasma Injection Treatment for Chronic Lateral Epicondylosis
A Phase 2 study testing Platelet Rich Plasma - Group 1 in people with Chronic Lateral Epicondylosis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The proposed project will be the first to assess pain- and function-dependent, elbow-specific quality of life and in-vivo mechanical properties of common extensor tendons post-treatment with PRP in a Level 1, RCT with subject and assessor blinding. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lateral Epicondylosis
- What is being tested?
- Platelet Rich Plasma - Group 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 28 Oct 2020
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65
- chronic (>3months) unilateral or bilateral common extensor tendon pain
- clinical exam findings consistent with CLE
- imaging confirmation of CLE (U/S or MRI)
- self-reported failure of supervised physical therapy; 6) self-reported failure of at least 2 of the most common treatments (NSAIDs, relative rest, ice, bracing) for CLE.
Who cannot join
- inability to comply with follow-up requirements of study
- history of bleeding disorders, low-platelet counts, other hematologic conditions
- elbow pain with other possible etiologies (e.g., degenerative joint disease)
- currently using anticoagulation or immunosuppressive therapy
- anticoagulant or immunosuppressive therapy within the prior month
- known allergy to Lidocaine
Show all 12Show fewer
- self-reported pregnancy
- worker's compensation injury
- pending litigation
- concurrent opioid use for pain
- corticosteroid injection within the past 3 months
- minors
Trial locations and contacts
1 site in 1 country.
United States1 site
Wisconsin Institute of Medical Research (WIMR)
Madison, Wisconsin, 53705
About this study
Official title: The Clinical, Biomechanical, and Tissue Regenerating Effects of a Single PEAK Platelet Rich Plasma Injection for the Treatment of Chronic Lateral Epicondylosis: a Randomized Controlled Trial
The proposed project will be the first to assess pain- and function-dependent, elbow-specific quality of life and in-vivo mechanical properties of common extensor tendons post-treatment with PRP in a Level 1, RCT with subject and assessor blinding. The valuable data gained will significantly add to the knowledge base of treatment effects of PRP for a chronic tendinopathy. Positive findings of PRP compared to control (corticosteroid injection) would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of CLE. Correlating US and shear wave acoustoelastography imaging assessments with validated clinical outcomes will provide a powerful tool for future outcomes analyses using a non-invasive imaging modality to monitor tissue healing both morphologically as well as biomechanically, and may even be used to evaluate injury risk.
Read the detailed description
Randomization procedures Subjects will be randomized to 1 of 2 study arms. Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline). Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0. If a subject has bilateral elbow common extensor tendon pain, both elbows will be treated in the same study arm.
Blinding: Subjects and assessors will be blinded to the subject group allocation. Control subjects will also undergo phlebotomy to maintain blinding. Injection syringes will be cloaked using opaque adhesive tape in order to ensure the injector is unaware of subject treatment allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched and evaluated in a randomized manner.
Ultrasound imaging analyses will be conducted at baseline, 26 weeks, and 52 weeks post treatment.
The platelet concentration will be analyzed in both samples (whole blood compared to PRP) in order to record and verify the consistency of the concentration factor in PRP.
Shear wave ultrasound imaging will be compared using comparison of average shear wave speed (SWS) between baseline and post treatment 52 week follow-up between the two randomized groups. Shear wave speed is a quantitative measure obtained by measuring speed of ultrasound in a selected region of interest (ROI). In prior studies, the study team has successfully blinded the investigator when selecting the ROI, and conducted inter-rater repeatability analysis showing that this was a valid, repeatable way of measuring SWS in a particular ROI.
For patients:Total of 9 visits Initial Screen - Initial Eligibility Screening Baseline - Informational Meeting: Secondary eligibility screen, enrollment (informed consent), questionnaires; Grip Strength Test; Ultrasound and SWAE imaging Week 0 Intervention - Injection of PRP under ultrasound Weeks 4, 8, 12, 16 - Questionnaires: QUICK-DASH, SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test Week 26 - Questionnaires: QUICK-DASH, SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test; Ultrasound and SWAE imaging Week 52 - Questionnaires: QUICK-DASH, SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test; Ultrasound and SWAE imaging
- Conditions
- Chronic Lateral Epicondylosis
- Being tested
- Platelet Rich Plasma - Group 1, Corticosteroid Control - Group 2
- Keywords
- CLE, epicondylosis, platelet rich plasma, PRP, ultrasound, shear wave ultrasound, tendinopathy, elbow, tenis elbow, plasma, plasma injection, tendinosis, tendinitis
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma - Group 1Biological
Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline).
Corticosteroid Control - Group 2Drug
Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma - Group 1 | Active comparator | Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline).
If a subject has bilateral elbow common extensor tendon pain, both elbows will be treated in the same study arm. Receives: Biological: Platelet Rich Plasma - Group 1 |
| Corticosteroid Control - Group 2 | Placebo comparator | Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0.
If a subject has bilateral elbow common extensor tendon pain, both elbows will be treated in the same study arm. Receives: Drug: Corticosteroid Control - Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the QUICK-DASH upper limb disability questionnaire
Patients receiving a single PRP PEAK injection for CLE will report improved Quick-DASH upper limb disability questionnaire from baseline to 52 week follow-up compared to control subjects (corticosteroid group)
Measured: one year (52 weeks)
Secondary outcomes (1)
Ultrasound evaluation of changes of pathologic features
Improved ultrasound (US) changes of several pathologic features of CLE as evaluated using US imaging of the common extensor tendon from baseline to 52 weeks post-treatment compared to control subjects. Conventional ultrasound will be done to assess thickness (contralateral comparison), neovascularity, and hypoechogenicity; and Acoustoelastography (AE) will be done to measure stiffness changes of the patellar tendon using standardized 0-3 severity scales compared to control subjects.
Measured: one year (52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startJan 2017
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lateral EpicondylosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor
- Investigators
- John J. Wilson, MD, MS, Principal investigator, University of Wisconsin-Madison School of Medicine & Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072381
- Sponsor's protocol ID
- 2016-0086
- Other IDs
- A536110, SMPH\ORTHOPEDIC&REHAB\ORTHO, Protocol Version 3/10/2017
- Status last verified
- Dec 2020
- First submitted
- 8 Nov 2016
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical, Biomechanical, and Tissue Regenerating Effects of a Single PEAK Platelet Rich Plasma Injection for the Treatment of Chronic Lateral Epicondylosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03072381
- Acronym / sponsor ID
- 2016-0086
- Conditions
- Chronic Lateral Epicondylosis
- Keywords
- CLE, epicondylosis, platelet rich plasma, PRP, ultrasound, shear wave ultrasound, tendinopathy, elbow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- Jan 2017 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project will be the first to assess pain- and function-dependent, elbow-specific quality of life and in-vivo mechanical properties of common extensor tendons post-treatment with PRP in a Level 1, RCT with subject and assessor blinding. The valuable data gained will significantly add to the knowledge base of treatment effects of PRP for a chronic tendinopathy. Positive findings of PRP compared to control (corticosteroid injection) would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of CLE. Correlating US and shear wave acoustoelastography imaging assessments with validated clinical outcomes will provide a powerful tool for future outcomes analyses using a non-invasive imaging modality to monitor tissue healing both morphologically as well as biomechanically, and may even be used to evaluate injury risk.
Detailed description
Randomization procedures Subjects will be randomized to 1 of 2 study arms. Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline). Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0. If a subject has bilateral elbow common extensor tendon pain, both elbows will be treated in the same study arm.
Blinding: Subjects and assessors will be blinded to the subject group allocation. Control subjects will also undergo phlebotomy to maintain blinding. Injection syringes will be cloaked using opaque adhesive tape in order to ensure the injector is unaware of subject treatment allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched and evaluated in a randomized manner.
Ultrasound imaging analyses will be conducted at baseline, 26 weeks, and 52 weeks post treatment.
The platelet concentration will be analyzed in both samples (whole blood compared to PRP) in order to record and verify the consistency of the concentration factor in PRP.
Shear wave ultrasound imaging will be compared using comparison of average shear wave speed (SWS) between baseline and post treatment 52 week follow-up between the two randomized groups. Shear wave speed is a quantitative measure obtained by measuring speed of ultrasound in a selected region of interest (ROI). In prior studies, the study team has successfully blinded the investigator when selecting the ROI, and conducted inter-rater repeatability analysis showing that this was a valid, repeatable way of measuring SWS in a particular ROI.
For patients:Total of 9 visits Initial Screen - Initial Eligibility Screening Baseline - Informational Meeting: Secondary eligibility screen, enrollment (informed consent), questionnaires; Grip Strength Test; Ultrasound and SWAE imaging Week 0 Intervention - Injection of PRP under ultrasound Weeks 4, 8, 12, 16 - Questionnaires: QUICK-DASH, SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test Week 26 - Questionnaires: QUICK-DASH, SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test; Ultrasound and SWAE imaging Week 52 - Questionnaires: QUICK-DASH, SF-12, PRTEE, SANE-ELBOW, PRP Satisfaction; Grip Strength Test; Ultrasound and SWAE imaging
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma - Group 1 | Active comparator | Biological: Platelet Rich Plasma - Group 1Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline). If a subject has bilateral elbow common extensor tendon pain, both elbows will be treated in the same study arm. |
| Corticosteroid Control - Group 2 | Placebo comparator | Drug: Corticosteroid Control - Group 2Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0. If a subject has bilateral elbow common extensor tendon pain, both elbows will be treated in the same study arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-65
- chronic (>3months) unilateral or bilateral common extensor tendon pain
- clinical exam findings consistent with CLE
- imaging confirmation of CLE (U/S or MRI)
- self-reported failure of supervised physical therapy; 6) self-reported failure of at least 2 of the most common treatments (NSAIDs, relative rest, ice, bracing) for CLE.
Key exclusion criteria (12 listed)
- inability to comply with follow-up requirements of study
- history of bleeding disorders, low-platelet counts, other hematologic conditions
- elbow pain with other possible etiologies (e.g., degenerative joint disease)
- currently using anticoagulation or immunosuppressive therapy
- anticoagulant or immunosuppressive therapy within the prior month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Plasma - Group 1Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline). | Biological | Platelet Rich Plasma - Group 1 |
| Corticosteroid Control - Group 2Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0. | Drug | Corticosteroid Control - Group 2 |
Primary outcome
Change in the QUICK-DASH upper limb disability questionnaire
Time frame: one year (52 weeks)
Patients receiving a single PRP PEAK injection for CLE will report improved Quick-DASH upper limb disability questionnaire from baseline to 52 week follow-up compared to control subjects (corticosteroid group)
1 secondary outcome
Ultrasound evaluation of changes of pathologic features
Time frame: one year (52 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Derived from this study: PubMed 34590307Karjalainen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J. Wilson, MD, MS principal investigator
University of Wisconsin-Madison School of Medicine & Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet Rich Plasma - Group 1 in people with Chronic Lateral Epicondylosis, run by University of Wisconsin, Madison 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 5 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 23 Dec 2020. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in the QUICK-DASH upper limb disability questionnaire (time frame: one year (52 weeks)). 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 NCT03072381, which also lists 1 linked publication.
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 23 Dec 2020.