- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03072381
PEAK Platelet Rich Plasma Injection Treatment for Chronic Lateral Epicondylosis
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53705
- Wisconsin Institute of Medical Research (WIMR)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- self-reported pregnancy
- worker's compensation injury
- pending litigation
- concurrent opioid use for pain
- corticosteroid injection within the past 3 months
- minors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Platelet Rich Plasma - Group 1
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. |
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).
|
Placebo Comparator: Corticosteroid Control - Group 2
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
one year (52 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasound evaluation of changes of pathologic features
Time Frame: one year (52 weeks)
|
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.
|
one year (52 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of subject satisfaction of PRP therapy
Time Frame: one year (52 weeks)
|
Outcome measures will be compared for satisfaction with PRP therapy as assessed by the treatment satisfaction survey score at 52 weeks post-treatment.
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one year (52 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John J. Wilson, MD, MS, University of Wisconsin-Madison School of Medicine & Public Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-0086
- A536110 (Other Identifier: UW Madison)
- SMPH\ORTHOPEDIC&REHAB\ORTHO (Other Identifier: UW Madison)
- Protocol Version 3/10/2017 (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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