PEAK Platelet Rich Plasma Injection Treatment for Chronic Lateral Epicondylosis
NCT ID: NCT03072381
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2017-01-31
2020-10-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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).
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.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
2. chronic (\>3months) unilateral or bilateral common extensor tendon pain
3. clinical exam findings consistent with CLE
4. imaging confirmation of CLE (U/S or MRI)
5. 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
2. history of bleeding disorders, low-platelet counts, other hematologic conditions
3. elbow pain with other possible etiologies (e.g., degenerative joint disease)
4. currently using anticoagulation or immunosuppressive therapy
5. anticoagulant or immunosuppressive therapy within the prior month
6. known allergy to Lidocaine
7. self-reported pregnancy
8. worker's compensation injury
9. pending litigation
10. concurrent opioid use for pain
11. corticosteroid injection within the past 3 months
12. minors
18 Years
65 Years
ALL
Yes
Sponsors
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DePuy Synthes
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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John J. Wilson, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin-Madison School of Medicine & Public Health
Locations
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Wisconsin Institute of Medical Research (WIMR)
Madison, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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A536110
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\ORTHOPEDIC&REHAB\ORTHO
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 3/10/2017
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0086
Identifier Type: -
Identifier Source: org_study_id