Platelet-Rich Plasma Therapy for Patellar Tendinopathy

Patellar Tendinitis Clinical Trial

— PRP  

Official title:

Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136965
• Other study ID #: 2016-0811
• Secondary ID: A539300SMPH/RADI
• Status: Completed
• Phase: Phase 2
• Start date: April 25, 2017
• Est. completion date: August 15, 2022

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.

Description:

Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 39 years

2. Chronic (>3 months) PT

3. Clinical examination consistent with PT

4. MRI or US confirmation of PT

5. Pain score of 3 or greater on a 10-point visual analogue scale

6. Self-report failure of supervised physical therapy

7. Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).

Exclusion Criteria:

1. Inability to comply with study follow-up requirements

2. History of bleeding disorders or other hematologic conditions

3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)

4. Full or partial patellar tendon tear

5. Current use of anticoagulation or immunosuppressive therapy

6. Prior knee trauma requiring medical attention or surgery

7. Worker's compensation injury

8. Daily opioid use for pain

9. Contraindication to MRI.

10. Systemic diseases such as Diabetes and connective tissue diseases.

11. Prior PRP or DN procedure.

12. Women that are pregnant

Related Conditions & MeSH terms

• Patellar Tendinitis
• Tendinopathy

Intervention

Biological:
• PRP
Injection of autologous platelet rich plasma (PRP)

Procedure:
• Dry Needling
This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
• Dry Needling - Sham
This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	General Electric

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention	Flexor and extensor muscle strength will be measured with this device before and after the intervention.	baseline, 16 weeks, 52 weeks
Other	Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment.	To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.	52 weeks
Other	Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single)	Exploratory MRI measure	baseline, 16 weeks, 52 weeks
Other	T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF)		baseline, 16 weeks, 52 weeks
Primary	Change in Measure of Pain Level: VISA-P Score	A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.	baseline, 16 weeks, 32 weeks, 52 weeks
Primary	Change in Measure of Activity Level: Tegner Activity Level Score	The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.	baseline, 16 weeks, 32 weeks, 52 weeks
Primary	Change in Visual Analogue Scale (VAS) Pain Score	Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).	baseline, 16 weeks, 32 weeks, 52 weeks
Secondary	MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)	To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.	baseline, 16 weeks, 52 weeks
Secondary	MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)	To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.	baseline, 16 weeks, 52 weeks
Secondary	Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)	To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.	baseline, 16 weeks, 52 weeks
Secondary	Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline	To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Echogenicity is the grey scale images found on standard B-mode exams. The grey scale can change with pathology, therefore, the grading scale is implemented. The data reported are scores from a grading system, where 0 - normal; 1- mild; 2- moderate; 3- severe.	baseline, 16 weeks, 52 weeks
Secondary	Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline	To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Hyperemia means an increase in the number of blood vessels, it is scored on a semi-qualitative scale where 0 - normal; 1- mild; 2- moderate; 3- severe. If there's an improvement in hyperemia grading then the score decreases.	baseline, 16 weeks, 52 weeks