Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis

Study Overview
=================
Brief Summary
-----------------
Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a person's ability to perform daily activities and recreation. Traditional conservative treatments include activity modification, exercises, ice/heat, and medications and corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which the affected area is repetitively needled to disrupt pathological tissue and induce bleeding. This turns a nonhealing chronic injury into an acute injury with enhanced healing capability. Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the affected area, also activating growth factors. There has been promising research in these tendinopathy treatments but more research is needed. The investigators plan to expand on prior studies to identify a reproducible and efficacious treatment for chronic tendinopathy to reduce pain and improve function and quality of life. Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT with peritendinous PRP as a treatment for chronic tendinopathy.

Official Title
-----------------
The Efficacy of Ultrasound Guided Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis

Conditions
-----------------
Chronic Tendinopathy

Intervention / Treatment
-----------------
* Procedure: PNT + PRP
* Procedure: PNT alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-100 years pain (≥ 5/10 pain on the VAS) that is a direct result of tendinosis as determined by history of injury and study team member physician's best judgment and review of medical records, imaging studies, etc. Tendinosis will be confirmed by clinical and ultrasonographic examination by the PI ≥3 months of pain after injury that has failed conservative treatments or after corticosteroid (CSI) (must be 3 months after CSI to avoid theoretical tendon rupture) Exclusion Criteria: taking coumadin or other anti-coagulant or anti-platelet medication known coagulopathy or bleeding dyscrasia current or recent fluoroquinolone prescription prior PNT or PRP for the affected tendon(s) known systemic illness such as vasculitis, an autoimmune or an inflammatory disease, or uncontrolled diabetes presence of other musculoskeletal injury or tendon rupture in the region currently are or plan to become pregnant during the study. Patients taking aspirin or NSAIDs are not excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PNT + PRP<br>percutaneous needle tenotomy with peritendinous platelet-rich plasma injection | Procedure: PNT + PRP<br>* The PNT + PRP group will undergo needle tenotomy under direct and continuous ultrasound guidance with even distribution of PRP into the peritendinous area(s) of PNT around the affected tendon.<br>* Other names: percutaneous needle tenotomy with peritendinous platelet-rich plasma injection;|
| Active Comparator: PNT alone<br>percutaneous needle tenotomy alone | Procedure: PNT alone<br>* The PNT group will undergo needle tenotomy under direct and continuous ultrasound guidance local anesthesia into the affected tendon. 10 minutes after the injection, the ultrasound machine probe will be passed over the areas treated both to evaluate for any structural changes and for any complications.<br>* Other names: percutaneous needle tenotomy alone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pain based on a visual analog score |  | Week 2 | 
| Improvement in pain based on a visual analog score |  | Week 4 | 
| Improvement in pain based on a visual analog score |  | Week 6 | 
| Improvement in pain based on a visual analog score |  | Week 8 | 
| Improvement in pain based on a visual analog score |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 2 | 
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 4 | 
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 6 | 
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 8 | 
| Activity Level | Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage. | Week 12 | 
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Week 2 | 
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 4 | 
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 6 | 
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 8 | 
| Complications | bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke | Weeks 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic tendinopathy, platelet rich plasma, tendonitis, percutaneous tendon tenotomy, pain, shoulder, knee, ankle, foot