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

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Completed

CT.gov ID

NCT01833598

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Tendinopathy	Procedure: PNT + PRP Procedure: PNT alone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PNT + PRP percutaneous needle tenotomy with peritendinous platelet-rich plasma injection	Procedure: PNT + PRP 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. Other Names: percutaneous needle tenotomy with peritendinous platelet-rich plasma injection
Active Comparator: PNT alone percutaneous needle tenotomy alone	Procedure: PNT alone 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. Other Names: percutaneous needle tenotomy alone

Arm

Intervention/Treatment

Active Comparator: PNT + PRP

percutaneous needle tenotomy with peritendinous platelet-rich plasma injection

Procedure: PNT + PRP

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.

Other Names:

percutaneous needle tenotomy with peritendinous platelet-rich plasma injection

Active Comparator: PNT alone

percutaneous needle tenotomy alone

Procedure: PNT alone

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.

Other Names:

percutaneous needle tenotomy alone

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021
2	Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029