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

NCT01833598 | Completed

• 2 other identifiers: 2015-189HSS 2015-189
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Tendinopathy

Keywords

Chronic tendinopathy; platelet rich plasma; tendonitis; percutaneous tendon tenotomy; pain; shoulder; knee; ankle; foot

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Activity Level

  Week 2

• Activity Level

  Week 4

• Activity Level

  Week 6

• Activity Level

  Week 8

• Activity Level

  Week 12

Study Arms (2)

PNT + PRP

ACTIVE COMPARATOR

percutaneous needle tenotomy with peritendinous platelet-rich plasma injection

Procedure: PNT + PRP

PNT alone

ACTIVE COMPARATOR

percutaneous needle tenotomy alone

Procedure: PNT alone

Interventions

PNT + PRP PROCEDURE

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.

Also known as: percutaneous needle tenotomy with peritendinous platelet-rich plasma injection

PNT + PRP

PNT alone PROCEDURE

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.

Also known as: percutaneous needle tenotomy alone

PNT alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (2)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (25)

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  PMID: 33644963 DERIVED

MeSH Terms

Conditions

Tendinopathy; Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Jonathan Kirschner, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 17, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 23, 2020

Record last verified: 2020-11

Locations

US (2)