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Completed

NCT Number: NCT01833598

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

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.

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Key information

Conditions

Chronic Tendinopathy Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: percutaneous needle tenotomy with peritendinous platelet-rich plasma injection

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.

Other names: percutaneous needle tenotomy alone

Primary outcomes

  1. Improvement in pain based on a visual analog score

    Time frame: Week 2

  2. Improvement in pain based on a visual analog score

    Time frame: Week 4

  3. Improvement in pain based on a visual analog score

    Time frame: Week 6

  4. Improvement in pain based on a visual analog score

    Time frame: Week 8

  5. Improvement in pain based on a visual analog score

    Time frame: Week 12

Secondary outcomes

  1. Activity Level

    Time frame: Week 2

    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  2. Activity Level

    Time frame: Week 4

    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  3. Activity Level

    Time frame: Week 6

    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  4. Activity Level

    Time frame: Week 8

    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  5. Activity Level

    Time frame: Week 12

    Function, sleep, general well-being, return to normal activities, work, sports and reduction in pain medication usage.

  6. Complications

    Time frame: Week 2

    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  7. Complications

    Time frame: Weeks 4

    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  8. Complications

    Time frame: Weeks 6

    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  9. Complications

    Time frame: Weeks 8

    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

  10. Complications

    Time frame: Weeks 12

    bleeding, infection, tendon rupture, allergic reaction, paralysis, or stroke

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2013
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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