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Chronic TendinopathyNCT01833598

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

A study testing PNT + PRP and PNT alone in people with Chronic Tendinopathy, run by Hospital for Special Surgery, New York at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Tendinopathy
What is being tested?
PNT + PRP and PNT alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
Sep 2012to Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Hospital for Special Surgery

    New York, New York, 10021

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

    New York, New York, 10029

Other trials in United States

About this study

Official title: The Efficacy of Ultrasound Guided 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.

Being tested
PNT + PRP, PNT alone
Keywords
Chronic tendinopathy, platelet rich plasma, tendonitis, percutaneous tendon tenotomy, pain, shoulder, knee, ankle, foot
Medical subject headings
Tendinopathy, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PNT + PRPProcedure or surgery

    Also called percutaneous needle tenotomy with peritendinous platelet-rich plasma injection

    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.

  • PNT aloneProcedure or surgery

    Also called percutaneous needle tenotomy 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.

Study groups in NCT01833598
Study groupRoleWhat they receive
PNT + PRPActive comparatorpercutaneous needle tenotomy with peritendinous platelet-rich plasma injection
Receives: Procedure: PNT + PRP
PNT aloneActive comparatorpercutaneous needle tenotomy alone
Receives: Procedure: PNT alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in pain based on a visual analog score

    Measured: Week 2

  2. Improvement in pain based on a visual analog score

    Measured: Week 4

  3. Improvement in pain based on a visual analog score

    Measured: Week 6

  4. Improvement in pain based on a visual analog score

    Measured: Week 8

  5. Improvement in pain based on a visual analog score

    Measured: Week 12

Secondary outcomes (10)

  1. Activity Level

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

    Measured: Week 2

  2. Activity Level

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

    Measured: Week 4

  3. Activity Level

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

    Measured: Week 6

  4. Activity Level

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

    Measured: Week 8

  5. Activity Level

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

    Measured: Week 12

  6. Complications

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

    Measured: Week 2

  7. Complications

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

    Measured: Weeks 4

  8. Complications

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

    Measured: Weeks 6

  9. Complications

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

    Measured: Weeks 8

  10. Complications

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

    Measured: Weeks 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionJun 2019
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01833598
Sponsor's protocol ID
2015-189
Other IDs
HSS 2015-189
Status last verified
Nov 2020
First submitted
12 Apr 2013
Last updated
23 Dec 2020
Results posted
No
Data monitoring committee
No

Publications

  • Kaux JF, Forthomme B, Goff CL, Crielaard JM, Croisier JL. Current opinions on tendinopathy. J Sports Sci Med. 2011 Jun 1;10(2):238-53.

    PubMed 24149868

  • Scott A, Ashe MC. Common tendinopathies in the upper and lower extremities. Curr Sports Med Rep. 2006 Sep;5(5):233-41. doi: 10.1097/01.csmr.0000306421.85919.9c.

    PubMed 16934204

  • Fredberg U, Stengaard-Pedersen K. Chronic tendinopathy tissue pathology, pain mechanisms, and etiology with a special focus on inflammation. Scand J Med Sci Sports. 2008 Feb;18(1):3-15. doi: 10.1111/j.1600-0838.2007.00746.x.

    PubMed 18294189

  • Struijs PA, Kerkhoffs GM, Assendelft WJ, Van Dijk CN. Conservative treatment of lateral epicondylitis: brace versus physical therapy or a combination of both-a randomized clinical trial. Am J Sports Med. 2004 Mar;32(2):462-9. doi: 10.1177/0095399703258714.

    PubMed 14977675

  • Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.

    PubMed 20970844

  • McShane JM, Shah VN, Nazarian LN. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow: is a corticosteroid necessary? J Ultrasound Med. 2008 Aug;27(8):1137-44. doi: 10.7863/jum.2008.27.8.1137.

    PubMed 18645071

  • McShane JM, Nazarian LN, Harwood MI. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow. J Ultrasound Med. 2006 Oct;25(10):1281-9. doi: 10.7863/jum.2006.25.10.1281.

    PubMed 16998100

  • Housner JA, Jacobson JA, Misko R. Sonographically guided percutaneous needle tenotomy for the treatment of chronic tendinosis. J Ultrasound Med. 2009 Sep;28(9):1187-92. doi: 10.7863/jum.2009.28.9.1187.

    PubMed 19710216

  • Skjong CC, Meininger AK, Ho SS. Tendinopathy treatment: where is the evidence? Clin Sports Med. 2012 Apr;31(2):329-50. doi: 10.1016/j.csm.2011.11.003.

    PubMed 22341021

  • Maffulli N, Longo UG, Denaro V. Novel approaches for the management of tendinopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2604-13. doi: 10.2106/JBJS.I.01744.

    PubMed 21048180

  • Paavola M, Kannus P, Jarvinen TA, Jarvinen TL, Jozsa L, Jarvinen M. Treatment of tendon disorders. Is there a role for corticosteroid injection? Foot Ankle Clin. 2002 Sep;7(3):501-13. doi: 10.1016/s1083-7515(02)00056-6.

    PubMed 12512406

  • Bahr R, Fossan B, Loken S, Engebretsen L. Surgical treatment compared with eccentric training for patellar tendinopathy (Jumper's Knee). A randomized, controlled trial. J Bone Joint Surg Am. 2006 Aug;88(8):1689-98. doi: 10.2106/JBJS.E.01181.

    PubMed 16882889

  • Nguyen RT, Borg-Stein J, McInnis K. Applications of platelet-rich plasma in musculoskeletal and sports medicine: an evidence-based approach. PM R. 2011 Mar;3(3):226-50. doi: 10.1016/j.pmrj.2010.11.007.

    PubMed 21402369

  • Finnoff JT, Fowler SP, Lai JK, Santrach PJ, Willis EA, Sayeed YA, Smith J. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. PM R. 2011 Oct;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015. Epub 2011 Aug 26.

    PubMed 21872551

  • de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.

    PubMed 20068208

Questions about this trial

What is this clinical trial studying?

A study testing PNT + PRP and PNT alone in people with Chronic Tendinopathy, run by Hospital for Special Surgery, New York at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in pain based on a visual analog score (time frame: Week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01833598, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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