Lateral EpicondylitisPRINTNCT03504111
PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)
A study testing Percutaneous Needle Tenotomy and PRP in people with Lateral Epicondylitis and Tendinosis, run by Kaiser Permanente at 1 site in United States.
Trial summary
Chronic tendinopathy is often very difficult to treat and causes many patients who suffer from it to have significant pain and loss of function leading to disability. Ultrasound has been shown to be very effective in aiding in the diagnosis of soft tissue disorders including tendinopathy and can help to rule in or out… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis, Tendinosis, Elbow, Tennis
- What is being tested?
- Percutaneous Needle Tenotomy and PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 31 Dec 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults: 18 years and older
- Diagnosed with: Lateral epicondylitis or common extensor tendinopathy
- Has had symptoms for more than 3 months
- Failed conservative treatment with an eccentric loading protocol that was formally taught and attempted for at least 6 weeks.
- Failed at least 1 corticosteroid injection (anatomically or ultrasound guided injection)
Who cannot join
- Age less than 18 years
- Pregnant or breast feeding females
- Previous surgery to the area of interest
- Previous needling procedure to the area of interest in the last 3 months
- Previous steroid injection to the area of interest in the last 3 months
- Previous PRP or autologous blood or prolotherapy to the area of interest
Show all 13Show fewer
- Patients treated for a Workers Compensation related injury
- Any systemic disease that may play a causative role or delay in healing such as rheumatoid arthritis, lupus, immunodeficiency
- Severe degenerative bone disease or severe vascular disease that may be a confounder
- Diagnosis of concomitant nerve involvement in area of interest:
- Carpal tunnel, radial nerve impingement, cervical radiculopathy in patients with lateral epicondylitis
- Any contraindication to use of lidocaine or injections
- Will record if patient is taking any medications that may alter bleeding or clotting such as aspirin, Plavix, Coumadin, Aggrenox, heparin, lovenox, etc, but this will be a relative contraindication and decision is made by patient and provider after informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRINT Trial (Platelet Rich Injections vs. Needle Tenotomy): Evaluation of Ultrasound Guided Procedures for the Treatment of Chronic Tendinosis
Chronic tendinopathy is often very difficult to treat and causes many patients who suffer from it to have significant pain and loss of function leading to disability. Ultrasound has been shown to be very effective in aiding in the diagnosis of soft tissue disorders including tendinopathy and can help to rule in or out other potential causes that may be confounders. Numerous methods have been tried to treat tendinopathy including rest, NSAIDs, bracing, physical therapy, extracorporal shock wave therapy, anesthetic injections, steroid injections, prolotherapy, nitro patches, surgery and more recently platelet rich plasma, all of which have had conflicting results in the literature. Platelet rich plasma (PRP) is an autologous blood product that contains a high concentration of platelet-derived growth factors that have the potential to enhance healing. In a study by Mishra et al, common extensor tenindosis showed improved pain symptoms (71% vs 55% at 24 weeks) with tenontomy combined with PRP compared to percutaneous needle tenontomy alone. Current studies show conflicting results as to whether PRP improves chronic tendinopathy when compared to steroid injections, and many do not have any control group or comparison group. Percutaneous needle tenotomy is the use of a large gauge needle (18 gauge), which may be performed under ultrasound guidance, to fenestrate repeatedly the area of tendinopathy within a tendon in order to disrupt tendinopathic tissue and to induce bleeding and clot formation with release of growth factors. To date there are no published studies comparing percutaneous needle tenotomy (PNT) alone vs. PRP without concomitant tenotomy. Current literature suggests that needle tenotomy may be superior but no head to head studies are currently found in the literature. Most of the published literature of non-operative treatment of tendinosis does not yield clearly designed trials with clear selection criteria. Current literature also lacks studies with significant number of patients that meet both clinical and ultrasound criteria thus previous studies lack sufficient power. The PRINT TRIAL: may enhance the understanding of a superior treatment if it exists.
Hypothesis: In active adults with chronic tendinopathy who have failed to respond to standard of care treatment, the use of ultrasound guided percutaneous needle tenotomy (PNT) alone is superior to PRP without concomitant tenotomy.
Read the detailed description
The objective of our study is to determine if percutaneous needle tenontomy is superior to platelet rich plasma for the treatment of chronic tendinosis. Diagnosis of tendinosis will be confirmed utilizing ultrasound diagnostic criteria similar to past published studies. The study will be a prospective single blinded study utilizing sham phlebotomy, which currently is not found in the published literature. All interventions will be done ultrasound-guided which no studies in the published literature have done prospectively. The main variables of interest include patient outcomes such as improved function, objective clinical improvement as seen on serial ultrasound surveillance and patient reported utility. Secondary outcomes include: determine patient's ability to return to sport or activity and level of activity able to achieve using validated questionnaires. Lastly, compliance with survival curve data will also be evaluated.
- Conditions
- Lateral Epicondylitis, Tendinosis, Elbow, Tennis, Elbows Tendonitis
- Being tested
- Percutaneous Needle Tenotomy, PRP
- Medical subject headings
- Tennis Elbow, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Needle TenotomyProcedure or surgery
Also called Needle Fenestration
A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided needle tenontomy with be performed at the common extensor tendon at the area of tendinosis. There will be approximately 25 passes through the tendon with an 18 gauge needle. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia
PRPProcedure or surgery
Also called Platelet Rich Plasma
A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided injection of the PRP will be performed at the common extensor tendon at the area of tendinosis. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia to the local skin
| Study group | Role | What they receive |
|---|---|---|
| Needle Tenotomy | Active comparator | 1 group will be assigned to get the standard treatment for chronic tendinopathy, percutaneous needle tenotomy (PNT). It is currently considered a standard treatment option. Ultrasound guided PNT with approximately 25 passes through the tendon and enthesis with approximately an 18 gauge needle with adequate amount of anesthetic (lidocaine) for effective anesthesia. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used Receives: Procedure: Percutaneous Needle Tenotomy |
| Platelet Rich Plasma | Active comparator | 1 group will be assigned to the PRP arm. Investigators will have a trained provider draw the blood, and prepare the PRP according to manufacturer and departmental (KP) protocol. Ultrasound guided injection of this PRP using approximately an 18 gauge needle with a single pass through the tendon into affected area as demonstrated on ultrasound. Adequate amount of anesthetic will be given in a separate syringe with adequate amount of anesthetic (lidocaine) for effective anesthesia. Investigators will keep track of amount and type of anesthetic used. The amount of anesthesia will be the same in both arms of the study Receives: Procedure: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DASH Symptoms Score
Disabilities of the arms, shoulder and hand symptoms questionnaire and score
Measured: Change in symptom score between pre-study and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study startJul 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marissa S. Vasquez, Kaiser Permanente
- Investigators
- Marissa S Vasquez, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504111
- Sponsor's protocol ID
- IRB #11064
- Acronym
- Status last verified
- Mar 2019
- First submitted
- 30 Mar 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abate M, Verna S, Di Gregorio P, Salini V, Schiavone C. Sonographic findings during and after Platelet Rich Plasma injections in tendons. Muscles Ligaments Tendons J. 2014 May 8;4(1):29-34. eCollection 2014 Jan.
PubMed 24932444Finnoff 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 21872551Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
PubMed 16735582Chiavaras MM, Jacobson JA. Ultrasound-guided tendon fenestration. Semin Musculoskelet Radiol. 2013 Feb;17(1):85-90. doi: 10.1055/s-0033-1333942. Epub 2013 Mar 13.
PubMed 23487340Hamilton BH, Best TM. Platelet-enriched plasma and muscle strain injuries: challenges imposed by the burden of proof. Clin J Sport Med. 2011 Jan;21(1):31-6. doi: 10.1097/JSM.0b013e318205a658.
PubMed 21200168Boyer MI, Hastings H 2nd. Lateral tennis elbow: "Is there any science out there?". J Shoulder Elbow Surg. 1999 Sep-Oct;8(5):481-91. doi: 10.1016/s1058-2746(99)90081-2.
PubMed 10543604Paoloni J, De Vos RJ, Hamilton B, Murrell GA, Orchard J. Platelet-rich plasma treatment for ligament and tendon injuries. Clin J Sport Med. 2011 Jan;21(1):37-45. doi: 10.1097/JSM.0b013e31820758c7.
PubMed 21200169Balasubramaniam U, Dissanayake R, Annabell L. Efficacy of platelet-rich plasma injections in pain associated with chronic tendinopathy: A systematic review. Phys Sportsmed. 2015 Jul;43(3):253-61. doi: 10.1080/00913847.2015.1005544. Epub 2015 Jan 20.
PubMed 25599747Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921.
PubMed 19875361Housner 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 19710216McShane 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 18645071Mautner K, Colberg RE, Malanga G, Borg-Stein JP, Harmon KG, Dharamsi AS, Chu S, Homer P. Outcomes after ultrasound-guided platelet-rich plasma injections for chronic tendinopathy: a multicenter, retrospective review. PM R. 2013 Mar;5(3):169-75. doi: 10.1016/j.pmrj.2012.12.010. Epub 2013 Feb 9.
PubMed 23399297Mautner K, Kneer L. Treatment of tendinopathies with platelet-rich plasma. Phys Med Rehabil Clin N Am. 2014 Nov;25(4):865-80. doi: 10.1016/j.pmr.2014.06.008. Epub 2014 Aug 30.
PubMed 25442163Sanchez M, Anitua E, Orive G, Mujika I, Andia I. Platelet-rich therapies in the treatment of orthopaedic sport injuries. Sports Med. 2009;39(5):345-54. doi: 10.2165/00007256-200939050-00002.
PubMed 19402740Sims SE, Miller K, Elfar JC, Hammert WC. Non-surgical treatment of lateral epicondylitis: a systematic review of randomized controlled trials. Hand (N Y). 2014 Dec;9(4):419-46. doi: 10.1007/s11552-014-9642-x.
PubMed 25414603
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRINT Trial (Platelet Rich Injections vs. Needle Tenotomy): Evaluation of Ultrasound Guided Procedures for the Treatment of Chronic Tendinosis
- ClinicalTrials.gov ID
- NCT03504111
- Acronym / sponsor ID
- PRINT / IRB #11064
- Conditions
- Lateral Epicondylitis, Tendinosis, Elbow, Tennis, Elbows Tendonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic tendinopathy is often very difficult to treat and causes many patients who suffer from it to have significant pain and loss of function leading to disability. Ultrasound has been shown to be very effective in aiding in the diagnosis of soft tissue disorders including tendinopathy and can help to rule in or out other potential causes that may be confounders. Numerous methods have been tried to treat tendinopathy including rest, NSAIDs, bracing, physical therapy, extracorporal shock wave therapy, anesthetic injections, steroid injections, prolotherapy, nitro patches, surgery and more recently platelet rich plasma, all of which have had conflicting results in the literature. Platelet rich plasma (PRP) is an autologous blood product that contains a high concentration of platelet-derived growth factors that have the potential to enhance healing. In a study by Mishra et al, common extensor tenindosis showed improved pain symptoms (71% vs 55% at 24 weeks) with tenontomy combined with PRP compared to percutaneous needle tenontomy alone. Current studies show conflicting results as to whether PRP improves chronic tendinopathy when compared to steroid injections, and many do not have any control group or comparison group. Percutaneous needle tenotomy is the use of a large gauge needle (18 gauge), which may be performed under ultrasound guidance, to fenestrate repeatedly the area of tendinopathy within a tendon in order to disrupt tendinopathic tissue and to induce bleeding and clot formation with release of growth factors. To date there are no published studies comparing percutaneous needle tenotomy (PNT) alone vs. PRP without concomitant tenotomy. Current literature suggests that needle tenotomy may be superior but no head to head studies are currently found in the literature. Most of the published literature of non-operative treatment of tendinosis does not yield clearly designed trials with clear selection criteria. Current literature also lacks studies with significant number of patients that meet both clinical and ultrasound criteria thus previous studies lack sufficient power. The PRINT TRIAL: may enhance the understanding of a superior treatment if it exists.
Hypothesis: In active adults with chronic tendinopathy who have failed to respond to standard of care treatment, the use of ultrasound guided percutaneous needle tenotomy (PNT) alone is superior to PRP without concomitant tenotomy.
Detailed description
The objective of our study is to determine if percutaneous needle tenontomy is superior to platelet rich plasma for the treatment of chronic tendinosis. Diagnosis of tendinosis will be confirmed utilizing ultrasound diagnostic criteria similar to past published studies. The study will be a prospective single blinded study utilizing sham phlebotomy, which currently is not found in the published literature. All interventions will be done ultrasound-guided which no studies in the published literature have done prospectively. The main variables of interest include patient outcomes such as improved function, objective clinical improvement as seen on serial ultrasound surveillance and patient reported utility. Secondary outcomes include: determine patient's ability to return to sport or activity and level of activity able to achieve using validated questionnaires. Lastly, compliance with survival curve data will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle Tenotomy | Active comparator | Procedure: Percutaneous Needle Tenotomy1 group will be assigned to get the standard treatment for chronic tendinopathy, percutaneous needle tenotomy (PNT). It is currently considered a standard treatment option. Ultrasound guided PNT with approximately 25 passes through the tendon and enthesis with approximately an 18 gauge needle with adequate amount of anesthetic (lidocaine) for effective anesthesia. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used |
| Platelet Rich Plasma | Active comparator | Procedure: PRP1 group will be assigned to the PRP arm. Investigators will have a trained provider draw the blood, and prepare the PRP according to manufacturer and departmental (KP) protocol. Ultrasound guided injection of this PRP using approximately an 18 gauge needle with a single pass through the tendon into affected area as demonstrated on ultrasound. Adequate amount of anesthetic will be given in a separate syringe with adequate amount of anesthetic (lidocaine) for effective anesthesia. Investigators will keep track of amount and type of anesthetic used. The amount of anesthesia will be the same in both arms of the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults: 18 years and older
- Diagnosed with: Lateral epicondylitis or common extensor tendinopathy
- Has had symptoms for more than 3 months
- Failed conservative treatment with an eccentric loading protocol that was formally taught and attempted for at least 6 weeks.
- Failed at least 1 corticosteroid injection (anatomically or ultrasound guided injection)
Key exclusion criteria (13 listed)
- Age less than 18 years
- Pregnant or breast feeding females
- Previous surgery to the area of interest
- Previous needling procedure to the area of interest in the last 3 months
- Previous steroid injection to the area of interest in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Needle TenotomyAlso: Needle FenestrationA sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided needle tenontomy with be performed at the common extensor tendon at the area of tendinosis. There will be approximately 25 passes through the tendon with an 18 gauge needle. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia | Procedure or surgery | Needle Tenotomy |
| PRPAlso: Platelet Rich PlasmaA sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided injection of the PRP will be performed at the common extensor tendon at the area of tendinosis. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia to the local skin | Procedure or surgery | Platelet Rich Plasma |
Primary outcome
Change in DASH Symptoms Score
Time frame: Change in symptom score between pre-study and 1 year
Disabilities of the arms, shoulder and hand symptoms questionnaire and score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 24932444Abate M, Verna S, Di Gregorio P, Salini V, Schiavone C. Sonographic findings during and after Platelet Rich Plasma injections in tendons. Muscles Ligaments Tendons J. 2014 May 8;4(1):29-34. eCollection 2014 Jan.
- Background: PubMed 21872551Finnoff 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.
- Background: PubMed 16735582Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
- Background: PubMed 23487340Chiavaras MM, Jacobson JA. Ultrasound-guided tendon fenestration. Semin Musculoskelet Radiol. 2013 Feb;17(1):85-90. doi: 10.1055/s-0033-1333942. Epub 2013 Mar 13.
- Background: PubMed 21200168Hamilton BH, Best TM. Platelet-enriched plasma and muscle strain injuries: challenges imposed by the burden of proof. Clin J Sport Med. 2011 Jan;21(1):31-6. doi: 10.1097/JSM.0b013e318205a658.
- Background: PubMed 10543604Boyer MI, Hastings H 2nd. Lateral tennis elbow: "Is there any science out there?". J Shoulder Elbow Surg. 1999 Sep-Oct;8(5):481-91. doi: 10.1016/s1058-2746(99)90081-2.
- Background: PubMed 21200169Paoloni J, De Vos RJ, Hamilton B, Murrell GA, Orchard J. Platelet-rich plasma treatment for ligament and tendon injuries. Clin J Sport Med. 2011 Jan;21(1):37-45. doi: 10.1097/JSM.0b013e31820758c7.
- Background: PubMed 25599747Balasubramaniam U, Dissanayake R, Annabell L. Efficacy of platelet-rich plasma injections in pain associated with chronic tendinopathy: A systematic review. Phys Sportsmed. 2015 Jul;43(3):253-61. doi: 10.1080/00913847.2015.1005544. Epub 2015 Jan 20.
- Background: PubMed 19875361Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921.
- Background: PubMed 19710216Housner 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.
- Background: PubMed 18645071McShane 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.
- Background: PubMed 23399297Mautner K, Colberg RE, Malanga G, Borg-Stein JP, Harmon KG, Dharamsi AS, Chu S, Homer P. Outcomes after ultrasound-guided platelet-rich plasma injections for chronic tendinopathy: a multicenter, retrospective review. PM R. 2013 Mar;5(3):169-75. doi: 10.1016/j.pmrj.2012.12.010. Epub 2013 Feb 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa S Vasquez, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Needle Tenotomy and PRP in people with Lateral Epicondylitis and Tendinosis, run by Kaiser Permanente at 1 site 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Change in DASH Symptoms Score (time frame: Change in symptom score between pre-study and 1 year). 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 NCT03504111, which also lists 16 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 13 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.