PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/15/2019 |
| Start Date: | July 2016 |
| End Date: | December 31, 2019 |
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.
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.
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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.
We found this trial at
1
site
Los Angeles, California 90027
Principal Investigator: Marissa S Vasquez, MD
Phone: 323-783-5814
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