The effect of US-guided percutaneous needle tenotomy and physiotherapy in lateral elbow tendinopathy (tennis elbow)

Rationale: Lateral Elbow Tendinopathy (LET) is a common cause for chronic pain in the elbow, where
the pain is present for longer than 6 months. Multiple treatment methods for LET are described in
the literature. In 90% of the cases conservative treatment is successful. It is however unclear what
the best treatment modality is in the 10% where a LET persists and was unresponsive to the previous
treatment. There is no current consensus on the treatment that should be considered as standard in
these cases. Previous studies have shown that percutaneous needle tenotomy (PNT) may be an
effective minimal invasive method for the treatment of LET. To date, studies on PNT have only been
performed in cohort design or with low numbers. In the Sint Maartenskliniek PNT is used on
indication, but thus without proper scientific support.


Objective: To study the effect of PNT on function and pain of patients with LET.


Study design: A multicenter randomized controlled trial with three study groups: 1. PNT and
structured physiotherapy, 2. local anesthetics (LA) and structured physiotherapy and 3. structured
physiotherapy only.


Study population: Subjects with LET will be selected at the orthopaedic outpatient clinic in our
hospital by the orthopaedic surgeon. The patient information will be provided to the patients who
are referred to the radiologist for possible PNT or LA.


Intervention: PNT is a method where multiple microtrauma are administered in the affected tissue
using a needle following LA. Hence, LA might have an effect due to hydrodissection. The injection of
the anesthetic bolus between surface of the tendon and fat plane can have a beneficial effect on the
neovessels and nerves through mechanical action, in combination with neurotoxicity and
vasoconstriction.


Main study parameters/endpoints: The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a patient
reported outcome measure (PROM) specifically developed for LET. The endpoint of the PRTEE is set
at 3 months post treatment.


Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: PNT is already a treatment option for these patients in our hospital. The patients
included in the study will be seen at pre-intervention and at 3 months. At 3 months post-
intervention the patients will be asked to complete the questionnaires and return them to the clinic.
The extra time investment for the patients is 0.5 x 2 = 1 hour. Patients participating in this study will
not being barred by any additional benefits or risks other than the regular risks for the treatment
with PNT and LA. The questionnaires and physical examinations of the upper extremity do not bring
any extra burden.

Baseline and 3 months post treatment

- Percutaneous needle treatment

- Local anaesthesia

- Physiotherapy