US-guided Percutaneous needle tenotomy and Physiotherapy in Patients with Lateral Epicondalgia: A single blinded Randomized Controlled Trial

Lateral epicondylalgia of the elbow is a common cause for chronic pain in the
elbow, where the pain is present for longer than 6 months. 1,2 Currently, the
rationale is that the epicondylalgia is the result of the respective strain of
the hand, wrist and elbow. But it can also be initiated by an acute trauma. In
some cases the symptoms of the epicondylalgia can be difficult to treat with
resulting persistent pain and restrictions in activities in daily life.

Multiple treatment methods for lateral epicondylalgia are described in the
literature. 2-8 These methods can be categorized in conservative, minimal
invasive and operative treatments. Conservative treatment is often long-term
physiotherapy ranging from ten to eighteen months. 3,4 In 90% of the cases
conservative treatment is successful. But it is unclear what the best treatment
modality is in the 10% where a lateral epicondylalgia persists and the
previous treatment was without result. There is no current consensus on the
treatment that should be considered as standard in these cases.

Previous studies have shown that percutaneaous needle tenotomy (PNT) may be an
effective minimal invasive method for the treatment of lateral epicondylalgia.
9-11 For this method multiple micro trauma administered in the effected tissue
using a needle. The rationale for this is that the subsequent inflammation
results in a decrease of the symptoms. PNT can be performed under local
anesthetics and is often performed using corticosteroids. However, it has been
show that this addition does not lead to better results. 9

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. Our goal is therefore to study in an RCT
with appropriate power if PNT, together with structured physiotherapy, is an
effective treatment for lateral epicondylalgia.

(see protocol for references)

Primary Objective: To study the effect of PNT and structured physiotherapy on
function and pain of patients with lateral epicondylalgia.
Secondary Objectives: To study the effect of PNT and structured physiotherapy
on quality of life, patient satisfaction, force of hand and fingers and range
of motion of wrist and elbow

A randomized controlled trial with two study groups: 1. PNT and structured
physio-therapy, and 2. structured physiotherapy only.
Measurements will be performed up to one year, with PNT therapy and checkup
visits and taking place in the Sint Maartenskliniek, Ubbergen.

Percutaneous needle tenotomy and physiotherapy

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. The
questionnaires and physical examinations of the upper extremity do not bring
any extra burden.