Clinical trial NCT03433716: Neuromodulation in Lateral Elbow Pain
Official title: Ultrasound-guided Percutaneous Neuromodulation in Patients With Lateral Epicondylalgia: a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Percutaneous Neuromodulation, radial nerve, pain
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lateral epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or around the lateral epicondyle of the humerus and common extensor tendon (CET) that is aggravated by dorsiflexion and/or supination of the wrist against resistance. Lateral epicondylitis is one of the most common injuries of the elbow, affecting 1-3% of the population.

Therefore, determining an effective intervention that helps manage the condition and lessens the financial burden is important. Passive physical modalities, including electrotherapy and orthotic devices, are common treatments for the management of elbow pain. Passive physical modalities are physical treatments involving a device that does not require active participation by the patient. In a systematic review, 2017, Dion et al examined the effectiveness of passive physical modalities for the treatment of soft tissue injuries of the elbow, but little evidence exists to support or refute their use.

Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the applicacion of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.

The aim of this pilot study was to examine the effects of a percutaneous neuromodulation intervention in patients with unilateral refractory lateral epicondylitis. Findings from this study may provide further evidence for the relevance of neural tissues in determining the elbow pain and may indicate effects of US-guided NMP technique on the rehabilitation and/or prevention of in patients with unilateral refractory LE.


Eligibility criteria: Inclusion Criteria:

* Presence of pain in the elbow region at least for three months
* Flares with activity
* Tenderness at or within 2cm of the lateral humeral epicondyle on resisted extension of the wrist and/or the third finger.

Exclusion Criteria:

* Participants who had constant or radicular pain
* Any previous surgery or acute trauma in the upper extremity.
* Elbow deformity
* Bilateral symptoms
* Clinical or electrophysiological findings referable to peripheral nerve (ulnar and median) disease and

Primary outcomes:
measure: average pain at palpation
timeFrame: Baseline and up to 1 month
Secondary outcomes:
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: Baseline and up to 1 month
measure: radial nerve cross-sectional area (CSA)
timeFrame: Baseline and up to 1 month
measure: Strengt-Duration (SD) curves
timeFrame: Baseline and up to 1 month
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Blanca de La Cruz Torres
Study officials:
affiliation: University of Seville
name: BLANCA DE LA CRUZ, DR
role: PRINCIPAL_INVESTIGATOR
References: