Neuromodulation in Lateral Elbow Pain

Study Overview
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Brief Summary
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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.

Official Title
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Ultrasound-guided Percutaneous Neuromodulation in Patients With Lateral Epicondylalgia: a Pilot Randomized Clinical Trial

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Other: Ultrasound-guided Percutaneous Neuromodulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNM group<br>Subjects were treated for 3 weeks, once a week. Specifically, this consisted in the application of a square wave biphasic electrical current, with 10Hz frequency, a 250µs pulse width, and the maximal tolerable intensity to cause an exacerbated muscle contraction for a total of 1.5 mins, according to the protocol by Valera and Minaya. The subjects were seated while their arms were supported by an arm rest, forearms pronated and elbows moderately flexed. The radial nerve was located at 4cm proximal to the tip of the lateral epicondyle of humerus using an ultrasound machine (cross-section), subsequently, an acupuncture needle (0.30mm x 30mm) was inserted in a short axis approach, perpendicular to the surface of the skin, until the perineurium of the radial nerve (in close proximity). | Other: Ultrasound-guided Percutaneous Neuromodulation<br>* It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound<br>|
| No Intervention: Control group<br>the subects of the control group received no any treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average pain at palpation | Numerical rating scale (NRS) (0, points; 10, maximum points). | Baseline and up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Rated Tennis Elbow Evaluation (PRTEE) | Pain and functional ability | Baseline and up to 1 month | 
| radial nerve cross-sectional area (CSA) | Cross-sectional area was measure at 4cm proximal to the tip of the lateral epicondyle of humerus | Baseline and up to 1 month | 
| Strengt-Duration (SD) curves | chronaxie and accommodation index | Baseline and up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Neuromodulation, radial nerve, pain