Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia

Study Overview
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Brief Summary
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Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. Several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation has shown reduce pain in several conditions. Percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia. Hypothesis: Percutaneous electrical stimulation on radial nerve plus in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation

Detailed Description
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Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve. Study Aims: Aim #1: The primary aim of the study is to compare the immediate effect of a single session of PENS on pressure pain sensitivity as measured by pressure pain threshold in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS Aim #2: The secondary aim of the study is to compare the immediate effect on pain free grip strength, on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS.

Official Title
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Immediate Neurophysiological Effects of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

Conditions
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Tennis Elbow

Intervention / Treatment
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* Other: Real PENS
* Other: Sham PENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test: pain during palpation of lateral epicondyle pain on resisted wrist extension pain on resisted middle finger extension pain during hand-grip Exclusion Criteria: History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb. Neurological disorders, inflammatory and/or degenerative diseases. Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before. Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy. Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases). Contraindications of electrical current application

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real PENS<br>One single session of PENS | Other: Real PENS<br>* The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following: Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current: TENS Frequency 2 Hz TENS Pulse width - 250 microseconds Duration - 30 minutes. TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity. Administration - One single session.<br>|
| Sham Comparator: Sham PENS<br>One single session of Sham-PENS | Other: Sham PENS<br>* The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following: Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's The electrical current will not be working, and the needles will be placed during 30 minutes: - Administration - One single session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pressure pain threshold using an algometer | Measurement of pressure pain threshold in the lateral epicondyle, radial nerve in the spiral groove, C5-C6 zygapophyseal joints, and the tibialis anterior muscle. | Baseline and immediate (10 minutes after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Intensity: Visual Analogue Scale | Pain intensity measured with a 100 mm (0 - No pain - 100 The worst pain) visual analogue scale | Baseline and immediate (10 minutes after intervention) | 
| Changes in Pain-Free Grip Strength | Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer | Baseline and immediate (10 minutes after intervention) | 
| Changes in Self-perceived Improvement between baseline and follow-up periods | Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover) | Time Frame: Baseline,10 minutes post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve Stimulation