NCT03856125

Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

Effectiveness of a Combined Treatment Percutaneous Electrical Stimulation on Radial Nerve With an Exercise Program in Patients With Lateral Epicondylalgia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 exercise therapy in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation plus exercise.

Detailed description

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 effect of the immediate, short, medium and long-term of PENS on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program. Aim #2: The secondary aim of the study is to compare the effect of the immediate, short, medium and long-term of PENS on pain free grip strength, disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) and DASH questionnaire and pressure pain threshold (PPT) and area and distribution of pain in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program, and determine if psychological factors (fear and avoidance and catastrophism) change with any of the treatments and if is related with the primary and secondary outcomes.

Conditions

• Lateral Epicondylitis

Interventions

Type	Name	Description
OTHER	PENS plus exercise	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 Froshe'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 per week
OTHER	Sham PENS plus exercise	The technique will be performed on the radial nerve, the places of the needle's. 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 wil be placed at the at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe's. The current will not be working, and the needles will be placed during 30 minutes. \- Administration - One per week

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-05-21
• Completion: 2020-05-21
• First posted: 2019-02-27
• Last updated: 2020-05-26

Locations

1 site across 1 country: Spain