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

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

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

Study Overview

• Status: Completed
• Conditions: Tennis Elbow
• Intervention / Treatment: Other: Real PENS; Other: Sham PENS

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 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gustavo Plaza, PT, PhD; Phone Number: +34 609578380; Email: gusplaza@ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:

  1. pain during palpation of lateral epicondyle
  2. pain on resisted wrist extension
  3. pain on resisted middle finger extension
  4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real PENS; One single session of PENS	Other: Real PENS; 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.
Sham Comparator: Sham PENS; One single session of Sham-PENS	Other: Sham PENS; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Lateral Epicondylitis; Percutaneous Electrical Nerve Stimulation; Lateral Epicondylalgia; Lateral Elbow Tendinopathy; Lateral Elbow Pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 19/043 (b)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No