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

Not Applicable

Completed

• Conditions: Tennis Elbow
• Interventions: Other: Sham PENS; Other: Real PENS

• Registration Number: NCT04576195
• Lead Sponsor: Universidad Complutense de Madrid

Brief 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 in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation

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 Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-06
• Study Start: 2020-10-09
• Status Verified: 2023-01
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham PENS	Sham PENS	One single session of Sham-PENS
Real PENS	Real PENS	One single session of PENS

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in Pain Intensity: Visual Analogue Scale	Baseline and immediate (10 minutes after intervention)	Pain intensity measured with a 100 mm (0 - No pain - 100 The worst pain) visual analogue scale
Changes in Pain-Free Grip Strength	Baseline and immediate (10 minutes after intervention)	Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer
Changes in Self-perceived Improvement between baseline and follow-up periods	Time Frame: Baseline,10 minutes post-intervention	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)

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain