Clinical trial NCT04576195: Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia
Official title: Immediate Neurophysiological Effects of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Keywords: Lateral Epicondylalgia
Lateral Epicondylitis
Lateral Elbow Tendinopathy
Lateral Elbow Pain
Percutaneous Electrical Nerve Stimulation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Pressure pain threshold using an algometer
timeFrame: Baseline and immediate (10 minutes after intervention)
Secondary outcomes:
measure: Changes in Pain Intensity: Visual Analogue Scale
timeFrame: Baseline and immediate (10 minutes after intervention)
measure: Changes in Pain-Free Grip Strength
timeFrame: Baseline and immediate (10 minutes after intervention)
measure: Changes in Self-perceived Improvement between baseline and follow-up periods
timeFrame: Time Frame: Baseline,10 minutes post-intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References: