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Clinical Trials/NCT04576195
NCT04576195
Completed
Not Applicable

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

Universidad Complutense de Madrid1 site in 1 country60 target enrollmentOctober 9, 2020
ConditionsTennis Elbow

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tennis Elbow
Sponsor
Universidad Complutense de Madrid
Enrollment
60
Locations
1
Primary Endpoint
Changes in Pressure pain threshold using an algometer
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2020
End Date
March 21, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in Pressure pain threshold using an algometer

Time Frame: 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 Outcomes

  • Changes in Pain Intensity: Visual Analogue Scale(Baseline and immediate (10 minutes after intervention))
  • Changes in Pain-Free Grip Strength(Baseline and immediate (10 minutes after intervention))
  • Changes in Self-perceived Improvement between baseline and follow-up periods(Time Frame: Baseline,10 minutes post-intervention)

Study Sites (1)

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