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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04576195
Enrollment
60
Registered
2020-10-06
Start date
2020-10-09
Completion date
2023-03-21
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tennis Elbow

Keywords

Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve Stimulation

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.

Interventions

OTHERReal 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.

OTHERSham 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

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Pressure pain threshold using an algometerBaseline 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

MeasureTime frameDescription
Changes in Pain Intensity: Visual Analogue ScaleBaseline 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 StrengthBaseline 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 periodsTime Frame: Baseline,10 minutes post-interventionGlobal 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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026