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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04576195
Other study ID # 19/043 (b)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 9, 2020
Est. completion date March 21, 2023

Study information

Verified date January 2023
Source Universidad Complutense de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 21, 2023
Est. primary completion date March 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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 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

Locations

Country Name City State
Spain Universidad Complutense de Madrid Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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
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