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

NCT ID: NCT04576195

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-09
• Study Completion Date: 2023-03-21

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.

Conditions

Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Real PENS

One single session of PENS

Group Type: EXPERIMENTAL

Real PENS

Intervention Type: OTHER

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

One single session of Sham-PENS

Group Type: SHAM_COMPARATOR

Sham PENS

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

19/043 (b)

Identifier Type: -

Identifier Source: org_study_id