Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

NCT ID: NCT03856125

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-05-21

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 exercise therapy in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation plus exercise.

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 effect of the immediate, short, medium and long-term of PENS on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program.

Aim #2: The secondary aim of the study is to compare the effect of the immediate, short, medium and long-term of PENS on pain free grip strength, disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) and DASH questionnaire and pressure pain threshold (PPT) and area and distribution of pain in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program, and determine if psychological factors (fear and avoidance and catastrophism) change with any of the treatments and if is related with the primary and secondary outcomes.

Conditions

Lateral Epicondylitis

Study Design

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

Study Groups

PENS plus exercise group

4-week intervention program with 2 weekly treatment sessions, one of percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise.

Group Type: EXPERIMENTAL

PENS plus exercise

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 Froshe'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 per week

Sham PENS plus exercise group

4-week intervention program with 2 weekly treatment sessions, one of sham percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise.

Group Type: SHAM_COMPARATOR

Sham PENS plus exercise

Intervention Type: OTHER

The technique will be performed on the radial nerve, the places of the needle's. 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 wil be placed at the at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe's.

The current will not be working, and the needles will be placed during 30 minutes.

• Administration - One per week

Interventions

PENS plus exercise

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 Froshe'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 per week

Intervention Type: OTHER

Sham PENS plus exercise

The technique will be performed on the radial nerve, the places of the needle's. 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 wil be placed at the at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe's.

The current will not be working, and the needles will be placed during 30 minutes.

• Administration - One per week

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
• 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

CI: 19/043

Identifier Type: -

Identifier Source: org_study_id