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

NCT04576195 | Completed

• 1 other identifier: 19/043 (b)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Tennis Elbow

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (2)

Real PENS

EXPERIMENTAL

One single session of PENS

Other: Real PENS

Sham PENS

SHAM COMPARATOR

One single session of Sham-PENS

Other: Sham PENS

Interventions

Real PENS 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.

Real PENS

Sham PENS 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

Sham PENS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 6, 2020
• Study Start: October 9, 2020
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-01

Locations

ES (1)