Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

NCT04442321 | Completed

• 1 other identifier: 19/043
• 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 exercise therapy in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation plus exercise.

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 Elbow Pain Intensity between baseline and follow-up periods

  Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale

  Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention

Secondary Outcomes (5)

• Changes in Elbow Related-Disability between baseline and follow-up periods

  Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention

• Changes in Upper Extremity Related-Disability between baseline and follow-up period

  Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention

• Changes in Kinesiophobia between baseline and follow-up periods

  Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention

• Changes in Pain Catastrophizing between baseline and follow-up periods

  Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention

• Changes in Self-perceived Improvement between baseline and follow-up periods

  Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention

Study Arms (2)

PENS plus exercise group

ACTIVE COMPARATOR

Experimental: PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently . It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.

Other: PENS plus exercise

Sham PENS plus exercise group

SHAM COMPARATOR

Sham Comparator: Sham PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently. It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.

Other: Sham PENS plus exercise

Interventions

PENS plus exercise 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 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 Self-management loaded exercises prescribed by a physical therapist, two times per week.

PENS plus exercise group

Sham PENS plus exercise 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 The electrical current will not be working, and the needles will be placed during 30 minutes: \- Administration - One per week Self-management loaded exercises prescribed by a physical therapist, two times per week.

Sham PENS plus exercise group

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, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: May 21, 2020
• First Posted: June 22, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 30, 2024
• Last Updated: October 1, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)