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NCT Number: NCT04442321

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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 short, mid and long-term of PENS on intensity of pain as measured by numeric pain rating scale and disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) 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 short, medium and long-term of PENS on disability as measured by DASH questionnaire, and psychological factors (fear and avoidance and catastrophism) and Global Rating of Change (GRoC) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in Elbow Pain Intensity between baseline and follow-up periods

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

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

Secondary outcomes

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

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

    Measured with Patient Rated Tennis Elbow Evaluation (PRTEE). It is a 15-item questionnaire designed to measure forearm pain and disability in patients

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

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

    Measured with Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. It includes 30 items assessing (1) degree of difficulty during the preceding week in performing several physical activities because of problems in a upper extremity (21 items), (2) severity of each of the symptoms of pain, activity related pain, tingling, weakness, and stiffness (5 items), and (3) the problem's effect on social activities, work, and sleep and its psychological impact (4 items). Each item is answered on a 5-point scale ranging from 1 (no difficulty to perform, no symptom, or no impact) to 5 (unable to do, very severe symptom, or high impact). The responses to the 30 items are summed to form a raw score that is then converted to a scale from 0 to 100 with a formula. A higher score reflects greater disability.

  3. Changes in Kinesiophobia between baseline and follow-up periods

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

    Tampa Scale for Kinesiophobia. To assess the fear of movement and pain-related fear. The 11 items are scored 1-4, with total scores ranging from 11 to 44. The addition of all the points obtained from each of the items results in the level of kinesiophobia, with higher scores indicating greater perceived kinesiophobia

  4. Changes in Pain Catastrophizing between baseline and follow-up periods

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

    Pain Catastrophizing Scale (PCS). This tool is a 13-item questionnaire designed to measure the three components of pain-related catastrophizing: rumination, magnification, and helplessness, resulting in a unique score. Each item is responded to on a 5-point scale (0 not at all, 4 all the time) relating the degree to which the individual experiences a thought or feeling of a painful situation.

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

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

    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)

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 22, 2020
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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