Neuromodulation in Lateral Elbow Pain (PNM)

Ultrasound-guided Percutaneous Neuromodulation in Patients With Lateral Epicondylalgia: a Pilot Randomized Clinical Trial

Lateral epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or around the lateral epicondyle of the humerus and common extensor tendon (CET) that is aggravated by dorsiflexion and/or supination of the wrist against resistance. Lateral epicondylitis is one of the most common injuries of the elbow, affecting 1-3% of the population.

Therefore, determining an effective intervention that helps manage the condition and lessens the financial burden is important. Passive physical modalities, including electrotherapy and orthotic devices, are common treatments for the management of elbow pain. Passive physical modalities are physical treatments involving a device that does not require active participation by the patient. In a systematic review, 2017, Dion et al examined the effectiveness of passive physical modalities for the treatment of soft tissue injuries of the elbow, but little evidence exists to support or refute their use.

Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the applicacion of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.

The aim of this pilot study was to examine the effects of a percutaneous neuromodulation intervention in patients with unilateral refractory lateral epicondylitis. Findings from this study may provide further evidence for the relevance of neural tissues in determining the elbow pain and may indicate effects of US-guided NMP technique on the rehabilitation and/or prevention of in patients with unilateral refractory LE.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Other: Ultrasound-guided Percutaneous Neuromodulation

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41010
    • Blanca de La Cruz Torres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of pain in the elbow region at least for three months
• Flares with activity
• Tenderness at or within 2cm of the lateral humeral epicondyle on resisted extension of the wrist and/or the third finger.

Exclusion Criteria:

• Participants who had constant or radicular pain
• Any previous surgery or acute trauma in the upper extremity.
• Elbow deformity
• Bilateral symptoms
• Clinical or electrophysiological findings referable to peripheral nerve (ulnar and median) disease and

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PNM group; Subjects were treated for 3 weeks, once a week. Specifically, this consisted in the application of a square wave biphasic electrical current, with 10Hz frequency, a 250µs pulse width, and the maximal tolerable intensity to cause an exacerbated muscle contraction for a total of 1.5 mins, according to the protocol by Valera and Minaya. The subjects were seated while their arms were supported by an arm rest, forearms pronated and elbows moderately flexed. The radial nerve was located at 4cm proximal to the tip of the lateral epicondyle of humerus using an ultrasound machine (cross-section), subsequently, an acupuncture needle (0.30mm x 30mm) was inserted in a short axis approach, perpendicular to the surface of the skin, until the perineurium of the radial nerve (in close proximity).	Other: Ultrasound-guided Percutaneous Neuromodulation; It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
No Intervention: Control group; the subects of the control group received no any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average pain at palpation	Numerical rating scale (NRS) (0, points; 10, maximum points).	Baseline and up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Rated Tennis Elbow Evaluation (PRTEE)	Pain and functional ability	Baseline and up to 1 month
radial nerve cross-sectional area (CSA)	Cross-sectional area was measure at 4cm proximal to the tip of the lateral epicondyle of humerus	Baseline and up to 1 month
Strengt-Duration (SD) curves	chronaxie and accommodation index	Baseline and up to 1 month

Collaborators and Investigators

• Sponsor: Blanca de la Cruz Torres
• Investigators: Principal Investigator: BLANCA DE LA CRUZ, DR, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2018
• Primary Completion (Actual): May 6, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Percutaneous Neuromodulation, radial nerve, pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: PNM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No