Neuromodulation in Lateral Elbow Pain

NCT03433716 | Completed DMC

• 1 other identifier: PNM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis

Keywords

Percutaneous Neuromodulation, radial nerve, pain

Outcome Measures

Primary Outcomes (1)

• average pain at palpation

  Numerical rating scale (NRS) (0, points; 10, maximum points).

  Baseline and up to 1 month

Secondary Outcomes (3)

• Patient-Rated Tennis Elbow Evaluation (PRTEE)

  Baseline and up to 1 month

• radial nerve cross-sectional area (CSA)

  Baseline and up to 1 month

• Strengt-Duration (SD) curves

  Baseline and up to 1 month

Study Arms (2)

PNM group

EXPERIMENTAL

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

Control group

NO INTERVENTION

the subects of the control group received no any treatment

Interventions

Ultrasound-guided Percutaneous Neuromodulation OTHER

It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound

PNM group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Blanca de la Cruz Torres: lead

Study Sites (1)

Blanca de La Cruz Torres

Seville, 41010, Spain

Location

MeSH Terms

Conditions

Tennis Elbow; Pain

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• BLANCA DE LA CRUZ, DR

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 15, 2018
• Study Start: May 6, 2018
• Primary Completion: May 6, 2018
• Study Completion: June 15, 2018
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

ES (1)