Neuromodulation in Lateral Elbow Pain

Lateral Epicondylitis Clinical Trial

— PNM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433716
• Other study ID #: PNM
• Status: Completed
• Phase: N/A
• Start date: May 6, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: February 2021
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 15, 2018
• Est. primary completion date: May 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Other:
• Ultrasound-guided Percutaneous Neuromodulation
It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound

Locations

Country	Name	City	State
Spain	Blanca de La Cruz Torres	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Blanca de la Cruz Torres

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average pain at palpation	Numerical rating scale (NRS) (0, points; 10, maximum points).	Baseline and up to 1 month
Secondary	Patient-Rated Tennis Elbow Evaluation (PRTEE)	Pain and functional ability	Baseline and up to 1 month
Secondary	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
Secondary	Strengt-Duration (SD) curves	chronaxie and accommodation index	Baseline and up to 1 month