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Completed

NCT Number: NCT03433716

Neuromodulation in Lateral Elbow Pain

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blanca de La Cruz Torres

Seville, 41010, Spain

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ultrasound-guided percutaneous neuromodulation

Other

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

Primary outcomes

  1. average pain at palpation

    Time frame: Baseline and up to 1 month

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

Secondary outcomes

  1. Patient-Rated Tennis Elbow Evaluation (PRTEE)

    Time frame: Baseline and up to 1 month

    Pain and functional ability

  2. radial nerve cross-sectional area (CSA)

    Time frame: Baseline and up to 1 month

    Cross-sectional area was measure at 4cm proximal to the tip of the lateral epicondyle of humerus

  3. Strengt-Duration (SD) curves

    Time frame: Baseline and up to 1 month

    chronaxie and accommodation index

Sponsors and collaborators

Lead sponsor

Blanca de la Cruz Torres

Other

Registry information

Official study title

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

Acronym: PNM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2018
Registry last updated
Feb 24, 2021

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

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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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