Neuromodulation in Patients With Unilateral Elbow Pain (PNM)
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|ClinicalTrials.gov Identifier: NCT03433716|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : May 11, 2018
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Lateral Epicondylitis||Other: Ultrasound-guided Percutaneous Neuromodulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ultrasound-guided Percutaneous Neuromodulation in Patients With Unilateral Refractory Lateral Epicondylitis|
|Actual Study Start Date :||May 6, 2018|
|Actual Primary Completion Date :||May 6, 2018|
|Estimated Study Completion Date :||June 1, 2018|
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
- average pain at palpation [ Time Frame: Baseline and up to 1 month ]visual analog scale (VAS) (0, no pain; 10, maximum pain).
- Patient-Rated Tennis Elbow Evaluation (PRTEE) [ Time Frame: Baseline and up to 1 month ]Pain and functional ability
- 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
- Strengt-Duration (SD) curves [ Time Frame: Baseline and up to 1 month ]chronaxia and accommodation index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433716
|Contact: BLANCA DE LA CRUZ, DRfirstname.lastname@example.org|
|Blanca de La Cruz Torres||Recruiting|
|Seville, Spain, 41010|
|Contact: BLANCA DE LA CRUZ, PHD 0034666676870 BCRUZ@US.ES|
|Principal Investigator:||BLANCA DE LA CRUZ, DR||University of Seville|