Neuromodulation in Patients With Unilateral Elbow Pain (PNM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03433716
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : July 27, 2018
Manuel Albornoz Cabello
Information provided by (Responsible Party):
Blanca de la Cruz Torres, University of Seville

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 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)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. average pain at palpation [ Time Frame: Baseline and up to 1 month ]
    visual analog scale (VAS) (0, no pain; 10, maximum pain).

Secondary Outcome Measures :
  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 ]
    chronaxia and accommodation index

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  • A Personal Psychological Apprehension Scale (PPAS) score >37.5 were excluded.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03433716

Blanca de La Cruz Torres
Seville, Spain, 41010
Sponsors and Collaborators
Blanca de la Cruz Torres
Manuel Albornoz Cabello
Principal Investigator: BLANCA DE LA CRUZ, DR University of Seville

Responsible Party: Blanca de la Cruz Torres, PT, PhD, University of Seville Identifier: NCT03433716     History of Changes
Other Study ID Numbers: PNM
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Blanca de la Cruz Torres, University of Seville:
Percutaneous Neuromodulation, radial nerve, pain

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries