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Neuromodulation in Lateral Elbow Pain (PNM)

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound-guided Percutaneous Neuromodulation
Sponsored by
Blanca de la Cruz Torres
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Percutaneous Neuromodulation, radial nerve, pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Blanca de La Cruz Torres

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PNM group

Control group

Arm Description

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).

the subects of the control group received no any treatment

Outcomes

Primary Outcome Measures

average pain at palpation
Numerical rating scale (NRS) (0, points; 10, maximum points).

Secondary Outcome Measures

Patient-Rated Tennis Elbow Evaluation (PRTEE)
Pain and functional ability
radial nerve cross-sectional area (CSA)
Cross-sectional area was measure at 4cm proximal to the tip of the lateral epicondyle of humerus
Strengt-Duration (SD) curves
chronaxie and accommodation index

Full Information

First Posted
February 1, 2018
Last Updated
February 21, 2021
Sponsor
Blanca de la Cruz Torres
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1. Study Identification

Unique Protocol Identification Number
NCT03433716
Brief Title
Neuromodulation in Lateral Elbow Pain
Acronym
PNM
Official Title
Ultrasound-guided Percutaneous Neuromodulation in Patients With Lateral Epicondylalgia: a Pilot Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 6, 2018 (Actual)
Primary Completion Date
May 6, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Blanca de la Cruz Torres

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Percutaneous Neuromodulation, radial nerve, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNM group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
the subects of the control group received no any treatment
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided Percutaneous Neuromodulation
Intervention Description
It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
Primary Outcome Measure Information:
Title
average pain at palpation
Description
Numerical rating scale (NRS) (0, points; 10, maximum points).
Time Frame
Baseline and up to 1 month
Secondary Outcome Measure Information:
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Description
Pain and functional ability
Time Frame
Baseline and up to 1 month
Title
radial nerve cross-sectional area (CSA)
Description
Cross-sectional area was measure at 4cm proximal to the tip of the lateral epicondyle of humerus
Time Frame
Baseline and up to 1 month
Title
Strengt-Duration (SD) curves
Description
chronaxie and accommodation index
Time Frame
Baseline and up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BLANCA DE LA CRUZ, DR
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blanca de La Cruz Torres
City
Seville
ZIP/Postal Code
41010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neuromodulation in Lateral Elbow Pain

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