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Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Real PENS
Sham PENS
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:

    1. pain during palpation of lateral epicondyle
    2. pain on resisted wrist extension
    3. pain on resisted middle finger extension
    4. pain during hand-grip

Exclusion Criteria:

  • History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb.
  • Neurological disorders, inflammatory and/or degenerative diseases.
  • Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before.
  • Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
  • Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
  • Contraindications of electrical current application

Sites / Locations

  • Universidad Complutense de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real PENS

Sham PENS

Arm Description

One single session of PENS

One single session of Sham-PENS

Outcomes

Primary Outcome Measures

Changes in Pressure pain threshold using an algometer
Measurement of pressure pain threshold in the lateral epicondyle, radial nerve in the spiral groove, C5-C6 zygapophyseal joints, and the tibialis anterior muscle.

Secondary Outcome Measures

Changes in Pain Intensity: Visual Analogue Scale
Pain intensity measured with a 100 mm (0 - No pain - 100 The worst pain) visual analogue scale
Changes in Pain-Free Grip Strength
Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer
Changes in Self-perceived Improvement between baseline and follow-up periods
Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover)

Full Information

First Posted
September 28, 2020
Last Updated
March 22, 2023
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04576195
Brief Title
Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia
Official Title
Immediate Neurophysiological Effects of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

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

5. Study Description

Brief Summary
Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. Several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation has shown reduce pain in several conditions. Percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia. Hypothesis: Percutaneous electrical stimulation on radial nerve plus in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation
Detailed Description
Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve. Study Aims: Aim #1: The primary aim of the study is to compare the immediate effect of a single session of PENS on pressure pain sensitivity as measured by pressure pain threshold in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS Aim #2: The secondary aim of the study is to compare the immediate effect on pain free grip strength, on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve Stimulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Real PENS
Arm Type
Experimental
Arm Description
One single session of PENS
Arm Title
Sham PENS
Arm Type
Sham Comparator
Arm Description
One single session of Sham-PENS
Intervention Type
Other
Intervention Name(s)
Real PENS
Intervention Description
The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following: Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current: TENS Frequency 2 Hz TENS Pulse width - 250 microseconds Duration - 30 minutes. TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity. Administration - One single session.
Intervention Type
Other
Intervention Name(s)
Sham PENS
Intervention Description
The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following: Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's The electrical current will not be working, and the needles will be placed during 30 minutes: - Administration - One single session
Primary Outcome Measure Information:
Title
Changes in Pressure pain threshold using an algometer
Description
Measurement of pressure pain threshold in the lateral epicondyle, radial nerve in the spiral groove, C5-C6 zygapophyseal joints, and the tibialis anterior muscle.
Time Frame
Baseline and immediate (10 minutes after intervention)
Secondary Outcome Measure Information:
Title
Changes in Pain Intensity: Visual Analogue Scale
Description
Pain intensity measured with a 100 mm (0 - No pain - 100 The worst pain) visual analogue scale
Time Frame
Baseline and immediate (10 minutes after intervention)
Title
Changes in Pain-Free Grip Strength
Description
Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer
Time Frame
Baseline and immediate (10 minutes after intervention)
Title
Changes in Self-perceived Improvement between baseline and follow-up periods
Description
Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover)
Time Frame
Time Frame: Baseline,10 minutes post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test: pain during palpation of lateral epicondyle pain on resisted wrist extension pain on resisted middle finger extension pain during hand-grip Exclusion Criteria: History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb. Neurological disorders, inflammatory and/or degenerative diseases. Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before. Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy. Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases). Contraindications of electrical current application
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

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Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia

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