Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia
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| ClinicalTrials.gov Identifier: NCT04576195 |
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Recruitment Status :
Not yet recruiting
First Posted : October 6, 2020
Last Update Posted : October 6, 2020
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tennis Elbow | Other: Real PENS Other: Sham PENS | Not Applicable |
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), extent of pain and global rating of change in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Immediate Neurophysiological Effects of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia |
| Estimated Study Start Date : | October 9, 2020 |
| Estimated Primary Completion Date : | June 1, 2021 |
| Estimated Study Completion Date : | June 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Real PENS
One single session of PENS
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Other: Real PENS
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. |
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Sham Comparator: Sham PENS
One single session of Sham-PENS
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Other: Sham PENS
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 |
- Changes in Pressure pain threshold using an algometer [ Time Frame: Baseline and immediate (10 minutes after intervention) ]Measurement of pressure pain threshold in the lateral epicondyle, radial nerve in the spiral groove, C5-C6 zygapophyseal joints, and the tibialis anterior muscle.
- Changes in Pain Intensity: Visual Analogue Scale [ Time Frame: Baseline and immediate (10 minutes after intervention) ]Pain intensity measured with a 100 mm (0 - No pain - 100 The worst pain) visual analogue scale
- Changes in Pain-Free Grip Strength [ Time Frame: Baseline and immediate (10 minutes after intervention) ]Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer
- Changes in Area of pain [ Time Frame: Baseline and immediate (10 minutes after intervention) ]The participants will paint the area of extension of their pain in a body chart. The area in mm^2 will be calculated using a software
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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): NCT04576195
| Contact: Gustavo Plaza, PT, PhD | 609578380 ext +34 | gusplaza@ucm.es |
| Spain | |
| Universidad Complutense de Madrid | |
| Madrid, Spain, 28040 | |
| Responsible Party: | Universidad Complutense de Madrid |
| ClinicalTrials.gov Identifier: | NCT04576195 |
| Other Study ID Numbers: |
19/043 (b) |
| First Posted: | October 6, 2020 Key Record Dates |
| Last Update Posted: | October 6, 2020 |
| Last Verified: | May 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lateral Epicondylalgia Lateral Epicondylitis Lateral Elbow Tendinopathy Lateral Elbow Pain Percutaneous Electrical Nerve Stimulation |
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Tennis Elbow Elbow Tendinopathy Tendinopathy Muscular Diseases |
Musculoskeletal Diseases Arm Injuries Wounds and Injuries Tendon Injuries |