Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

Tennis Elbow Clinical Trial

Official title:

Effectiveness of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve With Exercises in Patients With Lateral Epicondylalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04442321
• Other study ID #: 19/043
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2023
• Source: Universidad Complutense de Madrid
• Contact: Gustavo Plaza, PT, PhD
• Phone: 609578380
• Email: gusplaza[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 exercise therapy in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation plus exercise.

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 effect of the short, mid and long-term of PENS on intensity of pain as measured by numeric pain rating scale and disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program.

Aim #2: The secondary aim of the study is to compare the effect of the short, medium and long-term of PENS on disability as measured by DASH questionnaire, and psychological factors (fear and avoidance and catastrophism) and Global Rating of Change (GRoC) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Other:
• PENS plus exercise
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 Froshe 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 per week Self-management loaded exercises prescribed by a physical therapist, two times per week.
• Sham PENS plus exercise
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 Froshe The electrical current will not be working, and the needles will be placed during 30 minutes: - Administration - One per week Self-management loaded exercises prescribed by a physical therapist, two times per week.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Elbow Pain Intensity between baseline and follow-up periods	Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale	Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary	Changes in Elbow Related-Disability between baseline and follow-up periods	Measured with Patient Rated Tennis Elbow Evaluation (PRTEE). It is a 15-item questionnaire designed to measure forearm pain and disability in patients	Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary	Changes in Upper Extremity Related-Disability between baseline and follow-up period	Measured with Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. It includes 30 items assessing (1) degree of difficulty during the preceding week in performing several physical activities because of problems in a upper extremity (21 items), (2) severity of each of the symptoms of pain, activity related pain, tingling, weakness, and stiffness (5 items), and (3) the problem's effect on social activities, work, and sleep and its psychological impact (4 items). Each item is answered on a 5-point scale ranging from 1 (no difficulty to perform, no symptom, or no impact) to 5 (unable to do, very severe symptom, or high impact). The responses to the 30 items are summed to form a raw score that is then converted to a scale from 0 to 100 with a formula. A higher score reflects greater disability.	Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary	Changes in Kinesiophobia between baseline and follow-up periods	Tampa Scale for Kinesiophobia. To assess the fear of movement and pain-related fear. The 11 items are scored 1-4, with total scores ranging from 11 to 44. The addition of all the points obtained from each of the items results in the level of kinesiophobia, with higher scores indicating greater perceived kinesiophobia	Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary	Changes in Pain Catastrophizing between baseline and follow-up periods	Pain Catastrophizing Scale (PCS). This tool is a 13-item questionnaire designed to measure the three components of pain-related catastrophizing: rumination, magnification, and helplessness, resulting in a unique score. Each item is responded to on a 5-point scale (0 not at all, 4 all the time) relating the degree to which the individual experiences a thought or feeling of a painful situation.	Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary	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)	Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention