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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04442321
Other study ID # 19/043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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