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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
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.
Universidad Complutense de Madrid
Madrid, Madrid, Spain
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
Time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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
Time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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.
Time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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
Time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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.
Time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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)
Time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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