Clinical trial NCT04442321: Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
Official title: Effectiveness of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve With Exercises in Patients With Lateral Epicondylalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tennis Elbow
Keywords: Lateral Epicondylalgia
Lateral Epicondylitis
Lateral Elbow Tendinopathy
Lateral Elbow Pain
Percutaneous Electrical Nerve Stimulation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Elbow Pain Intensity between baseline and follow-up periods
timeFrame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary outcomes:
measure: Changes in Elbow Related-Disability between baseline and follow-up periods
timeFrame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
measure: Changes in Upper Extremity Related-Disability between baseline and follow-up period
timeFrame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
measure: Changes in Kinesiophobia between baseline and follow-up periods
timeFrame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
measure: Changes in Pain Catastrophizing between baseline and follow-up periods
timeFrame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
measure: Changes in Self-perceived Improvement between baseline and follow-up periods
timeFrame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References: