Clinical trial NCT03856125: Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
Official title: Effectiveness of a Combined Treatment Percutaneous Electrical Stimulation on Radial Nerve With an Exercise Program in Patients With Lateral Epicondylalgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Tennis elbow
Lateral epicondylalgia
Lateral elbow tendinopathy
Lateral elbow pain
Percutaneous electrical stimulation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 immediate, short, medium and long-term of PENS on intensity of pain as measured by visual analogue scale (VAS) 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 immediate, short, medium and long-term of PENS on pain free grip strength, disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) and DASH questionnaire and pressure pain threshold (PPT) and area and distribution of pain in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program, and determine if psychological factors (fear and avoidance and catastrophism) change with any of the treatments and if is related with the primary and secondary outcomes.

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: Pain Intensity: visual analogue scale
timeFrame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Secondary outcomes:
measure: Patient Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
measure: Pain free grip strength
timeFrame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks
measure: Pressure pain threshold using an algometer
timeFrame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
measure: Area of pain
timeFrame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
measure: Pain distribution
timeFrame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
measure: Kinesiophobia
timeFrame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
measure: Pain catastrophizing
timeFrame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References: