Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

NCT03856125 | Withdrawn

• 1 other identifier: CI: 19/043
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

Tennis elbow; Lateral epicondylalgia; Lateral elbow tendinopathy; Lateral elbow pain; Percutaneous electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Pain Intensity: visual analogue scale

  Pain intensity measured with a 100mm (0 - No pain - 100 The worst pain) visual analogue scale

  Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks

Secondary Outcomes (8)

• Patient Rated Tennis Elbow Evaluation (PRTEE)

  Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks

• Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

  Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks

• Pain free grip strength

  Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks

• Pressure pain threshold using an algometer

  Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks

• Area of pain

  Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks

Study Arms (2)

PENS plus exercise group

EXPERIMENTAL

4-week intervention program with 2 weekly treatment sessions, one of percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise.

Other: PENS plus exercise

Sham PENS plus exercise group

SHAM COMPARATOR

4-week intervention program with 2 weekly treatment sessions, one of sham percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise.

Other: Sham PENS plus exercise

Interventions

PENS plus exercise OTHER

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's 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

PENS plus exercise group

Sham PENS plus exercise OTHER

The technique will be performed on the radial nerve, the places of the needle's. 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 wil be placed at the at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe's. The current will not be working, and the needles will be placed during 30 minutes. \- Administration - One per week

Sham PENS plus exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:
• pain during palpation of lateral epicondyle
• pain on resisted wrist extension
• pain on resisted middle finger extension
• pain during hand-grip.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Exercise

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 27, 2019
• Study Start: April 1, 2019
• Primary Completion: May 21, 2020
• Study Completion: May 21, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

ES (1)