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Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

Primary Purpose

Lateral Epicondylitis

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PENS plus exercise
Sham PENS plus exercise
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Tennis elbow, Lateral epicondylalgia, Lateral elbow tendinopathy, Lateral elbow pain, Percutaneous electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad Complutense de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PENS plus exercise group

Sham PENS plus exercise group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Rated Tennis Elbow Evaluation (PRTEE)
It is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: pain and function.
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.
Pain free grip strength
Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer
Pressure pain threshold using an algometer
Measurement of pressure pain threshold in the lateral epicondyle, radial nerve in the spiral groove, C5-C6 zygapophyseal joints, and the tibialis anterior muscle.
Area of pain
The participants will paint the area of extension of their pain in a body chart. The area in mm^2 will be calculated using a software
Pain distribution
The pain distribution will be classified as 0=no pain, 1=pain only proximal and lateral elbow, 2=distal pain to the elbow (forearm and wrist), 3= pain in other regions (arm, shoulder and neck) using the painted region in the body chart
Kinesiophobia
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
Pain catastrophizing
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.

Full Information

First Posted
February 20, 2019
Last Updated
May 21, 2020
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03856125
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Covid19 locked down
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
May 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Tennis elbow, Lateral epicondylalgia, Lateral elbow tendinopathy, Lateral elbow pain, Percutaneous electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENS plus exercise group
Arm Type
Experimental
Arm Description
4-week intervention program with 2 weekly treatment sessions, one of percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise.
Arm Title
Sham PENS plus exercise group
Arm Type
Sham Comparator
Arm Description
4-week intervention program with 2 weekly treatment sessions, one of sham percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise.
Intervention Type
Other
Intervention Name(s)
PENS plus exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham PENS plus exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Intensity: visual analogue scale
Description
Pain intensity measured with a 100mm (0 - No pain - 100 The worst pain) visual analogue scale
Time Frame
Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Secondary Outcome Measure Information:
Title
Patient Rated Tennis Elbow Evaluation (PRTEE)
Description
It is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: pain and function.
Time Frame
Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
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
Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Title
Pain free grip strength
Description
Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer
Time Frame
Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks
Title
Pressure pain threshold using an algometer
Description
Measurement of pressure pain threshold in the lateral epicondyle, radial nerve in the spiral groove, C5-C6 zygapophyseal joints, and the tibialis anterior muscle.
Time Frame
Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Title
Area of pain
Description
The participants will paint the area of extension of their pain in a body chart. The area in mm^2 will be calculated using a software
Time Frame
Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Title
Pain distribution
Description
The pain distribution will be classified as 0=no pain, 1=pain only proximal and lateral elbow, 2=distal pain to the elbow (forearm and wrist), 3= pain in other regions (arm, shoulder and neck) using the painted region in the body chart
Time Frame
Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Title
Kinesiophobia
Description
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
Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Title
Pain catastrophizing
Description
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
Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

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Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

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