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Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03856125
Recruitment Status : Withdrawn (Covid19 locked down)
First Posted : February 27, 2019
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Universidad Complutense de Madrid

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE February 27, 2019
Last Update Posted Date May 26, 2020
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
Pain Intensity: visual analogue scale [ Time Frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
Pain intensity measured with a 100mm (0 - No pain - 100 The worst pain) visual analogue scale
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
Pain Intensity: visual analogue scale [ Time Frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
Pain intensity measured with a 100mm (0 - No pain - 100 The worst pain) visual analogue scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • Patient Rated Tennis Elbow Evaluation (PRTEE) [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
    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 [ Time Frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Patient Rated Tennis Elbow Evaluation (PRTEE) [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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 [ Time Frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks ]
    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.
  • Different sequences during upper limb neurodynamic test for radial nerve [ Time Frame: Baseline ]
    Consider positive or negative. Positive test requires reproduction of the patient's lateral elbow pain and alteration of symptoms by a sensitization maneuver.
  • Pain intensity during the different sequences of upper limb neurodynamic test for radial neve: visual analogue scale [ Time Frame: Baseline ]
    Pain intensity measured with a 100mm (0 - No pain - 100 The worst pain) visual during upper limb neurodynamic test
  • Intensity of paresthesia elicited during upper limb neurodynamic test for radial nerve [ Time Frame: Baseline ]
    Evaluated using a 0 to 2 scale: 0= no paresthesia, 1= mild to moderate, 2= severe.
  • Distribution and area of pain during the different sequences of upper limb neurodynamic test for radial nerve [ Time Frame: Baseline ]
    The participants will paint the area of extension of their pain perceived during the upper limb neurodynamic test for radial nerve variations. The area in mm^2 will be calculated using a software.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
Official Title  ICMJE Effectiveness of a Combined Treatment Percutaneous Electrical Stimulation on Radial Nerve With an Exercise Program in Patients With Lateral Epicondylalgia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lateral Epicondylitis
Intervention  ICMJE
  • Other: PENS plus exercise

    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
  • Other: Sham PENS plus exercise

    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

Study Arms  ICMJE
  • Experimental: PENS plus exercise group
    4-week intervention program with 2 weekly treatment sessions, one of percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise.
    Intervention: Other: PENS plus exercise
  • Sham Comparator: Sham PENS plus exercise group
    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: Other: Sham PENS plus exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
38
Actual Study Completion Date  ICMJE May 21, 2020
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03856125
Other Study ID Numbers  ICMJE CI: 19/043
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universidad Complutense de Madrid
Study Sponsor  ICMJE Universidad Complutense de Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad Complutense de Madrid
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP