Back to resultsUltrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
Primary Purpose
Tennis Elbow
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PENS plus exercise
Sham PENS plus exercise
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow focused on measuring Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve Stimulation
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.
Sites / Locations
- Universidad Complutense de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
PENS plus exercise group
Sham PENS plus exercise group
Arm Description
Experimental: PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently . It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
Sham Comparator: Sham PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently. It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
Outcomes
Primary Outcome Measures
Changes in Elbow Pain Intensity between baseline and follow-up periods
Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale
Secondary Outcome Measures
Changes in Elbow Related-Disability between baseline and follow-up periods
Measured with Patient Rated Tennis Elbow Evaluation (PRTEE). It is a 15-item questionnaire designed to measure forearm pain and disability in patients
Changes in Upper Extremity Related-Disability between baseline and follow-up period
Measured with 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.
Changes in Kinesiophobia between baseline and follow-up periods
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
Changes in Pain Catastrophizing between baseline and follow-up periods
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.
Changes in Self-perceived Improvement between baseline and follow-up periods
Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover)
Full Information
NCT ID
NCT04442321
First Posted
May 21, 2020
Last Updated
January 19, 2023
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04442321
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PENS plus exercise group
Arm Type
Active Comparator
Arm Description
Experimental: PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently . It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
Arm Title
Sham PENS plus exercise group
Arm Type
Sham Comparator
Arm Description
Sham Comparator: Sham PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently. It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
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
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
Self-management loaded exercises prescribed by a physical therapist, two times per week.
Intervention Type
Other
Intervention Name(s)
Sham 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
The electrical current will not be working, and the needles will be placed during 30 minutes:
- Administration - One per week
Self-management loaded exercises prescribed by a physical therapist, two times per week.
Primary Outcome Measure Information:
Title
Changes in Elbow Pain Intensity between baseline and follow-up periods
Description
Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale
Time Frame
Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary Outcome Measure Information:
Title
Changes in Elbow Related-Disability between baseline and follow-up periods
Description
Measured with Patient Rated Tennis Elbow Evaluation (PRTEE). It is a 15-item questionnaire designed to measure forearm pain and disability in patients
Time Frame
Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Title
Changes in Upper Extremity Related-Disability between baseline and follow-up period
Description
Measured with 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.
Time Frame
Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Title
Changes in Kinesiophobia between baseline and follow-up periods
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
Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Title
Changes in Pain Catastrophizing between baseline and follow-up periods
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
Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Title
Changes in Self-perceived Improvement between baseline and follow-up periods
Description
Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover)
Time Frame
Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo Plaza, PT, PhD
Phone
609578380
Ext
+34
Email
gusplaza@ucm.es
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Plaza, PT, PhD
Phone
609578380
Ext
+34
Email
gusplaza@ucm.es
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
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