Lateral EpicondylitisNCT03856125
Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
A study testing PENS plus exercise in people with Lateral Epicondylitis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- PENS plus exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 21 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Combined Treatment Percutaneous Electrical Stimulation on Radial Nerve With an Exercise Program in Patients With Lateral Epicondylalgia
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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- PENS plus exercise, Sham PENS plus exercise
- Keywords
- Tennis elbow, Lateral epicondylalgia, Lateral elbow tendinopathy, Lateral elbow pain, Percutaneous electrical stimulation
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENS plus exerciseOther
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
Sham PENS plus exerciseOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham PENS plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity: visual analogue scale
Pain intensity measured with a 100mm (0 - No pain - 100 The worst pain) visual analogue scale
Measured: 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)
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.
Measured: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
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.
Measured: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Pain free grip strength
Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer
Measured: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks
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.
Measured: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
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
Measured: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
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
Measured: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
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
Measured: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
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.
Measured: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Apr 2019
- Primary completion21 May 2020
- Study completion21 May 2020
Why it stopped: Covid19 locked down
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856125
- Sponsor's protocol ID
- CI: 19/043
- Status last verified
- May 2020
- First submitted
- 20 Feb 2019
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Treatment Percutaneous Electrical Stimulation on Radial Nerve With an Exercise Program in Patients With Lateral Epicondylalgia
- ClinicalTrials.gov ID
- NCT03856125
- Acronym / sponsor ID
- CI: 19/043
- Conditions
- Lateral Epicondylitis
- Keywords
- Tennis elbow, Lateral epicondylalgia, Lateral elbow tendinopathy, Lateral elbow pain, Percutaneous electrical stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid19 locked down
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENS plus exercise group | Experimental | Other: PENS plus exercise4-week intervention program with 2 weekly treatment sessions, one of percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise. |
| Sham PENS plus exercise group | Sham comparator | Other: Sham PENS plus exercise4-week intervention program with 2 weekly treatment sessions, one of sham percutaneous electrical stimulation and supervised exercise and the other one, domiciliary exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENS plus exerciseThe 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 | PENS plus exercise group |
| Sham PENS plus exerciseThe 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 | Other | Sham PENS plus exercise group |
Primary outcome
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
8 secondary outcomes
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
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
Pain free grip strength
Time frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks
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
Area of pain
Time frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Pain distribution
Time frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Kinesiophobia
Time frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Pain catastrophizing
Time frame: Change from baseline to 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENS plus exercise in people with Lateral Epicondylitis, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity: visual analogue scale (time frame: Change from baseline to immediate (single session); 4 weeks; 8 weeks; 16 weeks; 28 weeks; 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.