Tennis ElbowNCT04442321
Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia
A study testing PENS plus exercise in people with Tennis Elbow, 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 to 65 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- PENS plus exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 30 Dec 2024
- 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 to 65 years
- 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 Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve With Exercises 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 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.
- Conditions
- Tennis Elbow
- Being tested
- PENS plus exercise, Sham PENS plus exercise
- Keywords
- Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve 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
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.
Sham 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
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.
| Study group | Role | What they receive |
|---|---|---|
| PENS plus exercise group | Active comparator | 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. Receives: Other: PENS plus exercise |
| Sham PENS plus exercise group | Sham comparator | 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. Receives: Other: Sham PENS plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Secondary outcomes (5)
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
Measured: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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.
Measured: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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
Measured: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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.
Measured: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
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)
Measured: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Sep 2020
- Primary completion1 Jun 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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
- 60 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
- NCT04442321
- Sponsor's protocol ID
- 19/043
- Status last verified
- Dec 2023
- First submitted
- 21 May 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve With Exercises in Patients With Lateral Epicondylalgia
- ClinicalTrials.gov ID
- NCT04442321
- Acronym / sponsor ID
- 19/043
- Conditions
- Tennis Elbow
- Keywords
- Lateral Epicondylalgia, Lateral Epicondylitis, Lateral Elbow Tendinopathy, Lateral Elbow Pain, Percutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 22 Jun 2020 (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 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.
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 | Active comparator | Other: PENS plus exerciseExperimental: 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 PENS plus exercise group | Sham comparator | Other: Sham PENS plus exerciseSham 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. |
Who may qualify
- Ages
- 18 to 65 years
- 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.
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 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. | Other | PENS plus exercise group |
| Sham 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 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. | Other | Sham PENS plus exercise group |
Primary outcome
Changes in Elbow Pain Intensity between baseline and follow-up periods
Time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale
5 secondary outcomes
Changes in Elbow Related-Disability between baseline and follow-up periods
Time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Changes in Upper Extremity Related-Disability between baseline and follow-up period
Time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Changes in Kinesiophobia between baseline and follow-up periods
Time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Changes in Pain Catastrophizing between baseline and follow-up periods
Time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Changes in Self-perceived Improvement between baseline and follow-up periods
Time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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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 Tennis Elbow, 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: finished, as of the sponsor's last update on 1 Oct 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Elbow Pain Intensity between baseline and follow-up periods (time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention). 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 1 Oct 2025.