Lateral EpicondylitisPNMNCT03433716
Neuromodulation in Lateral Elbow Pain
A study testing Ultrasound-guided Percutaneous Neuromodulation in people with Lateral Epicondylitis, run by Blanca de la Cruz Torres at 1 site in Spain.
Trial summary
Lateral epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or around the lateral epicondyle of the humerus and common extensor tendon (CET) that is aggravated by dorsiflexion and/or supination of the wrist against resistance. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Ultrasound-guided Percutaneous Neuromodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2018to 15 Jun 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of pain in the elbow region at least for three months
- Flares with activity
- Tenderness at or within 2cm of the lateral humeral epicondyle on resisted extension of the wrist and/or the third finger.
Who cannot join
- Participants who had constant or radicular pain
- Any previous surgery or acute trauma in the upper extremity.
- Elbow deformity
- Bilateral symptoms
- Clinical or electrophysiological findings referable to peripheral nerve (ulnar and median) disease and
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Percutaneous Neuromodulation in Patients With Lateral Epicondylalgia: a Pilot Randomized Clinical Trial
Lateral epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or around the lateral epicondyle of the humerus and common extensor tendon (CET) that is aggravated by dorsiflexion and/or supination of the wrist against resistance. Lateral epicondylitis is one of the most common injuries of the elbow, affecting 1-3% of the population.
Therefore, determining an effective intervention that helps manage the condition and lessens the financial burden is important. Passive physical modalities, including electrotherapy and orthotic devices, are common treatments for the management of elbow pain. Passive physical modalities are physical treatments involving a device that does not require active participation by the patient. In a systematic review, 2017, Dion et al examined the effectiveness of passive physical modalities for the treatment of soft tissue injuries of the elbow, but little evidence exists to support or refute their use.
Read more
Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the applicacion of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.
The aim of this pilot study was to examine the effects of a percutaneous neuromodulation intervention in patients with unilateral refractory lateral epicondylitis. Findings from this study may provide further evidence for the relevance of neural tissues in determining the elbow pain and may indicate effects of US-guided NMP technique on the rehabilitation and/or prevention of in patients with unilateral refractory LE.
- Conditions
- Lateral Epicondylitis
- Being tested
- Ultrasound-guided Percutaneous Neuromodulation
- Keywords
- Percutaneous Neuromodulation, radial nerve, pain
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Percutaneous NeuromodulationOther
It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
| Study group | Role | What they receive |
|---|---|---|
| PNM group | Experimental | Subjects were treated for 3 weeks, once a week. Specifically, this consisted in the application of a square wave biphasic electrical current, with 10Hz frequency, a 250µs pulse width, and the maximal tolerable intensity to cause an exacerbated muscle contraction for a total of 1.5 mins, according to the protocol by Valera and Minaya. The subjects were seated while their arms were supported by an arm rest, forearms pronated and elbows moderately flexed. The radial nerve was located at 4cm proximal to the tip of the lateral epicondyle of humerus using an ultrasound machine (cross-section), subsequently, an acupuncture needle (0.30mm x 30mm) was inserted in a short axis approach, perpendicular to the surface of the skin, until the perineurium of the radial nerve (in close proximity). Receives: Other: Ultrasound-guided Percutaneous Neuromodulation |
| Control group | No intervention | the subects of the control group received no any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
average pain at palpation
Numerical rating scale (NRS) (0, points; 10, maximum points).
Measured: Baseline and up to 1 month
Secondary outcomes (3)
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Pain and functional ability
Measured: Baseline and up to 1 month
radial nerve cross-sectional area (CSA)
Cross-sectional area was measure at 4cm proximal to the tip of the lateral epicondyle of humerus
Measured: Baseline and up to 1 month
Strengt-Duration (SD) curves
chronaxie and accommodation index
Measured: Baseline and up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start6 May 2018
- Primary completion6 May 2018
- Study completion15 Jun 2018
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blanca de la Cruz Torres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Blanca de la Cruz Torres, University of Seville
- Investigators
- BLANCA DE LA CRUZ, DR, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433716
- Sponsor's protocol ID
- PNM
- Acronym
- PNM
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Percutaneous Neuromodulation in Patients With Lateral Epicondylalgia: a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03433716
- Acronym / sponsor ID
- PNM / PNM
- Conditions
- Lateral Epicondylitis
- Keywords
- Percutaneous Neuromodulation, radial nerve, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Blanca de la Cruz TorresUniversity, hospital or other
- Study start
- 6 May 2018 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 15 Feb 2018 (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 epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or around the lateral epicondyle of the humerus and common extensor tendon (CET) that is aggravated by dorsiflexion and/or supination of the wrist against resistance. Lateral epicondylitis is one of the most common injuries of the elbow, affecting 1-3% of the population.
Therefore, determining an effective intervention that helps manage the condition and lessens the financial burden is important. Passive physical modalities, including electrotherapy and orthotic devices, are common treatments for the management of elbow pain. Passive physical modalities are physical treatments involving a device that does not require active participation by the patient. In a systematic review, 2017, Dion et al examined the effectiveness of passive physical modalities for the treatment of soft tissue injuries of the elbow, but little evidence exists to support or refute their use.
Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the applicacion of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.
The aim of this pilot study was to examine the effects of a percutaneous neuromodulation intervention in patients with unilateral refractory lateral epicondylitis. Findings from this study may provide further evidence for the relevance of neural tissues in determining the elbow pain and may indicate effects of US-guided NMP technique on the rehabilitation and/or prevention of in patients with unilateral refractory LE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNM group | Experimental | Other: Ultrasound-guided Percutaneous NeuromodulationSubjects were treated for 3 weeks, once a week. Specifically, this consisted in the application of a square wave biphasic electrical current, with 10Hz frequency, a 250µs pulse width, and the maximal tolerable intensity to cause an exacerbated muscle contraction for a total of 1.5 mins, according to the protocol by Valera and Minaya. The subjects were seated while their arms were supported by an arm rest, forearms pronated and elbows moderately flexed. The radial nerve was located at 4cm proximal to the tip of the lateral epicondyle of humerus using an ultrasound machine (cross-section), subsequently, an acupuncture needle (0.30mm x 30mm) was inserted in a short axis approach, perpendicular to the surface of the skin, until the perineurium of the radial nerve (in close proximity). |
| Control group | No intervention | –the subects of the control group received no any treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of pain in the elbow region at least for three months
- Flares with activity
- Tenderness at or within 2cm of the lateral humeral epicondyle on resisted extension of the wrist and/or the third finger.
Key exclusion criteria (5 listed)
- Participants who had constant or radicular pain
- Any previous surgery or acute trauma in the upper extremity.
- Elbow deformity
- Bilateral symptoms
- Clinical or electrophysiological findings referable to peripheral nerve (ulnar and median) disease and
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 |
|---|---|---|
| Ultrasound-guided Percutaneous NeuromodulationIt's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound | Other | PNM group |
Primary outcome
average pain at palpation
Time frame: Baseline and up to 1 month
Numerical rating scale (NRS) (0, points; 10, maximum points).
3 secondary outcomes
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Baseline and up to 1 month
radial nerve cross-sectional area (CSA)
Time frame: Baseline and up to 1 month
Strengt-Duration (SD) curves
Time frame: Baseline and up to 1 month
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 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
BLANCA DE LA CRUZ, DR principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Percutaneous Neuromodulation in people with Lateral Epicondylitis, run by Blanca de la Cruz Torres 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 3 inclusion and 5 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 24 Feb 2021. 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. 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?
average pain at palpation (time frame: Baseline and up to 1 month). 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 24 Feb 2021.