Percutaneous Electrical Nerve StimulationNCT05432973
Percutaneous Electrical Nerve Stimulation Compared to Passive Assisted Neurodynamics in Brachial Plexus Neuropathy
A study testing Percutaneous Electrical Nerve Stimulation and Neurodynamic and manual therapy in people with Percutaneous Electrical Nerve Stimulation and Peripheral Neuropathy, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Brachial plexus neuropathies, specifically of the median, radial, ulnar, suprascapular, axillary and dorsal scapular nerves, can arise when a peripheral nerve trunk or nerve root is subjected to injury, compression, inflammation or ischemia, resulting in reduced physical capabilities of the peripheral nervous system. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Percutaneous Electrical Nerve Stimulation, Peripheral Neuropathy, Neuropathic Pain
- What is being tested?
- Percutaneous Electrical Nerve Stimulation and Neurodynamic and manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 1 Jan 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with upper limb neural symptomatology between 18 and 60 years of age, presenting two or more of the following conditions:
- Paresthesias in any territory of the shoulder girdle, arm or hand
- Pain at rest in any territory of the upper extremity.
- Pain at rest in any upper extremity territory
- Sensations of electric shock in any territory of the shoulder girdle, arm or hand.
- Allodynia or cutaneous hyperalgesia in any territory of the shoulder girdle, arm or hand.
Who cannot join
- Less than 2 weeks of evolution
- Fracture in the affected upper extremity
- Suffering from another joint disorder such as osteoarthritis or rheumatic disease
- Suffering from generalized neuropathies due to neuromuscular disease or medication
- Inability to understand instructions or sign informed consent.
- Wearing a pacemaker or any electrical device implanted in the body
Show all 9Show fewer
- Epilepsy
- Aversion or fear of needles
- Pregnant.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Physiotherapy and exercise center Origenkinesis
Alcorcón, Madrid, 28922
Víctor Navarro López, PhD student, 697371075, victor.navarro@urjc.es
About this study
Official title: Efficacy of Percutaneous Electrical Nerve Stimulation Compared With Passive Assisted Neurodynamics in Brachial Plexus Neuropathy: a Pilot Randomized Controlled Trial.
Brachial plexus neuropathies, specifically of the median, radial, ulnar, suprascapular, axillary and dorsal scapular nerves, can arise when a peripheral nerve trunk or nerve root is subjected to injury, compression, inflammation or ischemia, resulting in reduced physical capabilities of the peripheral nervous system. Although pharmacological treatments provide mild symptomatic relief in the short term, they are not without side effects.
Neurostimulation techniques may be an effective treatment option for peripheral brachial plexus neuropathies. Some of these procedures are transcutaneous electrical nerve stimulation (TENS) or percutaneous electrical nerve stimulation (PENS). Although some case series have documented a positive effect in relation to ultrasound-guided PENS for subjects with subacromial pain syndrome or postsurgical pain, the lack of studies, to our knowledge, analyzing the effects of percutaneous electrical nerve stimulation, in relation to pain and paresthesias in subjects with brachial plexus neuropathy, warrants investigation for this goal.
- Being tested
- Percutaneous Electrical Nerve Stimulation, Neurodynamic and manual therapy
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Electrical Nerve StimulationProcedure or surgery
In the PENS treatment, a biphasic continuous waveform current with a frequency of 2 Hz, a pulse width of 50 microseconds and an intensity that produces visible motor responses of the innervated muscles was used, below the patient's pain threshold. The NT6021 Percutaneous Neuromodulation equipment of the Nutek® brand distributed by Fisiolab Ibérica® was used. This equipment has the CE marking, which denotes compliance with the requirements of the legislation of Royal Decree 414/1996 of March 1, which regulates medical devices. B.O.E. of April 24, 1996
Neurodynamic and manual therapyProcedure or surgery
The manual therapy consisted of passive-assisted mobilization and massage therapy of the muscular and fascial tissue, beginning with the cervical area, kneading while asking the patient to rotate the neck and then in the same way along the muscles and soft tissues innervated by the target nerve.
Neurodynamic was performed in a passive-assisted manner, combining the patient's cervical mobilizations with the mobility of the upper limbs adapted to each case.
| Study group | Role | What they receive |
|---|---|---|
| PENS | Experimental | Not described Receives: Procedure: Percutaneous Electrical Nerve Stimulation |
| Neurodynamics and manual therapy | Active comparator | Not described Receives: Procedure: Neurodynamic and manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lanss Scale
Useful to identify patients with a pain experience dominated by neuropathic mechanisms. It is based on the analysis of sensory description and exploration of sensory dysfunction at the patient's bedside. It consists of 7 items and is scored from 0 to 24. At a score of less than 12, the neuropathic component is considered unlikely. A score greater than or equal to 12 is considered probable neuropathic pain. It is a validated scale for patients with neuropathic pain.
Measured: 10 minutes
Pain Detect Scale
Screening questionnaire for neuropathic pain. This scale consists of a section dedicated to pain intensity and another that is responsible for assessing the qualitative aspect of pain, i.e., identifying whether the pain is of neuropathic characteristics. In the total of this scale the maximum possible score is 38 points and the minimum -1. For screening purposes, a score less than or equal to 12 is considered an unlikely neuropathic component. A score greater than or equal to 19 concludes that the neurological component in pain is probable.
Measured: 10 minutes
Numerical Pain Rating Scale (NPRS)
A unique 11-point numerical scale validated in patients with various painful conditions. Data obtained through NPRS are easily documented, intuitively interpretable, and meet regulatory requirements for pain assessment and documentation. This scale is reliable and validated for assessing patients with pain20. Score 0 corresponds to "no pain" and score 10 corresponds to "maximum possible pain". In this study, patients were asked to mark their maximum pain detected in the last week (NPRS Max) and their minimum pain detected in the last week (NPRS Min).
Measured: 1 minute
Secondary outcomes (3)
Neural stress test
Nerves react to certain mechanical stresses and forces, but to establish positivity of such tests, the possibilities of "false positivity" due to other non-nerve structures must first be eliminated. The determination of a positive neural test is established by provocation and symptom relief techniques. In this outcome measure only a positive or negative test was considered. The test was positive if the patient's neural symptoms were reproduced during provocation, or negative if no such symptoms occurred.
Measured: 5 minutes
DASH scale
It is a validated scale for assessing upper limb functionality. It is an instrument that can be completed by the patient with the help of the physical therapist. It consists of 30 questions that assess certain symptoms, as well as the ability to perform activities, ranging from 1 to 5, with 1=no difficulty and 5=maximum difficulty. The higher the score, the greater the upper limb disability.
Measured: 5 minutes
Thermography
A thermal camera, HT-02D infrared thermographic and visible light camera with IR 1024 pixels and -20~300°C, 6Hz refresh rate, infrared thermometer was used. The thermograph indicates the approximate temperature of the body segment to be examined by focusing it with the thermographic camera.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Electrical Nerve StimulationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432973
- Sponsor's protocol ID
- PENS210722
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Percutaneous Electrical Nerve Stimulation Compared With Passive Assisted Neurodynamics in Brachial Plexus Neuropathy: a Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05432973
- Acronym / sponsor ID
- PENS210722
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 27 Jun 2022 (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.
Brachial plexus neuropathies, specifically of the median, radial, ulnar, suprascapular, axillary and dorsal scapular nerves, can arise when a peripheral nerve trunk or nerve root is subjected to injury, compression, inflammation or ischemia, resulting in reduced physical capabilities of the peripheral nervous system. Although pharmacological treatments provide mild symptomatic relief in the short term, they are not without side effects.
Neurostimulation techniques may be an effective treatment option for peripheral brachial plexus neuropathies. Some of these procedures are transcutaneous electrical nerve stimulation (TENS) or percutaneous electrical nerve stimulation (PENS). Although some case series have documented a positive effect in relation to ultrasound-guided PENS for subjects with subacromial pain syndrome or postsurgical pain, the lack of studies, to our knowledge, analyzing the effects of percutaneous electrical nerve stimulation, in relation to pain and paresthesias in subjects with brachial plexus neuropathy, warrants investigation for this goal.
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 | Experimental | Procedure: Percutaneous Electrical Nerve Stimulation |
| Neurodynamics and manual therapy | Active comparator | Procedure: Neurodynamic and manual therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects with upper limb neural symptomatology between 18 and 60 years of age, presenting two or more of the following conditions:
- Paresthesias in any territory of the shoulder girdle, arm or hand
- Pain at rest in any territory of the upper extremity.
- Pain at rest in any upper extremity territory
- Sensations of electric shock in any territory of the shoulder girdle, arm or hand.
Key exclusion criteria (9 listed)
- Less than 2 weeks of evolution
- Fracture in the affected upper extremity
- Suffering from another joint disorder such as osteoarthritis or rheumatic disease
- Suffering from generalized neuropathies due to neuromuscular disease or medication
- Inability to understand instructions or sign informed consent.
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 |
|---|---|---|
| Percutaneous Electrical Nerve StimulationIn the PENS treatment, a biphasic continuous waveform current with a frequency of 2 Hz, a pulse width of 50 microseconds and an intensity that produces visible motor responses of the innervated muscles was used, below the patient's pain threshold. The NT6021 Percutaneous Neuromodulation equipment of the Nutek® brand distributed by Fisiolab Ibérica® was used. This equipment has the CE marking, which denotes compliance with the requirements of the legislation of Royal Decree 414/1996 of March 1, which regulates medical devices. B.O.E. of April 24, 1996 | Procedure or surgery | PENS |
| Neurodynamic and manual therapyThe manual therapy consisted of passive-assisted mobilization and massage therapy of the muscular and fascial tissue, beginning with the cervical area, kneading while asking the patient to rotate the neck and then in the same way along the muscles and soft tissues innervated by the target nerve. Neurodynamic was performed in a passive-assisted manner, combining the patient's cervical mobilizations with the mobility of the upper limbs adapted to each case. | Procedure or surgery | Neurodynamics and manual therapy |
Primary outcome
Lanss Scale
Time frame: 10 minutes
Useful to identify patients with a pain experience dominated by neuropathic mechanisms. It is based on the analysis of sensory description and exploration of sensory dysfunction at the patient's bedside. It consists of 7 items and is scored from 0 to 24. At a score of less than 12, the neuropathic component is considered unlikely. A score greater than or equal to 12 is considered probable neuropathic pain. It is a validated scale for patients with neuropathic pain.
Pain Detect Scale
Time frame: 10 minutes
Screening questionnaire for neuropathic pain. This scale consists of a section dedicated to pain intensity and another that is responsible for assessing the qualitative aspect of pain, i.e., identifying whether the pain is of neuropathic characteristics. In the total of this scale the maximum possible score is 38 points and the minimum -1. For screening purposes, a score less than or equal to 12 is considered an unlikely neuropathic component. A score greater than or equal to 19 concludes that the neurological component in pain is probable.
Numerical Pain Rating Scale (NPRS)
Time frame: 1 minute
A unique 11-point numerical scale validated in patients with various painful conditions. Data obtained through NPRS are easily documented, intuitively interpretable, and meet regulatory requirements for pain assessment and documentation. This scale is reliable and validated for assessing patients with pain20. Score 0 corresponds to "no pain" and score 10 corresponds to "maximum possible pain". In this study, patients were asked to mark their maximum pain detected in the last week (NPRS Max) and their minimum pain detected in the last week (NPRS Min).
3 secondary outcomes
Neural stress test
Time frame: 5 minutes
DASH scale
Time frame: 5 minutes
Thermography
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Yes
Related trials for Percutaneous Electrical Nerve Stimulation
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Electrical Nerve Stimulation and Neurodynamic and manual therapy in people with Percutaneous Electrical Nerve Stimulation and Peripheral Neuropathy, run by Universidad Rey Juan Carlos 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Víctor Navarro López, PhD student (697371075, victor.navarro@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lanss Scale (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 27 Jun 2022.