HealthyNCT05549700
The Application of Neuromodulation in Sciatic Nerve
A study testing Neuromodulation in people with Healthy, run by University of Seville at 1 site in Spain.
Trial summary
The objective of this study will be to analyze the muscle activity of the short head (SHBF) and long head of the biceps femoris (LHBF) after the application of ultrasound-guided percutaneous neuromodulation (NMP) in the tibial or common fibular nerve compartment of the sciatic nerve. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neuromodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 30 Dec 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
Who cannot join
- Subjects that have lumbar area of the back, scoliosis, lower limb dysmetria
- Subjects undergone any surgical intervention in the lumbar area or lower limbs
- Subjects that present acute or unresolved injury in the last 6 months in the lower limbs
- Subjects under treatment drug treatment
- Subjects that they are afraid of needles or electric current
- Subjects with epileptic
- Pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Fascicular Anatomy of Nerve May Influence the Muscular Activity of the Biceps Femoris After Applying Ultrasound-guided Percutaneous Neuromodulation
The objective of this study will be to analyze the muscle activity of the short head (SHBF) and long head of the biceps femoris (LHBF) after the application of ultrasound-guided percutaneous neuromodulation (NMP) in the tibial or common fibular nerve compartment of the sciatic nerve.
Authors will recruit healthy subjects and they will receive asymmetric biphasic rectangular current through a needle into the sciatic nerve. The sample was divided into two groups: one to which the technique was applied in the lateral compartment and another group, in the medial compartment of the nerve. The protocol used was 5 seconds of stimulation, 55 seconds of rest for 5 minutes at a frequency of 100 Hz and a phase duration of 350 microseconds. The electrical activity (recruitment of muscle fibers and maximum contraction) of the SHBF and LHBF and the muscle strength of the knee flexors were recorded by requesting the participants isometric flexion of the knee in the prone position. The percentage of change of each variable was also analyzed.
- Conditions
- Healthy
- Being tested
- Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromodulationOther
Ultrasound-guided percutaneous neuromodulation will be applied. The protocol used was 5 seconds of stimulation, 55 seconds of rest for 5 minutes at a frequency of 100 Hz and a phase duration of 350 microseconds
| Study group | Role | What they receive |
|---|---|---|
| Common fibular nerve group | Experimental | The subjects of this group will receive electric nerve stimulation on the sciatic nerve through a lateral approach to stimulate the behavior corresponding to the common fibular nerve Receives: Other: Neuromodulation |
| Tibial nerve group | Experimental | The subjects of this group will receive electric nerve stimulation on the sciatic nerve through a lateral approach to stimulate the behavior corresponding to the tibial nerve Receives: Other: Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical muscular activity
recruitment of muscle fibers, measured by electromyography (microvolts)
Measured: 3 months
muscle strength of the knee flexors
strength measured by dynamometer (Kg)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Dec 2022
- Primary completion2 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca de la Cruz Torres, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549700
- Sponsor's protocol ID
- Sciatic nerve and NMP
- Status last verified
- Dec 2022
- First submitted
- 15 Sep 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paez-Rodriguez J, Olivo-Ruiz I, Romero-Morales C, De-la-Cruz-Torres B. The fascicular anatomy of the sciatic nerve may not influence the muscular activity of the biceps femoris after applying percutaneous electrical nerve stimulation: a randomized clinical trial. Acupunct Med. 2024 Dec;42(6):326-333. doi: 10.1177/09645284241300176. Epub 2024 Nov 21.
PubMed 39569806
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fascicular Anatomy of Nerve May Influence the Muscular Activity of the Biceps Femoris After Applying Ultrasound-guided Percutaneous Neuromodulation
- ClinicalTrials.gov ID
- NCT05549700
- Acronym / sponsor ID
- Sciatic nerve and NMP
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 Sep 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.
The objective of this study will be to analyze the muscle activity of the short head (SHBF) and long head of the biceps femoris (LHBF) after the application of ultrasound-guided percutaneous neuromodulation (NMP) in the tibial or common fibular nerve compartment of the sciatic nerve.
Authors will recruit healthy subjects and they will receive asymmetric biphasic rectangular current through a needle into the sciatic nerve. The sample was divided into two groups: one to which the technique was applied in the lateral compartment and another group, in the medial compartment of the nerve. The protocol used was 5 seconds of stimulation, 55 seconds of rest for 5 minutes at a frequency of 100 Hz and a phase duration of 350 microseconds. The electrical activity (recruitment of muscle fibers and maximum contraction) of the SHBF and LHBF and the muscle strength of the knee flexors were recorded by requesting the participants isometric flexion of the knee in the prone position. The percentage of change of each variable was also analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common fibular nerve group | Experimental | Other: NeuromodulationThe subjects of this group will receive electric nerve stimulation on the sciatic nerve through a lateral approach to stimulate the behavior corresponding to the common fibular nerve |
| Tibial nerve group | Experimental | Other: NeuromodulationThe subjects of this group will receive electric nerve stimulation on the sciatic nerve through a lateral approach to stimulate the behavior corresponding to the tibial nerve |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (7 listed)
- Subjects that have lumbar area of the back, scoliosis, lower limb dysmetria
- Subjects undergone any surgical intervention in the lumbar area or lower limbs
- Subjects that present acute or unresolved injury in the last 6 months in the lower limbs
- Subjects under treatment drug treatment
- Subjects that they are afraid of needles or electric current
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 |
|---|---|---|
| NeuromodulationUltrasound-guided percutaneous neuromodulation will be applied. The protocol used was 5 seconds of stimulation, 55 seconds of rest for 5 minutes at a frequency of 100 Hz and a phase duration of 350 microseconds | Other | Common fibular nerve group, Tibial nerve group |
Primary outcome
Electrical muscular activity
Time frame: 3 months
recruitment of muscle fibers, measured by electromyography (microvolts)
muscle strength of the knee flexors
Time frame: 3 months
strength measured by dynamometer (Kg)
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 4 Jan 2023.
- Derived from this study: PubMed 39569806Paez-Rodriguez J, Olivo-Ruiz I, Romero-Morales C, De-la-Cruz-Torres B. The fascicular anatomy of the sciatic nerve may not influence the muscular activity of the biceps femoris after applying percutaneous electrical nerve stimulation: a randomized clinical trial. Acupunct Med. 2024 Dec;42(6):326-333. doi: 10.1177/09645284241300176. Epub 2024 Nov 21.
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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 Neuromodulation in people with Healthy, run by University of Seville 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 1 inclusion and 7 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 4 Jan 2023. 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?
Electrical muscular activity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549700, which also lists 1 linked publication.
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 4 Jan 2023.