The Application of Neuromodulation in Sciatic Nerve
The Fascicular Anatomy of Nerve May Influence the Muscular Activity of the Biceps Femoris After Applying Ultrasound-guided Percutaneous Neuromodulation
1 other identifier
interventional
38
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Dec 2022
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJanuary 4, 2023
December 1, 2022
1 day
September 15, 2022
December 31, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Electrical muscular activity
recruitment of muscle fibers, measured by electromyography (microvolts)
3 months
muscle strength of the knee flexors
strength measured by dynamometer (Kg)
3 months
Study Arms (2)
Common fibular nerve group
EXPERIMENTALThe 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
EXPERIMENTALThe 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Healthy volunteer
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blanca
Seville, Sevile, 41009, Spain
Related Publications (1)
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.
PMID: 39569806DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 22, 2022
Study Start
December 1, 2022
Primary Completion
December 2, 2022
Study Completion
December 30, 2022
Last Updated
January 4, 2023
Record last verified: 2022-12