The Application of Neuromodulation in Sciatic Nerve

Sponsor

University of Seville (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05549700

Collaborator

(none)

Enrollment

Location

Arms

1.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Neuromodulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

The Fascicular Anatomy of Nerve May Influence the Muscular Activity of the Biceps Femoris After Applying Ultrasound-guided Percutaneous Neuromodulation

Anticipated Study Start Date :

Sep 27, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Common fibular nerve group 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	Other: Neuromodulation 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
Experimental: Tibial nerve group 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	Other: Neuromodulation 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

Arm

Intervention/Treatment

Experimental: Common fibular nerve group

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

Other: Neuromodulation

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

Experimental: Tibial nerve group

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

Other: Neuromodulation

Outcome Measures

Primary Outcome Measures

Electrical muscular activity [3 months]
recruitment of muscle fibers, measured by electromyography (microvolts)
muscle strength of the knee flexors [3 months]
strength measured by dynamometer (Kg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteer

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blanca	Seville	Sevile	Spain	41009

Sponsors and Collaborators

University of Seville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Blanca de la Cruz Torres, Director, University of Seville

ClinicalTrials.gov Identifier:

NCT05549700

Other Study ID Numbers:

Sciatic nerve and NMP

First Posted:

Sep 22, 2022

Last Update Posted:

Sep 22, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 22, 2022