The Application of Neuromodulation in Sciatic Nerve

December 31, 2022 updated by: Blanca de la Cruz Torres, University of Seville

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Sevile
      • Seville, Sevile, Spain, 41009
        • Blanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical muscular activity
Time Frame: 3 months
recruitment of muscle fibers, measured by electromyography (microvolts)
3 months
muscle strength of the knee flexors
Time Frame: 3 months
strength measured by dynamometer (Kg)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

December 2, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 31, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Sciatic nerve and NMP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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