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

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: Healthy
• Intervention / Treatment: Other: Neuromodulation

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	recruitment of muscle fibers, measured by electromyography (microvolts)	3 months
muscle strength of the knee flexors	strength measured by dynamometer (Kg)	3 months

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

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