NCT05549700

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

1 day

First QC Date

September 15, 2022

Last Update Submit

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

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

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

Other: Neuromodulation

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

Common fibular nerve groupTibial nerve group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

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

Locations