Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes

Pain Clinical Trial

— TTE_PVV_1_36  

Official title:

Can Blood Flow Enhancing Plantar Flexion Electrically Induced Via Textile Electrodes in a Sock Using 1 Hz Frequency Give Better Comfort and Energy Efficiency as Compared to 36 Hz ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06082297
• Other study ID #: TTE_PVV_1_vs_36_Hz
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: August 13, 2019

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Muscle contractions induced by calf low-intensity neuromuscular electrical stimulation (C-LI-NMES) can increase venous return and may reduce venous thromboembolism. This study aimed to compare the effect of different C-LI-NMES frequencies and plateau times on hemodynamics, discomfort and energy efficiency, when applied via sock-integrated transverse textile electrodes.

Description:

Fifteen healthy participants were stimulated via two 3x3cm transverse textile electrodes integrated in a sock, with ten different combinations of frequency (1Hz or 36Hz) and plateau times (0.5/1.5/3/5/7s), with gradually increasing NMES-intensity until plantar flexion-induction. At this point, popliteal peak venous velocity (PVV), time-averaged mean velocity (TAMV) and ejection volume (EV) were assessed by Doppler-ultrasound, discomfort by a numerical rating scale (NRS, 0-10) and values for current amplitude and energy were calculated based on the NMES-device´s intensity level. Values expressed with median (interquartile range), significance set to p<0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age 18-99 years of age
• Voluntary participation

Exclusion Criteria:

• Pregnancy
• Pacemaker
• Ongoing thromboprophylaxis
• Skin wounds
• Vascular abnormalities
• Previous vascular system surgery in the lower limbs

Related Conditions & MeSH terms

• Hemodynamic Instability
• Pain

Intervention

Device:
• Chattanooga Physio, DJO, neuromuscular electrical stimulation
Neuromuscular electrical stimulation (NMES) was applied with a device called Chattanooga Physio (DJO), testing 10 different combinations of parameter-settings. The parameter-settings that were varied and combined were frequency (1Hz and 36Hz) and plateau times (0.5s, 1.5s, 3s, 5s, 7s). The NMES was applied to the calf of the participants via transversally placed textile electrodes (3x3 cm) integrated in a sock starting with very low current amplitude followed by gradual small increases in current amplitude until induction of ankle plantar flexion, at which time-point the outcomes where measured.

Locations

Country	Name	City	State
Sweden	Karolinska university Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak venous velocity (PVV)	Peak venous velocity (centimeters per second) will be assesed by Doppler ultrasound of in the popliteal vein	Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
Primary	Time averaged mean velocity (TAMV)	Time averaged mean velocity will be assesed by Doppler ultrasound in the popliteal vein (centimeters per second)	Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
Primary	Average duration of blood pulse (ADBP)	Average duration of blood pulse will be assesed by Doppler ultrasound in the popliteal vein (seconds)	Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
Primary	Ejection volume (EV)	Ejection volume of blood will be assesed by Doppler ultrasound in the popliteal vein (milliliters)	Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention
Secondary	Numerical rating scale (NRS)	Discomfort estimated using a numerical rating scale from 0 (no pain) to 10 (worst pain)	Day 1 during ankle plantar flexion was induced by the intervention
Secondary	Current amplitude	Current amplitude in milliampere (mA) will be assessed by using stepwise increases (typically 1mA) on the NMES device until a plantar flexion is induced	Day 1 during ankle plantar flexion was induced by the intervention
Secondary	Energy	Energy per stimulation cycle in millijoule (mJ) will be assessed by using stepwise increases (typically 1mA) on the NMES device until a plantar flexion is induced, at which point the energy consumption (mJ) is calculated.	Day 1 during ankle plantar flexion was induced by the intervention