Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction

Pain Clinical Trial

Official title:

Unmodulated 5 Kilohertz Alternating Currents Versus TENS: Effect on Mechanical and Thermal Pain Thresholds, Tactile Threshold, and Peripheral Nerve Conduction in Humans.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320838
• Other study ID #: javendano
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: March 3, 2016
• Start date: November 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2014
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación ClínicaSpain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the transcutaneous application of unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover evidence whether the effect and comfort of this current is greater than Conventional TENS (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical pain.

Description:

In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents)

This evidences in animals could have application in pain treatment, characterized by overactive nervous system. For this reason it was decided to compare the effects on experimental pain and peripheral nerve conduction of this new electric current versus sham stimulation and TENS (Transcutaneous Electrical Nerve Stimulation).

The scientific literature on transcutaneous electrical stimulation in humans and changes in nerve conduction and / or somatosensory thresholds focuses mainly on TENS (Transcutaneous Electrical Nerve Stimulation). Therefore TENS is a good reference standard to compare the effect of this new currents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

• Neuromuscular disease.

• Epilepsy.

• Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.

• Osteosynthesis material in the upper limb.

• Diabetes.

• Cancer.

• Cardiovascular disease.

• Pacemaker or other implanted electrical device.

• Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.

• Presence of tattoos or other external agent introduced into the treatment or assessment area.

• Pregnancy.

• Sensitivity disturbance in upper limb.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• 5 KHz
5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
• TENS
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
• Sham stimulation
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Hospital Nacional de Parapléjicos de Toledo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	skin temperature	Skin temperature (ºC) will be recorded in all assessment times.	Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment	Yes
Primary	Mechanical pain threshold during treatment	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton	during treatment at 15 min	Yes
Primary	Thermal pain threshold during treatment	The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC	during treatment at 15 min.	Yes
Primary	Nerve conduction latency immediately after treatment	The compound action potential latencies will be measured and will be expressed in ms.	immediately after treatment at 20 min.	Yes
Primary	Tactile threshold during treatment	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	during treatment at 15 min.	Yes
Secondary	Habituation to electrical stimulation	The habituation to electrical stimulation along experimental session will be measured by recording current intensity (mA) at the start of the treatment session (1 min) and end of the same (20 min)	Start treatment session (1 min), end treatment session (20 min)	Yes
Secondary	Perception current comfortability (current treatment that has found more comfortable)	Participants will choose the current treatment that has found more comfortable	At the end of the third experimental session, 3 days	Yes
Secondary	Change current density (mA/cm2)	Current density (mA/cm2) will be recorded at 1 min. start of the treatment session and at 20 min of the same.	at 1 min. treatment session, at 20 min. treatment session	Yes
Secondary	Change from baseline in nerve conduction amplitude ( µV)	The compound action potential amplitudes ( µV) will be measured.	Baseline,immediately after treatment at 20 min..	Yes
Secondary	Baseline mechanical pain threshold	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton	Baseline at 0 min.	Yes
Secondary	Mechanical pain threshold post-treatment 20 min.	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton	at 20 min. post-treatment	Yes
Secondary	Mechanical pain threshold post-treatment 40 min.	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.	at 40 min. post-treatment	Yes
Secondary	Baseline thermal pain threshold	The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC	Baseline at 0 min.	Yes
Secondary	Thermal pain threshold post-treatment 20 min.	The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC	at 20 min. post-treatment	Yes
Secondary	Thermal pain threshold post-treatment 40 min.	The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC	at 40 min. post-treatment	Yes
Secondary	Baseline nerve conduction latency	The compound action potential latencies will be measured and will be expressed in ms.	Baseline at 0 min.	Yes
Secondary	Nerve conduction latency post-treatment 20 min.	The compound action potential latencies will be measured and will be expressed in ms.	at 20 min. post-treatment	Yes
Secondary	Nerve conduction latency post-treatment 40 min.	The compound action potential latencies will be measured and will be expressed in ms.	at 40 min. post-treatment	Yes
Secondary	Baseline tactile threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	Baseline at 0 min.	Yes
Secondary	Tactile threshold post-treatment 20 min.	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	at 20 min. post-treatment	Yes
Secondary	Tactile threshold post-treatment 40 min.	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	at 40 min. post-treatment	Yes