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

NCT02320838 | Completed Results

• 1 other identifier: javendano
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain

Keywords

Transcutaneous Electric Nerve Stimulation; Electric Stimulation Therapy; Unmodulated Alternating Currents; Neural Conduction; Pain Threshold

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

• 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.

• 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.

Secondary Outcomes (16)

• Habituation to Electrical Stimulation

  Start treatment session (1 min), end treatment session (20 min)

• Perception Current Comfortability

  At the end of the third experimental session, 3 days

• Change Current Density (mA/cm2)

  at 1 min. treatment session, at 20 min. treatment session

• Change From Baseline in Nerve Conduction Amplitude ( µV)

  Baseline,immediately after treatment at 20 min..

• Baseline Mechanical Pain Threshold

  Baseline at 0 min.

Other Outcomes (1)

• Skin Temperature

  Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment

Study Arms (3)

5 KHz

EXPERIMENTAL

Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.

Device: 5 KHz

TENS

EXPERIMENTAL

Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds

Device: TENS

Sham Stimulation

SHAM COMPARATOR

Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.

Device: Sham stimulation

Interventions

5 KHz DEVICE

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

5 KHz

TENS DEVICE

TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

TENS

Sham stimulation DEVICE

Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Hospital Nacional de Parapléjicos de Toledo: collaborator

Related Publications (1)

• Avendano-Coy J, Gomez-Soriano J, Goicoechea-Garcia C, Basco-Lopez JA, Taylor J. Effect of Unmodulated 5-kHz Alternating Currents Versus Transcutaneous Electrical Nerve Stimulation on Mechanical and Thermal Pain, Tactile Threshold, and Peripheral Nerve Conduction: A Double-Blind, Placebo-Controlled Crossover Trial. Arch Phys Med Rehabil. 2017 May;98(5):888-895. doi: 10.1016/j.apmr.2016.11.020. Epub 2016 Dec 23.

  PMID: 28017706 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Juan Avendaño Coy
• Organization: Universidad de Castilla-La Mancha

juan.avendano@uclm.es

+34 925268800

Study Officials

• Juan Avendaño-Coy, MsC

  University of Castilla-La Mancha, Toledo, Spain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: December 19, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-07