Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation

Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation (TENS)

A number of chronic pain conditions are characterized by imbalances in excitatory and/or inhibitory mechanisms and these deficits appear correlated with the response to certain treatments. Evaluating these mechanisms among people who suffer from chronic pain could allow clinicians to adapt the treatment to each patient according to the deficits observed. To evaluate excitatory and inhibitory mechanisms, a thermode (hot plate) and a cold water bath can be used (standardized protocol). Unfortunately, these tools are expensive, time-consuming and require complex equipment and software. As such, it is not realistic for clinicians to use them for routine patient assessment. A potential alternative to study these mechanisms is TENS (transcutaneous electrical nerve stimulation). TENS is frequently used in rehabilitation and unlike thermode and cold water bath, is affordable, easy to use and requires very little time and equipment. The objective of this study are to determine if the TENS can replace the thermode and cold water bath (standardized protocol) for the evaluation of excitatory and inhibitory mechanisms. Also, to determine if there will be a correlation with the standardized protocol. 50 healthy participants between 18 and 60 years old will participate in this study. Each participant will attend two experimental sessions. In one of the two sessions, the evaluation will be done with the TENS; in the other session, the evaluation will be done with the standardized protocol (thermode and cold water bath).

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Thermode(hot plate) and cold water bath; Device: TENS(transcutaneous electrical nerve stimulation)

Detailed Description

To evaluate excitatory and inhibitory mechanisms, the investigators will used the modified CPM testing procedure consisting of test stimulus (TS) administered before and after a conditioning stimulus (CS). For the standardized protocol, the TS will consisted of a noxius heat stimulus generated by a thermode (hot plate), applied for two minutes on the non-dominant anterior forearm. The CS will consisted of a cold pressor test (CT), wherein participants immersed their dominant forearm in a cold water bath for two minutes. For the TENS protocol, the TS will consisted of a noxius electrical stimulus generated by TENS, applied for 5 seconds on the non-dominant knee at a frequency of 1 Hz and 5 Hz. The CS will consisted of a noxius electrical stimulus generated by TENS' applied for 120 seconds on the non dominant knee and ankle at a frequency of 2 Hz.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Centre de recherche sur le vieillissement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Man or woman between 18 and 60 years old (inclusive)

Exclusion Criteria:

• Chronic pain
• Neurological disorders
• Musculoskeletal disorders
• Depression
• Raynaud syndrome
• History of non-efficacy with TENS
• History of epilepsy
• Presence of a pacemaker or metal implants
• Antidepressant
• Anticonvulsant
• Analgesics
• Caffeine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Pain tests with the standardized protocol; This arm will consisted of pain tests using the standardized protocol (thermode(hot plate) and cold water bath)). The investigators will used the modified CPM testing procedure consisting of stimulus test (TS) administered before and after a conditioning stimulus (CS). For the standardized protocol, the TS will consisted of a noxius heat stimulus generated by a thermode (hot plate), applied for two minutes on the non-dominant anterior forearm. The CS will consisted of a cold pressor test (CT), wherein participants immersed their dominant forearm in a cold water bath for two minutes.	Device: Thermode(hot plate) and cold water bath; Standardized protocol will consisted of stimulus test (TS) generated by thermode and conditioning stimulus (CS) using cold water bath.
OTHER: Pain tests with the TENS protocol; This arm will consisted of pain tests using the TENS protocol. The investigators will used the modified CPM testing procedure consisting of stimulus test (TS) administered before and after a conditioning stimulus (CS). For the TENS protocol, the TS will consisted of a noxius electrical stimulus generated by TENS, applied for 5 seconds on the non-dominant knee at a frequency of 1 Hz and 5 Hz. The CS will consisted of a noxius electrical stimulus generated by TENS' applied for 120 seconds on the non dominant knee and ankle at a frequency of 2 Hz	Device: TENS(transcutaneous electrical nerve stimulation); TENS protocol will consisted of test stimulus (TS) and conditioning stimulus (CS) both generated by TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate excitatory mechanisms, specifically temporal summation	To evaluate excitatory mechanisms ,we will calculated if there is an increase of pain levels during the test stimulus (TS). Pain levels will be measured with a computerized visual analogue scale (CoVAS)	This outcomes (excitatory pain mechanisms) will be evaluated at both sessions (V1 [day 0] and V2 [day 7])
Evaluate inhibitory mechanisms, specifically conditioning pain modulation (CPM)	To evaluate inhibitory mechanisms ,we will calculated if there is an decrease of pain levels after the conditioning stimulus (CS). Pain levels will be measured with a computerized visual analogue scale (CoVAS)	This outcome (mechanisms) will be evaluated at both sessions (V1 [day 0] and V2 [day 7])

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2020
• Primary Completion (ACTUAL): August 15, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (ACTUAL): January 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 13, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Transcutaneous electrical nerve stimulation (TENS); Cold water bath; Excitatory mechanisms; Inhibitory mechanisms; Thermode(hot plate)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2019-3022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No