Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation

Sponsor
Université de Sherbrooke (Other)
Overall Status
Completed
CT.gov ID
NCT04236570
Collaborator
(none)
50
1
2
7.6
6.6

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Thermode(hot plate) and cold water bath
  • Device: TENS(transcutaneous electrical nerve stimulation)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will attended two experimental sessions at the Research Center on Aging of the Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie, Sherbrooke, during which the efficacy of their excitatory and inhibitory mechanisms was assessed. In one session, this assessment was done using TENS protocol; in the other, using a standardized protocol (thermode and cold water bath). Session order was randomized between participants (randomization by block of 4 stratified by sex, using a random number table). The two sessions were separated by 24 to 72 hours and lasted approximately one hour each.Participants will attended two experimental sessions at the Research Center on Aging of the Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie, Sherbrooke, during which the efficacy of their excitatory and inhibitory mechanisms was assessed. In one session, this assessment was done using TENS protocol; in the other, using a standardized protocol (thermode and cold water bath). Session order was randomized between participants (randomization by block of 4 stratified by sex, using a random number table). The two sessions were separated by 24 to 72 hours and lasted approximately one hour each.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation (TENS)
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
Aug 15, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate excitatory mechanisms, specifically temporal summation [This outcomes (excitatory pain mechanisms) will be evaluated at both sessions (V1 [day 0] and V2 [day 7])]

    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)

  2. Evaluate inhibitory mechanisms, specifically conditioning pain modulation (CPM) [This outcome (mechanisms) will be evaluated at both sessions (V1 [day 0] and V2 [day 7])]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre de Recherche sur le Vieillissement Sherbrooke Quebec Canada J1H 4C4

Sponsors and Collaborators

  • Université de Sherbrooke

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guillaume Léonard, Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT04236570
Other Study ID Numbers:
  • 2019-3022
First Posted:
Jan 22, 2020
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guillaume Léonard, Professor, Université de Sherbrooke
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021