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Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation

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ClinicalTrials.gov Identifier: NCT04236570
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Guillaume Léonard, Université de Sherbrooke

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
Chronic Pain Device: Thermode(hot plate) and cold water bath Device: TENS(transcutaneous electrical nerve stimulation) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation (TENS)
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. Evaluate excitatory mechanisms, specifically temporal summation [ Time Frame: 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) [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236570


Contacts
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Contact: Guillaume Léonard, Pht; Ph.D 8197802220 ext 45246 guillaume.leonard2@usherbrooke.ca
Contact: Monica Sean, B.Sc 8197802220 ext 45681 monica.sean@usherbrooke.ca

Locations
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Canada, Quebec
Centre de Recherche sur le Vieillissement Recruiting
Sherbrooke, Quebec, Canada, J1H 4C4
Contact: Guillaume Léonard, Pht; Ph.D    8197802220 ext 45246    guillaume.leonard2@usherbrooke.ca   
Contact: Monica Sean, B.Sc    8197802220 ext 45681    monica.sean@usherbrooke.ca   
Principal Investigator: Guillaume Léonard, Pht; Ph.D         
Sponsors and Collaborators
Université de Sherbrooke

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Responsible Party: Guillaume Léonard, Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT04236570    
Other Study ID Numbers: 2019-3022
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guillaume Léonard, Université de Sherbrooke:
Excitatory mechanisms
Inhibitory mechanisms
Thermode(hot plate)
Cold water bath
Transcutaneous electrical nerve stimulation (TENS)
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms