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NCT Number: NCT04236570

Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation

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).

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermode(hot plate) and cold water bath

Device

Standardized protocol will consisted of stimulus test (TS) generated by thermode and conditioning stimulus (CS) using cold water bath.

TENS(transcutaneous electrical nerve stimulation)

Device

TENS protocol will consisted of test stimulus (TS) and conditioning stimulus (CS) both generated by TENS

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2020
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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