Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation

Université de Sherbrooke

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Thermode(hot plate) and cold water bath; Device: TENS(transcutaneous electrical nerve stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT04236570

2019-3022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Pain tests with the standardized protocol

Other group

Description:

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.

Treatment:

Device: Thermode(hot plate) and cold water bath

Pain tests with the TENS protocol

Other group

Description:

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

Treatment:

Device: TENS(transcutaneous electrical nerve stimulation)