Chronic PainNCT04236570
Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation
A study testing Thermode(hot plate) and cold water bath and TENS(transcutaneous electrical nerve stimulation) in people with Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Thermode(hot plate) and cold water bath and TENS(transcutaneous electrical nerve stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2020to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman between 18 and 60 years old (inclusive)
Who cannot join
- Chronic pain
- Neurological disorders
- Musculoskeletal disorders
- Depression
- Raynaud syndrome
- History of non-efficacy with TENS
Show all 12Show fewer
- History of epilepsy
- Presence of a pacemaker or metal implants
- Antidepressant
- Anticonvulsant
- Analgesics
- Caffeine
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Thermode(hot plate) and cold water bath, TENS(transcutaneous electrical nerve stimulation)
- Keywords
- Excitatory mechanisms, Inhibitory mechanisms, Thermode(hot plate), Cold water bath, Transcutaneous electrical nerve stimulation (TENS)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermode(hot plate) and cold water bathDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Pain tests with the standardized protocol | Other | 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. Receives: Device: Thermode(hot plate) and cold water bath |
| Pain tests with the TENS protocol | Other | 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 Receives: Device: TENS(transcutaneous electrical nerve stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: This outcome (mechanisms) will be evaluated at both sessions (V1 [day 0] and V2 [day 7])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start15 Jan 2020
- Primary completion15 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Léonard, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236570
- Sponsor's protocol ID
- 2019-3022
- Status last verified
- Feb 2021
- First submitted
- 7 Jan 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation (TENS)
- ClinicalTrials.gov ID
- NCT04236570
- Acronym / sponsor ID
- 2019-3022
- Conditions
- Chronic Pain
- Keywords
- Excitatory mechanisms, Inhibitory mechanisms, Thermode(hot plate), Cold water bath, Transcutaneous electrical nerve stimulation (TENS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pain tests with the standardized protocol | Other | Device: Thermode(hot plate) and cold water bathThis 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. |
| Pain tests with the TENS protocol | Other | Device: TENS(transcutaneous electrical nerve stimulation)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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Man or woman between 18 and 60 years old (inclusive)
Key exclusion criteria (12 listed)
- Chronic pain
- Neurological disorders
- Musculoskeletal disorders
- Depression
- Raynaud syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermode(hot plate) and cold water bathStandardized protocol will consisted of stimulus test (TS) generated by thermode and conditioning stimulus (CS) using cold water bath. | Device | Pain tests with the standardized protocol |
| TENS(transcutaneous electrical nerve stimulation)TENS protocol will consisted of test stimulus (TS) and conditioning stimulus (CS) both generated by TENS | Device | Pain tests with the TENS protocol |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermode(hot plate) and cold water bath and TENS(transcutaneous electrical nerve stimulation) in people with Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.