Assessment of Nociceptive Processing Among Patients With Temporo-mandibular Disorders (NCT04086732) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Nociceptive Processing Among Patients With Temporo-mandibular Disorders
Belgium40 participantsStarted 2021-01-11
Plain-language summary
This case control study will investigate the physiological effect of nociceptive input in individuals with temporomandibular disorders. To do so, the investigators will compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms for up to 48 hours in individuals with chronic TMD (as a main complain) and in healthy controls. Furthermore, the investigators will evaluate the association between the response to HFS and various factors, such as demographic, psychosocial and pain-related clinical factors.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for healthy controls:
* Females aged between 18 and 50 years.
* BMI between 17 and 30.
* Ability to provide written informed consent.
Exclusion Criteria for healthy controls:
* Evidence of psychiatric/inflammatory/neurological or metabolic comorbidities on direct questioning as this study is meant to focus on musculoskeletal disorders.
* Evidence of skin alteration on the volar forearms that may interfere with HFS.
* Any substance abuse, or the use of antidepressant or neuroleptic medication as these may interfere with the psychophysical examination.
* Any painful musculoskeletal disorder.
* Lack of dental check-ups during the last 12 months.
Inclusion Criteria for the TMD group:
* Females aged between 18 and 50 years.
* BMI between 17 and 30.
* Ability to provide written informed consent.
* Chronic TMD (for at least 3 months) as a main complain (according to the DC/TMD), with an average of at least 3/10 on a pain numerical rating scale during the past month in the orofacial region.
Exclusion Criteria for the TMD group:
* Evidence of psychiatric/inflammatory/neurological or metabolic comorbidities on direct questioning as this study is meant to focus on musculoskeletal disorders.
* Evidence of skin alteration on the volar forearms that may interfere with HFS.
* Any substance abuse, or the use of antidepressant or neuroleptic medication as these may interfere with the psychophysical examination.
* Lack of dental check-ups during the last 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The extent of secondary hyperalgesia on the forearm in the proximo-distal direction 45 minutes after HFS
Timeframe: After HFS and the assessment of pain resulting from pinprick stimulation and allodynia (time 7). This outcome is taken at day 1 at time 7.