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 range18 Years – 50 Years
SexFEMALE
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
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.