Assessment of Generalized Alterations in Nociceptive Processing Among Patients Presenting With Temporo-mandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The extent of secondary hyperalgesia on the forearm in the proximo-distal direction 45 minutes after HFS
研究概览
简要总结
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.
详细描述
This control study is designed to compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms in individuals with chronic TMD (as a main complain) and in healthy controls.
During the first part of the experiment (time1, day 1), all potential participants will fill a basic demographic questionnaire concerning their age, weight, height, and current medications (appendix 2). Participants with TMD will be diagnosed according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The DC/TMD includes the following questionnaires: the Graded Chronic Pain Scale, the Jaw Functional Limitation scale, the Generalized Anxiety Disorder-7, the Patient Health Questionnaire-9 and -15 and the Oral Behaviors Checklist. In addition, participants will be asked to fill the Central sensitization inventory questionnaire, as well as the symptom Severity Scale. Lastly, the investigators will evaluate the distribution of pain by asking participants to draw the pain that they felt during the past 7 days on a digital tablet. This will allow us to determine the total area of pain of each participant, as well as the Widespread Pain Index. Subjects will also be asked to provide a rating of their average pain for the last 24h
The psychophysical evaluation will be conducted later on the same day (day1). Subjects will be asked to provide a rating of their average pain at present time (time 2). Then, participants will be familiarized with the different procedures involved in the experiment.
Pressure pain thresholds will be assessed on the temporalis muscle, the trapezius muscle, and tibialis anterior (time 3).
The intensity of pain resulting from pinprick stimulation and allodynia in the area surrounding the electrode ("test area") will be assessed, as well as on the homologous site of the contralateral control arm before HFS (time 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for healthy controls:
- •Females aged between 18 and 50 years.
- •BMI between 17 and
- •Ability to provide written informed consent.
排除标准
- •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
- •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
研究组 & 干预措施
Healthy control
干预措施: High-frequency electrical stimulation (Procedure)
Temporomandibular disorder
干预措施: High-frequency electrical stimulation (Procedure)
结局指标
主要结局
The extent of secondary hyperalgesia on the forearm in the proximo-distal direction 45 minutes after HFS
时间窗: 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.
The area of secondary hyperalgesia (cm square) will be assessed with a calibrated 128 millinewton pinprick probe. Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure
次要结局
- Oral Behaviors Checklist(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Weight(At baseline (time 1). This outcome is taken at day 1 at time 1.)
- Patient health questionnaire-9(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Patient health questionnaire-15(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Age(During the initial evaluation (time 1). This outcome is taken at day 1 at time 1.)
- Jaw functional limitation scale(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Generalized anxiety disorder-7(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Height(At baseline (time 1). This outcome is taken at day 1 at time 1.)
- The TMD diagnosis according to the diagnostic criteria for temporomandibular disorders (DC/TMD)(At baseline (time 1). This outcome is taken at day 1 at time 1.)
- Graded chronic pain scale(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Central sensitization inventory(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Average pain at present time before HFS: score(During the initial evaluation (time 2). This outcome is taken at day 1 at time 2.)
- Symptom severity scale(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- The distribution of pain(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- The Widespread pain index(At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.)
- Average pain during the last 24h before HFS(During the initial evaluation (time 1). This outcome is taken at day 1 at time 1.)
- Pressure pain thresholds on the temporalis muscle, trapezius muscle and tibialis anterior(During the initial evaluation (time 3)]. This outcome is taken at day 1 at time 3.)
- The long term persistence of secondary hyperalgesia after HFS(24 hours (time 8) and 48 hours after HFS (time 9). This outcome is taken at day 2 at time 8, and at day 3 at time 9.)
- Baseline pain resulting from pinprick stimulation in the area surrounding the electrode ("test area") and on the homologous site of the contralateral control arm(Just before HFS (time 4)]. This outcome is taken at day 1 at time 4.)
- Allodynia in the area surrounding the electrode ("test area") and on the homologous site of the contralateral control arm(Just before HFS (time 4) and after HFS (time 6). This outcome is taken at day 1 at time 4 and time 6.)
- The intensity of pain resulting from pinprick stimulation 30 min after HFS(Time Frame: At baseline (time 6). This outcome is taken at day 1 at time 6.)