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临床试验/NCT07526688
NCT07526688尚未招募不适用

Aerobic Physical Activity and Orofacial Myofascial Pain

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Pain facilitation profile : masseter muscle

研究概览

简要总结

Orofacial myofascial pain, most commonly represented by Temporomandibular Disorders (TMD) a significant public health, affecting approximately 12% to 14% of the general population. These disorders are characterized by musculoskeletal pain in the masticatory muscles and joints, leading to reduced productivity and high socio-economic costs. Pathophysiological mechanisms are largely central in origin, similar to other chronic pain syndromes like fibromyalgia. Beyond pain, TMD severely impacts oral health-related quality of life by disrupting vital functions such as mastication and swallowing, and is frequently associated with accelerated dental structure loss due to clenching or grinding. While aerobic exercise is a recommended frontline treatment for many chronic pain conditions due to its ability to induce short-term hypoalgesia and long-term neuroplastic adaptations, it remains critically underutilized in the management of orofacial pain.

This controlled clinical study aims to compare a pain neuromodulation mechanism (Temporal Summation of Pain) among patients suffering from chronic orofacial myofascial pain, inactive healthy individuals, and healthy individuals practicing endurance sports.

Furthermore, investigating Endogenous Pain Modulation (EPM) in pain-free populations allows for a better understanding of how physical activity modulates pain pathways by eliminating confounding factors associated with pre-existing painful conditions.

This knowledge will help clarify how aerobic exercise can be utilized within preventive and therapeutic strategies for the management of orofacial myofascial pain. Moreover, it will facilitate the identification of efficacy markers for therapies such as exercise rehabilitation and physical activity.

详细描述

Participants will attend a single assessment session. During this session, temporal summation will be assessed, and participants will complete a set of standardized psychosocial and clinical questionnaires evaluating anxiety, depressive symptoms, sleep, daily physical activity, and sedentary behavior. Cardiovascular parameters will also be recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all participants:
  • Must be of legal age (18 years or older).
  • Must be fully informed of the study constraints and have provided written informed consent.
  • Must be registered with a social security scheme.
  • TMD-M Group (Orofacial Myofascial Pain):
  • Diagnosis of painful Temporomandibular Disorder (TMD) according to the DC/TMD (Diagnostic Criteria for TMD) clinical standards.
  • Athletic Group (Active Healthy Subjects):
  • Engagement in a minimum of 3 hours of endurance training per week. This threshold is set in accordance with evidence-based WHO recommendations for adults, stating that at least 30 minutes of regular moderate-intensity physical activity per day reduces the risk of multiple diseases.
  • Control Group (Inactive Healthy Subjects) :
  • Absence of TMD.
  • Absence of regular aerobic physical activity.

排除标准

  • Presence of chronic pain outside of TMD (temporomandibular joint disorder)
  • Patient under legal guardianship (guardianship, conservatorship)
  • Refusal to participate
  • Uncooperative patients, who do not speak or read French fluently, are unable to understand the principle of a pain scale, and are unable to cooperate with the tests.
  • Pregnant women

研究组 & 干预措施

Evaluation of the chronic orofacial pain

Other

All participants will follow the same procedure, which consists of completing several validated, standardized questionnaires. These questionnaires assess various psychological and emotional aspects, including anxiety (GAD-7) and depressive symptoms (PHQ-4), physical activity (IPAQ) and daytime sleepiness (Epworth Sleepiness Scale). Additionally, cardiovascular parameters will be collected.

干预措施: Temporal Summation of Pain and Questionnaire (Other)

结局指标

主要结局

Pain facilitation profile : masseter muscle

时间窗: Inclusion

ΔTSP : Comparison of the Temporal Summation of Pain score (10th stimulation score minus 1st stimulation score) at the masseter muscle using calibrated pinprick stimuli (calibrated to induce a baseline pain of 20/100) between the 3 groups (TDM ; control group and sports group).

次要结局

  • Temporal summation at the forearm muscle(Inclusion)
  • Referred sensations at the Masseter muscle(Inclusion)
  • Anxiety assessment(Inclusion)
  • Depression assessment(Inclusion)
  • Assessment of physical activity and sedentary behavior: IPAQ short form(Inclusion)
  • Daytime Sleepiness Assessment(Inclusion)
  • Evaluation of Cardiovascular parameters(Inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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