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临床试验/NCT07095101
NCT07095101尚未招募不适用

Effect and Cost-effectiveness of Smartphone-based Behavioural Intervention on Orofacial Pain

Malmö University0 个研究点目标入组 120 人开始时间: 2025年8月22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
发起方
入组人数
120
主要终点
Change in pain intensity

研究概览

简要总结

Pain in the orofacial region has a 10% prevalence in the general population and health care providers are therefore expected to encounter these patients on a daily basis. Chronic orofacial pain often presents as jaw pain related to overload of the jaw muscles and temporomandibular joints. The aim of this study is to evaluate the effectiveness of a smartphone-based behavioural intervention (Ecological Momentary Intervention, EMI) grounded in Cognitive Behavioural Therapy (CBT), compared to standard treatment with an occlusal splint and a waiting list control group.

详细描述

The World Health Organization (WHO) emphasizes oral health as a key indicator of overall wellbeing. Poor oral health, especially when associated with pain, severely impacts individuals by reducing their quality of life. Orofacial pain is the third most common chronic pain, after knee and neck/back pain, and affects more than 10% of the adult population worldwide. In common with other chronic pain conditions, orofacial pain is a multi-factorial condition involving biological, psychological, and social factors - all encompassed in the biopsychosocial model. Contributing factors to pain, such as stress and anxiety are increasing, highlighting the need to identify and manage patients to counteract this growing problem. One potential risk factor for orofacial pain is muscle and joint overload due to stress-related tooth clenching and grinding. It is therefore important to evaluate and modify behaviours related to such overload.

Shortage of resources results in many patients not receiving treatment. In addition to the suffering experienced by affected individuals, chronic pain also significantly impacts family members, and leads to increased healthcare costs and a substantial societal burden.

Effective treatments, such as cognitive behavioural therapy (CBT), are available, but time-consuming, requiring repeated visits to care providers. Consequently, the incorporation of eHealth solutions utilizing mobile technology and internet-based therapy has been recommended. The implementation of eHealth, defined as "the use of information and communications technology in support of health and health-related fields" is advocated by the WHO to "accelerate global attainment of health and wellbeing". The recent development of smartphone and internet-based applications offers a promising avenue for cost-effectiveness and equity in health care

Traditional treatment of orofacial pain with oral splints requires repeated dental visits and incur significant costs together with additional technician costs for splint fabrication. A digital behavioural intervention could offer a drastically more cost-effective solution, reduce patients' suffering and the number of treatment visits, thereby easing the burden on the current waiting lists for patients with orofacial pain that in many regions can be a year or more. The project will investigate whether digital behavioural intervention can serve as a cost-effective alternative to traditional occlusal splint therapy for managing orofacial pain. By integrating real-time data collection and intervention, patients can be offered personalized, accessible treatment that seamlessly integrate into daily life. The availability of cost-effective eHealth solutions is especially relevant in regions with limited access to health care due to geographical distances or shortage of health care providers. Moreover, eHealth medical care can also be invaluable in situations for patients who are homebound for any reason.

This project aims to gain unique knowledge into the core mechanisms of pain and evaluate a novel multimodal person-centred eHealth approach for management of orofacial pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Chronic orofacial pain, duration ≥3 months with a diagnosis of Myalgia according to the brief DC/TMD.
  • •Patients will be included even if they have one or more additional DC/TMD diagnoses
  • •Regular smartphone users
  • •Understanding written and spoken Swedish
  • •Age ≥ 18 years

排除标准

  • •Other orofacial non-TMD pain conditions
  • •Cognitive impairment.

研究组 & 干预措施

Mobistudy Application

Experimental

Treatment with mobile application

干预措施: Mobistudy Application (Behavioral)

Occlusal splint

Active Comparator

Treatment with an occlusal splint

干预措施: Occlusal splint (Device)

Waiting list

No Intervention

Waiting list followed by delayed intervention with mobile application

结局指标

主要结局

Change in pain intensity

时间窗: From enrolment to 3 month follow-up

Pain level will be assessed using the Numeric rating Scale (NRS, a scale ranging from 0 (no pain) to 10 (worst pain imaginable). A 30% reduction in pain according to the NRS is considered a significant effect.

Change in pain intensity

时间窗: From enrolment to 3 month follow-up

Pain level will be assessed using the Numeric rating Scale (NRS, a scale ranging from 0 (no pain) to 10 (worst pain imaginable). A 30% reduction in pain according to the NRS is considered a significant effect.

次要结局

  • Cost-effectiveness(From enrolment to 3 month follow-up)
  • Cost-effectiveness(From enrolment to 3 month follow-up)
  • Stress-levels(From enrolment to 3 month follow-up)
  • Changes in general well-being(From enrolment to 3 month follow-up)
  • Correlation between pain and overload(From enrolment to 3 month follow-up)
  • Stress-levels(From enrolment to 3 month follow-up)
  • Changes in general well-being(From enrolment to 3 month follow-up)
  • Correlation between pain and overload(From enrolment to 3 month follow-up)

研究者

发起方
Malmö University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Birgitta Haggman Henriksson

Professor

Malmö University

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