ePROPP - eHealth for Preventing and Reducing Orofacial Pain in the Population

Malmö University

Status: Not yet enrolling

Conditions: Temporomandibular Disorders (TMDs); Temporomandibular Joint Disorder

Treatments: Device: Occlusal splint; Behavioral: Mobistudy Application

Study type: Interventional

Funder types: Other

Identifiers

NCT07095101

Dnr 2024-05598-01

Details and patient eligibility

About

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.

Full description

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.

The overarching goal is to develop and evaluate a cost-effective eHealth tool for management of orofacial pain in collaboration with health care providers, facilitating large scale implementation in the population. The non-inferiority hypothesis: Treatment with a smartphone based behavioural intervention is not inferior to treatment with occlusal splint.

The superiority hypothesis: Compared to waiting list, a smartphone based behavioural intervention can reduce orofacial pain.

The results from this project can enable a broad implementation of an eHealth treatment that conserves resources, helping to address the current resource shortages in healthcare.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Mobistudy Application

Experimental group

Description:

Treatment with mobile application

Treatment:

Behavioral: Mobistudy Application

Occlusal splint

Active Comparator group

Description:

Treatment with an occlusal splint

Treatment:

Device: Occlusal splint

Waiting list

No Intervention group

Description:

Waiting list followed by delayed intervention with mobile application