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Not yet recruiting NCT07095101

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

No phase Interventional Temporomandibular Joint Disorder Temporomandibular Disorders (TMDs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobistudy Application, Occlusal splint.
Who it may be relevant to
Registry conditions: Temporomandibular Joint Disorder, Temporomandibular Disorders (TMDs). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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.

Interventions

  • Behavioral Mobistudy Application
    Treatment with mobile application
  • Device Occlusal splint
    Treatment with an occlusal splint

Primary outcome measures

  • Change in pain intensity [Time frame: From enrolment to 3 month follow-up]
Secondary outcome measures (4)
  • Cost-effectiveness [Time frame: From enrolment to 3 month follow-up]
  • Stress-levels [Time frame: From enrolment to 3 month follow-up]
  • Changes in general well-being [Time frame: From enrolment to 3 month follow-up]
  • Correlation between pain and overload [Time frame: From enrolment to 3 month follow-up]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Stanisic N, Do CT, Skarping S, Chrcanovic B, Bracci A, Manfredini D, Haggman-Henrikson B. Smartphone application to report awake bruxism: Development and testing of the Swedish version and a pilot study to evaluate family history in young adults and their parents. J Oral Rehabil. 2024 Jan;51(1):188-195. doi: 10.1111/joor.13515. Epub 2023 May 29. PMID 37210658
  • Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28. PMID 19646331
  • Haggman-Henrikson B, Liv P, Ilgunas A, Visscher CM, Lobbezoo F, Durham J, Lovgren A. Increasing gender differences in the prevalence and chronification of orofacial pain in the population. Pain. 2020 Aug;161(8):1768-1775. doi: 10.1097/j.pain.0000000000001872. Epub 2020 Mar 16. PMID 32701837
  • Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10. PMID 16095934

Identifiers

NCT: NCT07095101 · Dnr 2024-05598-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗