ePROPP - eHealth for Preventing and Reducing Orofacial Pain in the Population
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMalmö University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other orofacial non-TMD pain conditions
Cognitive impairment.
Trial design
Design model
Parallel
Treatments tested in this trial
Mobistudy Application
BehavioralTreatment with mobile application
Occlusal splint
DeviceTreatment with an occlusal splint
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Mobistudy ApplicationExperimental treatment 1 intervention
Group B: Occlusal splintActive comparator 1 intervention
Group C: Waiting listNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in pain intensity
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.
Time frame
From enrolment to 3 month follow-upSecondary outcomes
1
Cost-effectiveness
Cost-effectiveness will be assessed using direct and indirect costs to calculate total societal costs for the two different interventions
Time frame
From enrolment to 3 month follow-up2
Stress-levels
Assessment of stress will be done using the Perceived stress-scale (PSS-10) which yields a total score from 0 to 40, calculated by summing responses to 10 items, each scored on a 5-point Likert scale (0 = never to 4 = very often).
Time frame
From enrolment to 3 month follow-up3
Changes in general well-being
Assessment of general wellbeing will be done with Patient Health Questionnaire (PHQ-4) which combines two 2-item scales: the PHQ-2 (depression) and the GAD-2 (anxiety). Each question is scored on a 4-point Likert scale (0-3), and the total score is the sum of all four items Higher scores indicate a greater severity of symptoms.
Time frame
From enrolment to 3 month follow-up4
Correlation between pain and overload
During the first 3 days of using the mobistudy application, the relation between muscluskeletal overload and TMD-pain will be assessed.. Assessment of overload with Ecological momentary assessment of self-reported overload will be correlated (Spearman's correlated) to pain intensity using the Numeric rating Scale (NRS), a scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame
From enrolment to 3 month follow-upOther outcomes
1
Coping
Coping will be assessed with the Brief Resilience Coping Scale (BRCS-4) using a 5-point Likert scale for each item, ranging from "Does not describe me at all" to "Describes me very well". The total score is calculated by summing the responses to all four items. Higher scores indicate a greater tendency toward resilient coping.
Time frame
From enrolment to 3 month follow-up2
Headache
Assessment with the Headache screening questionnaire (HSQ). The HSQ aims to identify individuals who might have migraine or tension type headache by assessing headache characteristics across four domains: frequency, duration, characteristics, and symptoms.
Time frame
From enrolment to 3 month follow-up3
Widespread pain
Widespread pain will be assessed by a pain manikin.
Time frame
From enrolment to 3 month follow-upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Malmö University
Lead sponsor
Folktandvården Skåne AB
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: