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ENROLLING BY INVITATION
NCT07129096
NA

Digitally Trained Applied Relaxation for Treatment of Temporomandibular Pain

Sponsor: University of Oulu

View on ClinicalTrials.gov

Summary

Temporomandibular disorders (TMD) are common musculoskeletal pain conditions related to masticatory muscles and temporomandibular joints. Applied relaxation (AR) is a self-management method widely used and tested for treatment of various psychological and somatic conditions, including musculoskeletal pain and other chronic pain conditions. AR is trained step-by-step on a 6-week program under guidance of health care professional. For training of AR, a web application (Relappy) has been developed in University of Oulu, Finland. The aim of the project is to test the Relappy for training of AR. At first, Relappy is tested by volunteers (n=26). The randomized controlled trial on TMD patients evaluates the effectiveness of web application-based AR training on TMD pain symptoms, psychosocial burden, sleep quality and autonomic nervous system (ANS) activity. The study sample includes TMD patients (n=124) from Finnish Student Health Service in Oulu and Turku units. They are randomly assigned to 2 treatment groups: AR group (trained by AR web application) and stabilization splint group (traditional treatment). TMD pain, body pain, psychosocial symptoms and sleep problems are assessed with validated questionnaires at baseline and at 6-week, 3- month and 1-year follow-up points. The patients also use a digital sleep diary application. Additionally, ANS activity is measured from patients in Oulu before treatment and 3 months weeks and 1 year after baseline. In the analyses, the variables are compared between treatment groups. The present project also includes preparing of the commercialization, aiming to develop the Relappy for wider target groups of pain patients and public use, regardless of time and place of use. The project has many societal and economic impacts. It can be expected that when actively trained, web application for AR will offer a cost-efficient self-management method to relieve TMD pain, body pain, and other stress-related symptoms and thus improve general well-being. It is expected to reduce healthcare costs and treatment burden and promote sustainability.

Official title: Treatment of Temporomandibular Pain and Disorders With Applied Relaxation Trained Using a Web Application- a Randomized Controlled Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-01-08

Completion Date

2030-12-31

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

Applied Relaxation

Applied relaxation method developed by psychologists from progressive relaxation is used. The method is trained using a web application (Relappy.app), which contains step-by-step instructions with self-instructed exercises and exercise diaries, in which the examinee records his/her level of tension before and after the exercise (on a scale of 0-100, where 0 means a completely relaxed state, 50 a normal state (neither relaxed nor tense) and 100 maximum tenseness.

DEVICE

Occlusal splint

The splint group is treated with occlusal splint, which is a conventional treatment method in cases where the implementation of information and self-care methods has not given a sufficient treatment response. The splint is prepared for night use and controlled according to the usual protocol.

Locations (1)

University of Oulu

Oulu, Finland