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Clinical Trials/NCT07129096
NCT07129096Enrolling By InvitationNot Applicable

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

University of Oulu1 site in 1 country124 target enrollmentStarted: January 8, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
124
Locations
1
Primary Endpoint
TMD pain-related intensity

Study Overview

Brief 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.

Detailed Description

Background and significance More than 30% of people worldwide suffer from chronic pain, which causes human suffering for the individual and burdens the society financially. Musculoskeletal diseases are the most functionally impairing diseases in Europe. Masticatory muscle/jaw joint pains and dysfunctions (temporomandibular disorders, TMD) located in the face and head area are the second most common musculoskeletal pain conditions after low back pain. Various biopsychosocial risk factors, such as stress, depressive symptoms, anxiety, and sleep problems are related to chronic pain, including TMD pain. On the other hand, treating sleep disorders can also alleviate pain. Psychological stress and disturbances in the regulation of the pain mechanism related to chronic pain can manifest as dysfunction in the autonomic nervous system (ANS) activity. Compared to healthy people, TMD patients have impaired response of the ANS activity as indicated by higher heart rate, lower heart rate variability and lower baroreflex. Oral prafunctions, such as awake bruxism (tooth clenching during awakefulness) are also common in individuals with TMD and may share common psychosocial background factors with TMD, such as somatic symptoms, depression and anxiety.

Treatment of TMD aims to relieve pain and improve function. Usual treatment methods are counselling and guidance, muscle exercises, manual therapy, and occlusal splint therapy. Motivation and activation of the patient instead of the patient "receiving" passive treatment is important. Structured self-care methods should also be developed and evaluated considering cost-effectiveness. The Current Care Guidelines of pain emphasize the use of patient's own coping strategies. Relaxation training is mentioned as one of these methods, in addition to information, cognitive coping methods, and physical exercises.

Applied relaxation (AR) is a self-management method developed on the basis of Jacobson's progressive relaxation. The method is based on step-by-step training during a six-week programme where the person gradually learns the skill of relaxing his/her body in about 30 seconds. Learning this skill can be compared, for example, to learning to ride a bicycle, where the skill eventually becomes automatic.

AR has been used in treatment of various psychological and somatic conditions, such as anxiety disorders, panic disorders, dental fear, stress problems, gynaecological pain problems, tinnitus, musculoskeletal pains, as well as TMD symptoms, based on a previous randomised controlled trial. As a method that activates the patient and is easy to use independently, AR has several advantages compared to other coping or imagination-based methods. The patient is guided to control his/her reactions and sensations of the ANS by relaxing the body and/or muscle groups. The time needed for relaxation gradually decreases from 20 minutes to less than a minute and transforms from conscious to unconscious through active practice. This method is generally used in the treatment of chronic pain, mostly in specialised medical care units in group meetings under the guidance of a health care professional. There is a need for digital technology for training of AR, which could target it at a wider group of patients.

For training of AR a web application, named Relappy, was developed in University of Oulu and Oulu University Hospital in company collaboration as well as using the expertise on the field of psychology. The Relappy contains instructions, self-instructed exercises and exercise diaries for independent training of AR.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •presence of TMD pain diagnosis (myalgia, myofascial pain with referral, arthralgia and/or headache attributed to TMD), based on validated, international Diagnostic Criteria for TMD Axis I criteria
  • •the patient has a full dentition (lack of a single tooth in a balanced occlusion does not preclude participation)

Exclusion Criteria

  • •serious general illnesses such as rheumatism, schizophrenia or other serious mental illness
  • •pregnancy

Arms & Interventions

Applied relaxation treatment

Experimental

web-based training for applied relaxation

Intervention: Applied Relaxation (Behavioral)

Occlusal splint

Active Comparator

Occlusal splint treatment (traditional treatment)

Intervention: Occlusal splint (Device)

Outcomes

Primary Outcomes

TMD pain-related intensity

Time Frame: from baseline until 1 year from baseline

The patient fill in a webropol-based questionnaire on Graded Chronic Pain Scale (GCPS2.0) included in the validated Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The data is collected at baseline and at the 6-week, 3-month and 1-year follow-up points (after beginning the treatment). Mean pain-related intensity is mean of current, worst and average intensity of pain (on a scale from 0 (no pain) to 10 (worst pain).

TMD pain-related interference

Time Frame: from baseline until 1 year from baseline

The patient fill in a webropol-based questionnaire on Graded Chronic Pain Scale (GCPS2.0) included in the validated Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The data is collected at baseline and at the 6-week, 3-month and 1-year follow-up points (after beginning the treatment). The mean pain-related interference (during preceding 30 days) is calculated as mean of interference on daily activities, social activities and ability to work, using a scale from 0 (no interference) to 10 (unable to carry on any activities).

Secondary Outcomes

  • Body pain symptoms(From baseline until 1 year after baseline)
  • Depression symptoms(from baseline until 1 year after baseline)
  • Physical symptoms(from baseline until 1 year after baseline)
  • Anxiety symptoms(from baseline until 1 year after baseline)
  • Sleep quality(from baseline until 1 year after baseline)
  • Sleep diary(from baseline until 1 year after baseline)
  • Heart rate variability(from baseline until 1 year after baseline)
  • Baroreflex sensitivity (BRS)(from baseline until 1 year after baseline)
  • Body composition (Inbody)(from baseline until 1 year after baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kirsi Sipilä

Professor

University of Oulu

Study Sites (1)

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