Digitally Trained Applied Relaxation for Treatment of Temporomandibular Pain

NCT07129096 | Enrolling By Invitation

• 1 other identifier: 123
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders (TMD)

Keywords

randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• TMD pain-related intensity

  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).

  from baseline until 1 year from baseline

• TMD pain-related interference

  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).

  from baseline until 1 year from baseline

Secondary Outcomes (9)

• 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

Study Arms (2)

Applied relaxation treatment

EXPERIMENTAL

web-based training for applied relaxation

Behavioral: Applied Relaxation

Occlusal splint

ACTIVE COMPARATOR

Occlusal splint treatment (traditional treatment)

Device: Occlusal splint

Interventions

Applied Relaxation BEHAVIORAL

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.

Applied relaxation treatment

Occlusal splint DEVICE

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.

Occlusal splint

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Oulu: lead
• University of Eastern Finland: collaborator
• Tampere University: collaborator
• Turku University Hospital: collaborator
• Oulu University Hospital: collaborator
• Kuopio University Hospital: collaborator

Study Sites (1)

University of Oulu

Oulu, 90014, Finland

Location

Related Publications (7)

• Hietaharju M, Napankangas R, Sipila K, Teerijoki-Oksa T, Tanner J, Kemppainen P, Tolvanen M, Suvinen T. Importance of the Graded Chronic Pain Scale as a Biopsychosocial Screening Instrument in TMD Pain Patient Subtyping. J Oral Facial Pain Headache. 2021 Fall;35(4):303-316. doi: 10.11607/ofph.2983.

  PMID: 34990499 BACKGROUND

• Huhtela OS, Napankangas R, Suominen AL, Karppinen J, Kunttu K, Sipila K. Association of psychological distress and widespread pain with sympatoms of temporomandibular disorders and self-reported bruxism in students. Clin Exp Dent Res. 2021 Dec;7(6):1154-1166. doi: 10.1002/cre2.472. Epub 2021 Jul 20.

  PMID: 34289266 BACKGROUND

• Hayes-Skelton SA, Usmani A, Lee JK, Roemer L, Orsillo SM. A Fresh Look at Potential Mechanisms of Change in Applied Relaxation for Generalized Anxiety Disorder: A Case Series. Cogn Behav Pract. 2012 Aug;19(3):451-462. doi: 10.1016/j.cbpra.2011.12.005.

  PMID: 23888107 BACKGROUND

• Kemani MK, Hesser H, Olsson GL, Lekander M, Wicksell RK. Processes of change in Acceptance and Commitment Therapy and Applied Relaxation for long-standing pain. Eur J Pain. 2016 Apr;20(4):521-31. doi: 10.1002/ejp.754. Epub 2015 Dec 18.

  PMID: 26684472 BACKGROUND

• Espie CA, Kyle SD, Hames P, Gardani M, Fleming L, Cape J. The Sleep Condition Indicator: a clinical screening tool to evaluate insomnia disorder. BMJ Open. 2014 Mar 18;4(3):e004183. doi: 10.1136/bmjopen-2013-004183.

  PMID: 24643168 BACKGROUND

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

• Huhtela OS, Koivisto N, Hagg V, Sipila K. Effectiveness of applied relaxation method vs splint in treatment of temporomandibular disorders in Finnish students. J Oral Rehabil. 2020 Feb;47(2):123-131. doi: 10.1111/joor.12884. Epub 2019 Nov 9.

  PMID: 31493297 BACKGROUND

Related Links

• Researcher profile of Kirsi Sipilä/ University of Oulu, Finland

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 19, 2025
• Study Start: January 8, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FI (1)