Additional Effects of Therapeutic Exercises Under a Behavioral Umbrella for Chronic Temporomandibular Disorders Treatment

NCT03596606 | Completed DMC

• 1 other identifier: 2018/33-CMF-HUSC
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular dysfunction (TMD) It's one of the main causes of oro-facial chronic pain. The psychological aspects of patients with TMD have a huge importance, affecting their ability to manage pain and interfering with the resolution of the picture. Different studies analyse Manual therapy (MT) and motor control exercises (MC) as a whole or separately. In these cases, MT with MC shows promising results. Despite this, MC do not suggest adding significant improvement at least at short term. In the other side, according to a recent research line, MC with education is the clue for chronic pain management. This leads us to think that it should be studied more carefully if MC performed with a cognitive approach adds beneficial effect to MT not only in purely mechanical aspects but also in psycho-social aspects of the individual and at longer term. HYPOTHESIS The combination of MT and MC is more effective than MT applied in a unique way for the treatment of pain, function and psycho-social symptoms associated with chronic TMD.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

Chronic Facial Pain; Osteopathic Manual treatment; Therapeutic Exercise

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Cranio Facial Pain and Disability Index during 3 months (CF-PDI)

  It contains 21 Items divided into two sub-scales. The first sub-scale measures pain and associated disability. The second sub-scale measures the functional status of the jaw. The questionnaire scores from 0 to 63 points and the relevant minimum change is 7 points.

  5 measures: Before the first intervention (CF-PDI1_ baseline data), 2 weeks later after the second session (CF-PDI2), 5 weeks later after the last session (CF-PDI3), 7 weeks later (CF-PDI4) and up to 3 months (CF-PDI5).

Secondary Outcomes (5)

• Change from Baseline Mandibular Opening without pain during 3 months (MO)

  5 measures: Before the first intervention (MO1_ baseline data), 2 weeks later after the second session (MO2), 5 weeks later after the last session (MO3), 7 weeks later (MO4) and up to 3 months (MO5).

• Change from Baseline Position of the head during 3 months (CROM)

  5 measures: Before the first intervention (CROM1_ baseline data), 2 weeks later after the second session (CROM2), 5 weeks later after the last session (CROM3), 7 weeks later (CROM4) and up to 3 months (CROM5).

• Change from Baseline Occlusal force distribution during 3 months (FD)

  5 measures: Before the first intervention (FD1_ baseline data), 2 weeks later after the second session (FD2), 5 weeks later after the last session (FD3), 7 weeks later (FD4) and up to 3 months (FD5).

• Change from Baseline Pain Catastrophism scale during 3 months (PCS)

  5 measures: Before the first intervention (PCS1_ baseline data), 2 weeks later after the second session (PCS2), 5 weeks later after the last session (PCS3), 7 weeks later (PCS4) and up to 3 months (PCS5).

• Change from Baseline Kinesiophobia during 3 months (TSK-11)

  5 measures: Before the first intervention (TSK1_ baseline data), 2 weeks later after the second session (TSK2), 5 weeks later after the last session (TSK3), 7 weeks later (TSK4) and up to 3 months (TSK5).

Study Arms (2)

Myofunctional Motor Control Exercises

EXPERIMENTAL

Both groups will be treated with Manual treatment and in one of them the myofunctional motor control treatment will be added as intervention. The experimental group will be the one that will receive the combined treatment. The patient will receive five sessions, one session every week.

Procedure: Manual Treatment; Procedure: Myofunctional Motor control exercises

Manual Treatment

ACTIVE COMPARATOR

The control group will receive only Manual treatment (TO). The patient will receive five sessions, one session every week.

Procedure: Manual Treatment

Interventions

Manual Treatment PROCEDURE

The manual treatment will be adapted to each patient at the discretion of the therapist, being able to select all or part of the following osteopathic techniques in each session. * Soft tissue techniques. * Articulatory techniques applied at cervical level * Osteopathic manipulation techniques applied at the affected jaw/s. * Functional Indirect technique at the level of the affected jaw/s: For Type I or II diagnosis.

Manual Treatment; Myofunctional Motor Control Exercises

Myofunctional Motor control exercises PROCEDURE

The protocol is a set of 8 exercises to improve the execution of the function in the stomatognathic and cervical area. The therapist explains the objectives of the exercises and the patient performs it after each session and at home three times a day. The first day before performing the myofunctional exercises, will be an explanatory talk prior to the exercises in order to educate the patient. The second day, before doing the exercises, will review the concept of memory of pain and the benefits of doing the exercises

Myofunctional Motor Control Exercises

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of TMD type: I myofascial and or II displacement of disc and or III other arthralgias. According to the diagnostic criteria of Dworkin S. Et al. The clinical examination and algorithms that will be carried are the ones included in the the axis I of the Diagnostic criteria for TMD (DC/TMD). We will use the Spanish version.
• months of TMD evolution and pain in the last 30 days.
• Signs of pain and disability of at least 7 points on the CF-PDI.
• Normal neurological examination.
• Normal orthopantomography (without fracture or severe joint bone disease).
• To accept the participation and sign the informed consent.

You may not qualify if:

• Severe dermatological or intrabuccal problems, head or neck injuries.
• Orthopantomography with recent fractures or severe articular bone pathology.
• Previous treatment (three months before) with manual therapy splints or acupuncture.
• Previous diagnosis of severe psychiatric disorder.
• Systemic, rheumatologic or neurodegenerative diseases.
• Previous diagnosis of primary headache or unilateral neck pain of recent appearance.
• Associated clinic of neurological pain, radiculopathy or myelopathy.
• Not understanding Castilian or Catalan.

Sponsors & Collaborators

• Maxilofacial Institute Bara Gaseni: lead

Study Sites (1)

Calle Londres, 28, 4

Barcelona, 08029, Spain

Location

Related Publications (24)

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MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Study Officials

• Cristian Justribo manion, MSc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal evaluator will be blinded in relation to the study groups. The person responsible for taking the variables (baseline data, reassessments and data analysis) will be a therapist and a medical doctor unrelated to the recruitment and treatment. Due to the nature of the interventions, it is not possible to mask the therapist responsible for the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both groups will be treated with Osteopathic Treatment and in one of them it will be added the intervention with cognition targeted myofunctional motor control exercises.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 24, 2018
• Study Start: September 16, 2019
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

ES (1)