Additional Effects of Therapeutic Exercises Under a Behavioral Umbrella for Chronic Temporomandibular Disorders Treatment
- Conditions
- Temporomandibular Joint Dysfunction Syndrome
- Interventions
- Procedure: Manual TreatmentProcedure: Myofunctional Motor control exercises
- Registration Number
- NCT03596606
- Lead Sponsor
- Maxilofacial Institute Bara Gaseni
- 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.
- Detailed Description
TMD is an alteration of the jaw function associated with disorders at the mastication muscles, mandibular joint and its associated tissues. It constitutes a major health problem since it's one of the main causes of oro-facial chronic pain and interferes with daily life. It is associated with headache, otological symptoms, cervical dysfunction and alterations in posture at the cervical level. The TMD involves genetic, anatomical, hormonal factors, traumatisms, motor behaviour, psycho-social aspects and occlusal problems.
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. It can even cause the pain to become chronic. The most prevalent symptoms in TMD are somatization and depression. Chronic pain can lead to plastic changes in the brain that lead to hyper-excitability of the central nervous system. Persistent pain produces protective memories that involve antalgic behaviour, avoidance and kinesiophobia. The literature shows that somatization, depression, fear of pain, fear of movement and catastrophism in conjunction with the amplification of pain are key factors in the chronification of TMD.
The TMD treatment must provide the ideal circumstances for the repair and adaptation. The TMD is usually a benign self-limiting process, so the guidelines always recommend non-invasive, reversible treatments in the first instance and within the bio-psycho-social approach.
For conservative management, the most evidence-based approach is manual therapy (MT). The one that has demonstrated more effectiveness is the mobilisation with impulse and / or mobilisation both at cervical and mandibular level. MT improves motor response, range of motion and modulates pain intensity via peripheral, medullary and supraspinal mechanisms. Theories suggest that hypoalgesia is caused by several mechanisms mediated by the periaqueductal gray substance.
Different studies analyse MT and motor control exercises (MC) as a whole or separately, comparing them with other therapies such as education, splints, medication, botulinum toxin, arthroplasty and arthroscopy. In these cases, MT with MC are superior to these therapies. Despite this, MC exercises do not suggest adding significant improvement in the treatment of TMD, at least in the short term. Shafer et al., In a recent systematic review, state that there is currently no evidence for the use of MC exercises of any kind for the management of TMD in general. However, according to a recent research line MC with education is the clue for the management of chronic pain. The objective of the exercises is to perform a cognitive approach to provide the desensitization of the central nervous system, generate new memories and eliminate the protective movement associated with chronic pain. It also promotes eliminating catastrophism, avoidance and fear of pain behaviour associated with chronification. This leads us to think that it should be studied more carefully if CM performed with a cognitive approach adds beneficial effect to MT in the treatment of chronic TMD not only in purely mechanical aspects but also in psycho social aspects of the individual and longer term.
The current studies are of low quality, have biases in the selection, randomisation and allocation concealment. Patient selection and diagnostic criteria are not standardised. There is a lack of blind of the evaluator and examiner. The therapy or exercise is not well described making them difficult to reproduce. The new lines of research require more detail about the type of exercise to be performed and the MT applied as recommended by the intervention report guides.
HYPOTHESIS The combination of MT and Myofunctional MC (MMC) is more effective than MT applied in a unique way for the treatment of pain, function and psycho social symptoms associated with chronic TMD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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.
- 6 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual Treatment Manual Treatment The control group will receive only Manual treatment (TO). The patient will receive five sessions, one session every week. Myofunctional Motor Control Exercises Manual Treatment 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. Myofunctional Motor Control Exercises Myofunctional Motor control exercises 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.
- Primary Outcome Measures
Name Time Method Change from Baseline Cranio Facial Pain and Disability Index during 3 months (CF-PDI) 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). 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.
- Secondary Outcome Measures
Name Time Method 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). It will be measured with a vernier caliper with an accuracy of 0.5 millimeters. The distance between the upper and lower central incisors will be measured. The measure will be taken with the patient sitting on the assessor's chair. It is considered a clinically relevant improvement an opening difference of 6mm.
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). The Spanish version TSK-11 is a self-assessment tool that evaluates the fear of reinjury due to movement. The score goes from 11 to 44 points. Higher results indicate high values of fear of movement, pain and injury itself. The minimum relevant change is 5,659.
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). The position of the head measured with the "Cervical Range of Motion "(CROM). The minimum relevant change is considered 1.27 cm.
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). It will be measured with the Occlusal T-Scan ® analysis system (Teskcan Inc., South Boston, MA, USA) that records different parameters of the dynamics of bite. Uses a thin and reusable intraoral sensor in the form of an arch dental. Obtains quantitative values of the bite.
The value of the force of the bite is expressed:
• In relation to the forces of the left side and the forces of the right side. The perfect balance would be 1. It will be the lateral ratio distribution.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). It consists of 3 subscales (impotence, rumination and magnification). The minimum relevant change is identified in 9.1 points.
Trial Locations
- Locations (1)
Calle Londres, 28, 4
🇪🇸Barcelona, Spain