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Efficacy of Osteopathic Manual Therapy Combined With Myofunctional Exercise for Temporomandibular Chronic Disorders

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ClinicalTrials.gov Identifier: NCT03596606
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Maxilofacial Institute Bara Gaseni

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date January 29, 2019
Estimated Study Start Date  ICMJE February 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
Change from Baseline Cranio Facial Pain and Disability Index during 3 months (CF-PDI) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03596606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Change from Baseline Mandibular Opening without pain during 3 months (MO) [ Time Frame: 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 Position of the head during 3 months (CROM) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
  • Change from Baseline Kinesiophobia during 3 months (TSK-11) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Osteopathic Manual Therapy Combined With Myofunctional Exercise for Temporomandibular Chronic Disorders
Official Title  ICMJE Efficacy of Osteopathic Manual Therapy Combined With Myofunctional Exercise for the Treatment of Temporomandibular Chronic Disorders: A Single-blind Clinical Trial
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) including Osteopathic Manual therapy (OT) 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 OT and MC is more effective than OT 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) including Manual Osteopathic treatment (OT). The one that has demonstrated more effectiveness is the mobilisation with impulse and / or mobilisation both at cervical and mandibular level. OT 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.

Finally, authors such as Gary Fryer, within the osteopathic current, argue that there is a need to implement therapeutic models within the bio-psycho-social approach, with biological and psycho social factors being the key to the development and management of somatic pain. This encourages the authors to carry out this study and include new paradigms in osteopathy.

HYPOTHESIS The combination of OT and Myofunctional MC (MMC) is more effective than OT applied in a unique way for the treatment of pain, function and psycho social symptoms associated with chronic TMD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Single (Investigator)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Temporomandibular Joint Dysfunction Syndrome
Intervention  ICMJE
  • Procedure: Osteopathic Treatment

    The Osteopathic 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.
  • Procedure: Myofunctional Motor control exercises

    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

Study Arms  ICMJE
  • Experimental: Myofunctional Motor Control Exercises

    Both groups will be treated with Osteopathic 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.

    Interventions:
    • Procedure: Osteopathic Treatment
    • Procedure: Myofunctional Motor control exercises
  • Active Comparator: Osteopathic Treatment
    The control group will receive only osteopathic treatment (TO). The patient will receive five sessions, one session every week.
    Intervention: Procedure: Osteopathic Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cristian Justribo manion, MSc 672057031 cristian@cmtosteopatia.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03596606
Other Study ID Numbers  ICMJE 2018/33-CMF-HUSC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Maxilofacial Institute Bara Gaseni
Study Sponsor  ICMJE Maxilofacial Institute Bara Gaseni
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cristian Justribo manion, MSc
PRS Account Maxilofacial Institute Bara Gaseni
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP