Temporomandibular Joint Dysfunction SyndromeNCT03596606
Additional Effects of Therapeutic Exercises Under a Behavioral Umbrella for Chronic Temporomandibular Disorders Treatment
A study testing Manual Treatment in people with Temporomandibular Joint Dysfunction Syndrome, run by Maxilofacial Institute Bara Gaseni at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 100 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Manual Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 16 Sep 2019to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Effects of Therapeutic Exercises Under a Behavioral Umbrella for Chronic Temporomandibular Disorders Treatment. A Double-blind Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Manual Treatment, Myofunctional Motor control exercises
- Keywords
- Chronic Facial Pain, Osteopathic Manual treatment, Therapeutic Exercise
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TreatmentProcedure or surgery
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.
Myofunctional Motor control exercisesProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Manual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
The position of the head measured with the "Cervical Range of Motion "(CROM). The minimum relevant change is considered 1.27 cm.
Measured: 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)
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.
Measured: 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)
It consists of 3 subscales (impotence, rumination and magnification). The minimum relevant change is identified in 9.1 points.
Measured: 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)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start16 Sep 2019
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxilofacial Institute Bara Gaseni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristian Justribo manion, MSc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596606
- Sponsor's protocol ID
- 2018/33-CMF-HUSC
- Status last verified
- May 2023
- First submitted
- 28 Jun 2018
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
PubMed 26294683Chaves TC, Turci AM, Pinheiro CF, Sousa LM, Grossi DB. Static body postural misalignment in individuals with temporomandibular disorders: a systematic review. Braz J Phys Ther. 2014 Nov-Dec;18(6):481-501. doi: 10.1590/bjpt-rbf.2014.0061. Epub 2014 Oct 31.
PubMed 25590441Butts R, Dunning J, Perreault T, Mettille J, Escaloni J. Pathoanatomical characteristics of temporomandibular dysfunction: Where do we stand? (Narrative review part 1). J Bodyw Mov Ther. 2017 Jul;21(3):534-540. doi: 10.1016/j.jbmt.2017.05.017. Epub 2017 May 31.
PubMed 28750961Celic R, Panduric J, Dulcic N. Psychologic status in patients with temporomandibular disorders. Int J Prosthodont. 2006 Jan-Feb;19(1):28-9.
PubMed 16479755Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.
PubMed 25090974Maisa Soares G, Rizzatti-Barbosa CM. Chronicity factors of temporomandibular disorders: a critical review of the literature. Braz Oral Res. 2015;29:S1806-83242015000100300. doi: 10.1590/1807-3107BOR-2015.vol29.0018. Epub 2015 Jan 13.
PubMed 25590505Butts R, Dunning J, Pavkovich R, Mettille J, Mourad F. Conservative management of temporomandibular dysfunction: A literature review with implications for clinical practice guidelines (Narrative review part 2). J Bodyw Mov Ther. 2017 Jul;21(3):541-548. doi: 10.1016/j.jbmt.2017.05.021. Epub 2017 Jun 1.
PubMed 28750962Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.
PubMed 26144684Monaco A, Cozzolino V, Cattaneo R, Cutilli T, Spadaro A. Osteopathic manipulative treatment (OMT) effects on mandibular kinetics: kinesiographic study. Eur J Paediatr Dent. 2008 Mar;9(1):37-42.
PubMed 18380529Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.
PubMed 20436241Cuccia AM, Caradonna C, Annunziata V, Caradonna D. Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: a randomized controlled trial. J Bodyw Mov Ther. 2010 Apr;14(2):179-84. doi: 10.1016/j.jbmt.2009.08.002. Epub 2009 Sep 20.
PubMed 20226365Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.
PubMed 23768273Kalamir A, Pollard H, Vitiello A, Bonello R. Intra-oral myofascial therapy for chronic myogenous temporomandibular disorders: a randomized, controlled pilot study. J Man Manip Ther. 2010 Sep;18(3):139-46. doi: 10.1179/106698110X12640740712374.
PubMed 21886424Kalamir A, Graham PL, Vitiello AL, Bonello R, Pollard H. Intra-oral myofascial therapy versus education and self-care in the treatment of chronic, myogenous temporomandibular disorder: a randomised, clinical trial. Chiropr Man Therap. 2013 Jun 5;21:17. doi: 10.1186/2045-709X-21-17. eCollection 2013.
PubMed 23738586Guarda-Nardini L, Stecco A, Stecco C, Masiero S, Manfredini D. Myofascial pain of the jaw muscles: comparison of short-term effectiveness of botulinum toxin injections and fascial manipulation technique. Cranio. 2012 Apr;30(2):95-102. doi: 10.1179/crn.2012.014.
PubMed 22606852
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Therapeutic Exercises Under a Behavioral Umbrella for Chronic Temporomandibular Disorders Treatment. A Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03596606
- Acronym / sponsor ID
- 2018/33-CMF-HUSC
- Keywords
- Chronic Facial Pain, Osteopathic Manual treatment, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Maxilofacial Institute Bara GaseniUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Myofunctional Motor Control Exercises | Experimental | Procedure: Manual Treatment, Procedure: Myofunctional Motor control exercisesBoth 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. |
| Manual Treatment | Active comparator | Procedure: Manual TreatmentThe control group will receive only Manual treatment (TO). The patient will receive five sessions, one session every week. |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TreatmentThe 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. | Procedure or surgery | Manual Treatment, Myofunctional Motor Control Exercises |
| Myofunctional Motor control exercisesThe 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 | Procedure or surgery | Myofunctional Motor Control Exercises |
Primary outcome
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.
5 secondary outcomes
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Background: PubMed 26294683Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
- Background: PubMed 25590441Chaves TC, Turci AM, Pinheiro CF, Sousa LM, Grossi DB. Static body postural misalignment in individuals with temporomandibular disorders: a systematic review. Braz J Phys Ther. 2014 Nov-Dec;18(6):481-501. doi: 10.1590/bjpt-rbf.2014.0061. Epub 2014 Oct 31.
- Background: PubMed 28750961Butts R, Dunning J, Perreault T, Mettille J, Escaloni J. Pathoanatomical characteristics of temporomandibular dysfunction: Where do we stand? (Narrative review part 1). J Bodyw Mov Ther. 2017 Jul;21(3):534-540. doi: 10.1016/j.jbmt.2017.05.017. Epub 2017 May 31.
- Background: PubMed 16479755Celic R, Panduric J, Dulcic N. Psychologic status in patients with temporomandibular disorders. Int J Prosthodont. 2006 Jan-Feb;19(1):28-9.
- Background: PubMed 25090974Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.
- Background: PubMed 25590505Maisa Soares G, Rizzatti-Barbosa CM. Chronicity factors of temporomandibular disorders: a critical review of the literature. Braz Oral Res. 2015;29:S1806-83242015000100300. doi: 10.1590/1807-3107BOR-2015.vol29.0018. Epub 2015 Jan 13.
- Background: PubMed 28750962Butts R, Dunning J, Pavkovich R, Mettille J, Mourad F. Conservative management of temporomandibular dysfunction: A literature review with implications for clinical practice guidelines (Narrative review part 2). J Bodyw Mov Ther. 2017 Jul;21(3):541-548. doi: 10.1016/j.jbmt.2017.05.021. Epub 2017 Jun 1.
- Background: PubMed 26144684Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.
- Background: PubMed 18380529Monaco A, Cozzolino V, Cattaneo R, Cutilli T, Spadaro A. Osteopathic manipulative treatment (OMT) effects on mandibular kinetics: kinesiographic study. Eur J Paediatr Dent. 2008 Mar;9(1):37-42.
- Background: PubMed 20436241Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.
- Background: PubMed 20226365Cuccia AM, Caradonna C, Annunziata V, Caradonna D. Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: a randomized controlled trial. J Bodyw Mov Ther. 2010 Apr;14(2):179-84. doi: 10.1016/j.jbmt.2009.08.002. Epub 2009 Sep 20.
- Background: PubMed 23768273Tuncer AB, Ergun N, Tuncer AH, Karahan S. Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial. J Bodyw Mov Ther. 2013 Jul;17(3):302-8. doi: 10.1016/j.jbmt.2012.10.006. Epub 2012 Nov 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Justribo manion, MSc principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Treatment in people with Temporomandibular Joint Dysfunction Syndrome, run by Maxilofacial Institute Bara Gaseni at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596606, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.