Temporomandibular Joint Dysfunction SyndromeNCT01800279
Physiotherapy and Deontology in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.
A study testing Physiotherapy Protocol and Deontology Therapy in people with Temporomandibular Joint Dysfunction Syndrome, run by Universidad de Almeria at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Physiotherapy Protocol and Deontology Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Dec 2013
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia syndrome.
- Agreement to attend evening therapy sessions.
- A chief complaint of acute pain (duration <6 months) in the temporomandibular joint on at least one side.
- The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
Who cannot join
- History of recent trauma.
- Therapeutic co-interventions during treatment.
- Indication for surgical treatment of temporomandibular joint.
- Edentulism.
- Physical or mental illness that precludes attendance at therapy sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Effectiveness of Physical Therapy and Deontology for Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.
The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.
Read the detailed description
Design: randomized clinical trial. Objective: to compare the therapeutic effects of physiotherapy and deontology protocol to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and diagnostic criteria for research temporomandibular joint dysfunction in patients with fibromyalgia syndrome (FMS).
Background: the results on physiotherapy benefits for temporomandibular joint dysfunction in patients with FMS are controversial. Descriptive data and intervention studies are still scarce.
Methods and measures: sixty patients will be randomly assigned to experimental or control group. The experimental group will receive 24 sessions (twice a week) of kinesitherapy and myofascial release protocol, whereas the control group will undergo to deontology therapy (porting a deprogramming occlusal splint every night, an average of 8 hours per day, for 12 weeks of the treatment). Pain levels, impact of FMS symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction will be collected in both groups at baseline and 12 weeks after 48-hr the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups independent Student t-test for continuous data and χ2 tests of independence for categorical data. Separate 2x2 mixed model ANCOVAs with time (pre-post) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment on pain, function, quality of sleep,depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction as the dependent variables.
- Being tested
- Physiotherapy Protocol, Deontology Therapy
- Keywords
- Fibromyalgia Syndrome, Temporomandibular Joint, Pain.
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy ProtocolOther
Kinesitherapy
- Patient: supine position on the stretcher with a loop of 6 cm in the cervical area.
- Tongue in the palate for all applied exercises.
- Repetitions of each exercise: 8. Cervical traction. Cranium fore flexion 15 °. Open-close mouth dental contactless (10mm). Opening movement with a small resistor (one finger on chin).
Flexion of the head, without actually lifting, resisting in the front. Occipital extension. Cranium fore flexion 15 °. Cervical traction.
Myofascial Therapy. Induction suboccipital. Compression - decompression of the TMJ (Temporomandibular Joint). Horizontal Induction TMJ. Deep fascia induction in the temporal region. Deep Induction of the masseter fascia. Deep Induction of the external pterygoid. Induction of intraoral pterygoid.
Deontology TherapyOther
For the realization of the splint, the following protocol will be developed at the Faculty of Dentistry of Granada (Spain):
- Impression of the maxilla with chromatic alginate "Phase plus" (Zhermack ©, Rovigo, Italy).
- Emptying working models in plaster-stone type IV "Elite Rock" (Zhermack ©, Rovigo, Italy).
- Deprogramming occlusal splints were made of polyester plates with terephthalic acid of 3 mm thick Clear 120 model (Dentaflux ©, Ripoll, Madrid). We used a molding machine of thermoplastic vacuum plate "The Machine" Dentaflux ©, Ripoll, Madrid.
| Study group | Role | What they receive |
|---|---|---|
| Deontology Therapy | Active comparator | The patients in the control group will port a deprogramming occlusal splint to sleep every night, an average of 8 hours per day, for 12 weeks of the treatment. Receives: Other: Deontology Therapy |
| Physiotherapy Protocol | Experimental | The physiotherapy protocol involves the application of kinesitherapy techniques and a myofascial therapy protocol. This protocol will be administered twice a week for 12 weeks. Receives: Other: Physiotherapy Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The visual analog scale (VAS), designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 for pain-free and 100 for maximum pain.
Measured: At baseline and 12 weeks
Secondary outcomes (7)
Temporomandibular Dysfunction.
Dworkin and LeResche present a multiaxial evaluation system that integrates the relevant aspects for the temporomandibular dysfunction in two axes. The exploration model consists of a protocol detailing the tests to be applied, and other specifications of the procedure to be followed by the professional:
- Temporomandibular pain.
- Pattern jaw opening.
- Vertical movement range.
- Sounds of the temporomandibular joint in palpation during vertical movement.
- Mandibular excursive movements.
- Pain extraoral muscle tenderness.
- Joint pain on palpation.
- Muscle pain during intraoral palpation.
Measured: At baseline and 12 weeks
Quality of Life (SF-36)
The assessment of Quality of Life (SF-36) covers 8 dimensions of health status. It contains 36 items covering two areas, the functional status and the emotional wellness. The area of the functional state is represented by the following dimensions: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items). The wellness area includes the dimensions of mental health (5 items), vitality (4 items), pain (2 items). Finally, the general health assessment includes the dimension of perception of general health (5 items) and the health change over the time (one item, which is not part of the final score).
Measured: At baseline and 12 weeks
Index of Widespread Pain and Symptom Severity
This simple clinical case definition of fibromyalgia properly classifies the 88.1% of the cases classified by the ACR (American College of Rheumatology) classification criteria, and it does not require a physical or tender point. The symptom severity score allows the assessment of the severity of the symptoms of fibromyalgia in people with current or previous fibromyalgia, and those in which the criteria have not been applied yet. This questionnaire is especially useful in the longitudinal assessment of patients with marked symptom variability.
Measured: At baseline and 12 weeks
Physical Function.
The fibromyalgia impact questionnaire (FIQ) consists of 10 items. The first item is composed of 11 subitems in which is valued the physical function. In the second and third items, patients indicate the number of days in which they disrupt their daily activity due to pain, or otherwise the days they find improvement. The impact caused by the symptoms of fibromyalgia in the physical and mental health of the patients was measured by the Spanish version of the Impact of Fibromyalgia Questionnaire. The FIQ assesses the following dimensions: feeling good, physical function, missing work and work capacity, physical, psychological and social components and global wellness. Also, it includes six visual analog scales for assessing fatigue, pain, stiffness, morning tiredness, anxiety and depression.
Measured: At baseline and 12 weeks
Quality of Sleep.
Pittsburgh Sleep Quality Index Questionnaire (PSQI) consists of 24 items, and which interrogate issues such as the quality of sleep that the subject he has, or the frequency of certain events - such as difficulty falling asleep during the first half an hour or the presence of nightmares- are answered by an ordinal scale with four grades. In the correction of this questionnaire, seven scores are obtained which inform us of the components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, the use of hypnotic medication, and daytime dysfunction. Each of these components receives a discrete score which can range from 0 to 3. A score of 0 indicates that there are no problems in this respect, and a score of 3 indicates serious problems at that level. The sum of the scores in each partial component generates a total score, which can range from 0 to 21.
Measured: At baseline and 12 weeks
Rates of Depression
The Beck inventory for depression is a self-administered questionnaire of 21 items that assesses a wide range of depressive symptoms. Its content emphasizes more the cognitive component of depression, and the symptoms of this area represent about 50% of the total score of the questionnaire, with symptoms of somatic / vegetative. In the second block, of the 21 items, 15 refer to eco-cognitive symptoms, and the remaining 6 to somatic-vegetative symptoms. Each item has four response alternatives listed from low to high severity, assessing the severity / intensity of the symptom. The range of the score is 0-63 points. The aim of this questionnaire is to quantify the symptoms, not provide a diagnosis. The breakpoints usually accepted to graduate the intensity/severity are the followings:
- No Depression: 0-9 points.
- Mild depression: 10-18 points
- Moderate Depression: 19-29 points
- Severe depression: ≥ 30 points
Measured: At baseline and 12 weeks
State-Trait Anxiety.
The State-Trait Anxiety Inventory (STAI) measures a stable personality dimension (trait anxiety or tendency to anxiety), also includes a subscale of state, to detect anxiety behaviors. In the questionnaire, consisting of 40 items (20 for each level), the subjects have to describe how they feel generally, in the case of the trait anxiety scale, and how they feel when they answer, in the case of anxiety scale as a state. The STAI allows obtaining the scores of both scales separately.
Measured: At baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada, Andaluz Health Service
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
- Investigators
- Adelaida M Castro-Sánchez, PhD, Study director, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800279
- Sponsor's protocol ID
- UAL-12
- Status last verified
- Dec 2013
- First submitted
- 19 Feb 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Miernik M, Wieckiewicz M, Paradowska A, Wieckiewicz W. Massage therapy in myofascial TMD pain management. Adv Clin Exp Med. 2012 Sep-Oct;21(5):681-5.
PubMed 23356206de Felicio CM, Medeiros AP, de Oliveira Melchior M. Validity of the 'protocol of oro-facial myofunctional evaluation with scores' for young and adult subjects. J Oral Rehabil. 2012 Oct;39(10):744-53. doi: 10.1111/j.1365-2842.2012.02336.x. Epub 2012 Aug 1.
PubMed 22852833Guarda-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 22606852Richardson K, Gonzalez Y, Crow H, Sussman J. The effect of oral motor exercises on patients with myofascial pain of masticatory system. Case series report. N Y State Dent J. 2012 Jan;78(1):32-7.
PubMed 22474795Manfredini D, Castroflorio T, Perinetti G, Guarda-Nardini L. Dental occlusion, body posture and temporomandibular disorders: where we are now and where we are heading for. J Oral Rehabil. 2012 Jun;39(6):463-71. doi: 10.1111/j.1365-2842.2012.02291.x. Epub 2012 Mar 21.
PubMed 22435603Aggarwal A, Keluskar V. Physiotherapy as an adjuvant therapy for treatment of TMJ disorders. Gen Dent. 2012 Mar-Apr;60(2):e119-22.
PubMed 22414516Walczynska-Dragon K, Baron S. The biomechanical and functional relationship between temporomandibular dysfunction and cervical spine pain. Acta Bioeng Biomech. 2011;13(4):93-8.
PubMed 22339095Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
PubMed 22318373Dym H, Israel H. Diagnosis and treatment of temporomandibular disorders. Dent Clin North Am. 2012 Jan;56(1):149-61, ix. doi: 10.1016/j.cden.2011.08.002.
PubMed 22117948Doepel M, Nilner M, Ekberg E, LE Bell Y. Long-term effectiveness of a prefabricated oral appliance for myofascial pain. J Oral Rehabil. 2012 Apr;39(4):252-60. doi: 10.1111/j.1365-2842.2011.02261.x. Epub 2011 Oct 11.
PubMed 21985440Hunter EK. Integration of rehabilitation and acupuncture in the treatment of a professional musician with temporomandibular joint dysfunction. Acupunct Med. 2011 Dec;29(4):298-301. doi: 10.1136/aim.2010.003889. Epub 2011 Jun 16.
PubMed 21685109Armijo-Olivo S, Silvestre R, Fuentes J, da Costa BR, Gadotti IC, Warren S, Major PW, Thie NM, Magee DJ. Electromyographic activity of the cervical flexor muscles in patients with temporomandibular disorders while performing the craniocervical flexion test: a cross-sectional study. Phys Ther. 2011 Aug;91(8):1184-97. doi: 10.2522/ptj.20100233. Epub 2011 Jun 9.
PubMed 21659465Cuccia AM, Caradonna C, Caradonna D. Manual therapy of the mandibular accessory ligaments for the management of temporomandibular joint disorders. J Am Osteopath Assoc. 2011 Feb;111(2):102-12.
PubMed 21357496Ariji Y, Katsumata A, Hiraiwa Y, Izumi M, Sakuma S, Shimizu M, Kurita K, Ariji E. Masseter muscle sonographic features as indices for evaluating efficacy of massage treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Oct;110(4):517-26. doi: 10.1016/j.tripleo.2010.05.003.
PubMed 20868996Silant'eva EN. [The role of therapeutic exercises in the combined treatment and rehabilitation of patients with pain syndrome associated with the dysfunction of temporomandibular joint]. Vopr Kurortol Fizioter Lech Fiz Kult. 2010 May-Jun;(3):22-6. Russian.
PubMed 20737707
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effectiveness of Physical Therapy and Deontology for Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.
- ClinicalTrials.gov ID
- NCT01800279
- Acronym / sponsor ID
- UAL-12
- Keywords
- Fibromyalgia Syndrome, Temporomandibular Joint, Pain.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Universidad de Granada, Andaluz Health Service
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 2013 (estimated)
- 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.
The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.
Detailed description
Design: randomized clinical trial. Objective: to compare the therapeutic effects of physiotherapy and deontology protocol to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and diagnostic criteria for research temporomandibular joint dysfunction in patients with fibromyalgia syndrome (FMS).
Background: the results on physiotherapy benefits for temporomandibular joint dysfunction in patients with FMS are controversial. Descriptive data and intervention studies are still scarce.
Methods and measures: sixty patients will be randomly assigned to experimental or control group. The experimental group will receive 24 sessions (twice a week) of kinesitherapy and myofascial release protocol, whereas the control group will undergo to deontology therapy (porting a deprogramming occlusal splint every night, an average of 8 hours per day, for 12 weeks of the treatment). Pain levels, impact of FMS symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction will be collected in both groups at baseline and 12 weeks after 48-hr the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups independent Student t-test for continuous data and χ2 tests of independence for categorical data. Separate 2x2 mixed model ANCOVAs with time (pre-post) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment on pain, function, quality of sleep,depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction as the dependent variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deontology Therapy | Active comparator | Other: Deontology TherapyThe patients in the control group will port a deprogramming occlusal splint to sleep every night, an average of 8 hours per day, for 12 weeks of the treatment. |
| Physiotherapy Protocol | Experimental | Other: Physiotherapy ProtocolThe physiotherapy protocol involves the application of kinesitherapy techniques and a myofascial therapy protocol. This protocol will be administered twice a week for 12 weeks. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of fibromyalgia syndrome.
- Agreement to attend evening therapy sessions.
- A chief complaint of acute pain (duration <6 months) in the temporomandibular joint on at least one side.
- The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
Key exclusion criteria (5 listed)
- History of recent trauma.
- Therapeutic co-interventions during treatment.
- Indication for surgical treatment of temporomandibular joint.
- Edentulism.
- Physical or mental illness that precludes attendance at therapy sessions.
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 |
|---|---|---|
| Physiotherapy ProtocolKinesitherapy * Patient: supine position on the stretcher with a loop of 6 cm in the cervical area. * Tongue in the palate for all applied exercises. * Repetitions of each exercise: 8. Cervical traction. Cranium fore flexion 15 °. Open-close mouth dental contactless (10mm). Opening movement with a small resistor (one finger on chin). Flexion of the head, without actually lifting, resisting in the front. Occipital extension. Cranium fore flexion 15 °. Cervical traction. Myofascial Therapy. Induction suboccipital. Compression - decompression of the TMJ (Temporomandibular Joint). Horizontal Induction TMJ. Deep fascia induction in the temporal region. Deep Induction of the masseter fascia. Deep Induction of the external pterygoid. Induction of intraoral pterygoid. | Other | Physiotherapy Protocol |
| Deontology TherapyFor the realization of the splint, the following protocol will be developed at the Faculty of Dentistry of Granada (Spain): * Impression of the maxilla with chromatic alginate "Phase plus" (Zhermack ©, Rovigo, Italy). * Emptying working models in plaster-stone type IV "Elite Rock" (Zhermack ©, Rovigo, Italy). * Deprogramming occlusal splints were made of polyester plates with terephthalic acid of 3 mm thick Clear 120 model (Dentaflux ©, Ripoll, Madrid). We used a molding machine of thermoplastic vacuum plate "The Machine" Dentaflux ©, Ripoll, Madrid. | Other | Deontology Therapy |
Primary outcome
Pain Intensity
Time frame: At baseline and 12 weeks
The visual analog scale (VAS), designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 for pain-free and 100 for maximum pain.
7 secondary outcomes
Temporomandibular Dysfunction.
Time frame: At baseline and 12 weeks
Quality of Life (SF-36)
Time frame: At baseline and 12 weeks
Index of Widespread Pain and Symptom Severity
Time frame: At baseline and 12 weeks
Physical Function.
Time frame: At baseline and 12 weeks
Quality of Sleep.
Time frame: At baseline and 12 weeks
Rates of Depression
Time frame: At baseline and 12 weeks
State-Trait Anxiety.
Time frame: At baseline and 12 weeks
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 11 Dec 2013.
- Background: PubMed 23356206Miernik M, Wieckiewicz M, Paradowska A, Wieckiewicz W. Massage therapy in myofascial TMD pain management. Adv Clin Exp Med. 2012 Sep-Oct;21(5):681-5.
- Background: PubMed 22852833de Felicio CM, Medeiros AP, de Oliveira Melchior M. Validity of the 'protocol of oro-facial myofunctional evaluation with scores' for young and adult subjects. J Oral Rehabil. 2012 Oct;39(10):744-53. doi: 10.1111/j.1365-2842.2012.02336.x. Epub 2012 Aug 1.
- Background: PubMed 22606852Guarda-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.
- Background: PubMed 22474795Richardson K, Gonzalez Y, Crow H, Sussman J. The effect of oral motor exercises on patients with myofascial pain of masticatory system. Case series report. N Y State Dent J. 2012 Jan;78(1):32-7.
- Background: PubMed 22435603Manfredini D, Castroflorio T, Perinetti G, Guarda-Nardini L. Dental occlusion, body posture and temporomandibular disorders: where we are now and where we are heading for. J Oral Rehabil. 2012 Jun;39(6):463-71. doi: 10.1111/j.1365-2842.2012.02291.x. Epub 2012 Mar 21.
- Background: PubMed 22414516Aggarwal A, Keluskar V. Physiotherapy as an adjuvant therapy for treatment of TMJ disorders. Gen Dent. 2012 Mar-Apr;60(2):e119-22.
- Background: PubMed 22339095Walczynska-Dragon K, Baron S. The biomechanical and functional relationship between temporomandibular dysfunction and cervical spine pain. Acta Bioeng Biomech. 2011;13(4):93-8.
- Background: PubMed 22318373Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
- Background: PubMed 22117948Dym H, Israel H. Diagnosis and treatment of temporomandibular disorders. Dent Clin North Am. 2012 Jan;56(1):149-61, ix. doi: 10.1016/j.cden.2011.08.002.
- Background: PubMed 21985440Doepel M, Nilner M, Ekberg E, LE Bell Y. Long-term effectiveness of a prefabricated oral appliance for myofascial pain. J Oral Rehabil. 2012 Apr;39(4):252-60. doi: 10.1111/j.1365-2842.2011.02261.x. Epub 2011 Oct 11.
- Background: PubMed 21685109Hunter EK. Integration of rehabilitation and acupuncture in the treatment of a professional musician with temporomandibular joint dysfunction. Acupunct Med. 2011 Dec;29(4):298-301. doi: 10.1136/aim.2010.003889. Epub 2011 Jun 16.
- Background: PubMed 21659465Armijo-Olivo S, Silvestre R, Fuentes J, da Costa BR, Gadotti IC, Warren S, Major PW, Thie NM, Magee DJ. Electromyographic activity of the cervical flexor muscles in patients with temporomandibular disorders while performing the craniocervical flexion test: a cross-sectional study. Phys Ther. 2011 Aug;91(8):1184-97. doi: 10.2522/ptj.20100233. Epub 2011 Jun 9.
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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.
Adelaida M Castro-Sánchez, PhD study director
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Protocol and Deontology Therapy in people with Temporomandibular Joint Dysfunction Syndrome, run by Universidad de Almeria 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 4 inclusion and 5 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 11 Dec 2013. 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?
Pain Intensity (time frame: At baseline and 12 weeks). 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 NCT01800279, which also lists 20 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 11 Dec 2013.