Temporomandibular Joint Dysfunction SyndromeNCT01825629
Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome
A study testing Multidisciplinary 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 the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies 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?
- Multidisciplinary therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Apr 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: Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial
The purpose of this study is to determine the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies 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 physical therapy, manual therapy and deontology therapy to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and temporomandibular dysfunction in patients with fibromyalgia syndrome.
Methods and measures: seventy patients will be randomly assigned to experimental or placebo control group. The experimental group will receive 30 sessions (twice a weeks) of physical therapy, manual therapy and deontology therapy. Pain intensity, impact of fibromyalgia symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and temporomandibular dysfunction will be collected in both groups al baseline, 15 weeks and 20 weeks after 48-hr the last intervention in the experimental and placebo control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with independent Student t-test for continuous data and chi-square tests of independence for categorical data. Separate 2x3 model ANOVA with time (baseline, 15 weeks and 20 weeks) as the within-subjects factor, group (experimental, placebo control) will be determine the effects of the multidisciplinary treatment.
- Being tested
- Multidisciplinary therapy, Placebo
- Keywords
- Pain, Temporomandibular joint, Manual therapy, Physical therapy, Fibromyalgia Syndrome
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary therapyOther
Physical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), 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 temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid.
Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Multidisplinary Therapy | Experimental | The multidisciplinary therapy involves the application of physical therapy, manual therapy and deontology therapy. This multidisciplinary therapy will be administered twice a week for 15 weeks. Receives: Other: Multidisciplinary therapy |
| One technique of myofascial release | Placebo comparator | A physiotherapist administered 15 sessions of "induction occipital" once a week. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on pain intensity
The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.
Measured: At baseline, 15 weeks and 20 weeks
Secondary outcomes (7)
Change in 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, 15 weeks and 20 weeks
Change in 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, 15 weeks and 20 weeks
Change on 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 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, 15 weeks and 20 weeks
Change in physical function
The fibromyalgia impact questionnaire 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. This questionnaire 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, 15 weeks and 20 weeks
Change on quality of sleep
Pittsburgh Sleep Quality Index Questionnaire 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, 15 weeks and 20 weeks
Change on 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, 15 weeks and 20 weeks
Change on state-trait anxiety
The State-Trait Anxiety Inventory 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. This inventory allows obtaining the scores of both scales separately.
Measured: At baseline, 15 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionOct 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
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
- Investigators
- Adelaida M Castro-Sánchez, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825629
- Sponsor's protocol ID
- UAL-321-15/03/2013
- Status last verified
- Dec 2013
- First submitted
- 25 Mar 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.
PubMed 20213036Fricton JR, Ouyang W, Nixdorf DR, Schiffman EL, Velly AM, Look JO. Critical appraisal of methods used in randomized controlled trials of treatments for temporomandibular disorders. J Orofac Pain. 2010 Spring;24(2):139-51.
PubMed 20401352Oliveira-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 20436241Santos Tde S, Piva MR, Ribeiro MH, Antunes AA, Melo AR, Silva ED. Lasertherapy efficacy in temporomandibular disorders: control study. Braz J Otorhinolaryngol. 2010 May-Jun;76(3):294-9. doi: 10.1590/S1808-86942010000300004.
PubMed 20658006La Touche R, Paris-Alemany A, von Piekartz H, Mannheimer JS, Fernandez-Carnero J, Rocabado M. The influence of cranio-cervical posture on maximal mouth opening and pressure pain threshold in patients with myofascial temporomandibular pain disorders. Clin J Pain. 2011 Jan;27(1):48-55. doi: 10.1097/AJP.0b013e3181edc157.
PubMed 20733480Silant'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 20737707Ariji 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 20868996Miernik 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 22318373
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
- Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01825629
- Acronym / sponsor ID
- UAL-321-15/03/2013
- Keywords
- Pain, Temporomandibular joint, Manual therapy, Physical therapy, Fibromyalgia Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Apr 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 the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies 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 physical therapy, manual therapy and deontology therapy to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and temporomandibular dysfunction in patients with fibromyalgia syndrome.
Methods and measures: seventy patients will be randomly assigned to experimental or placebo control group. The experimental group will receive 30 sessions (twice a weeks) of physical therapy, manual therapy and deontology therapy. Pain intensity, impact of fibromyalgia symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and temporomandibular dysfunction will be collected in both groups al baseline, 15 weeks and 20 weeks after 48-hr the last intervention in the experimental and placebo control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with independent Student t-test for continuous data and chi-square tests of independence for categorical data. Separate 2x3 model ANOVA with time (baseline, 15 weeks and 20 weeks) as the within-subjects factor, group (experimental, placebo control) will be determine the effects of the multidisciplinary treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisplinary Therapy | Experimental | Other: Multidisciplinary therapyThe multidisciplinary therapy involves the application of physical therapy, manual therapy and deontology therapy. This multidisciplinary therapy will be administered twice a week for 15 weeks. |
| One technique of myofascial release | Placebo comparator | Other: PlaceboA physiotherapist administered 15 sessions of "induction occipital" once a week. |
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 |
|---|---|---|
| Multidisciplinary therapyPhysical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), 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 temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid. Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks. | Other | Multidisplinary Therapy |
| Placebo | Other | One technique of myofascial release |
Primary outcome
Change on pain intensity
Time frame: At baseline, 15 weeks and 20 weeks
The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.
7 secondary outcomes
Change in temporomandibular dysfunction
Time frame: At baseline, 15 weeks and 20 weeks
Change in quality of life SF-36
Time frame: At baseline, 15 weeks and 20 weeks
Change on index of widespread pain and symptom severity
Time frame: At baseline, 15 weeks and 20 weeks
Change in physical function
Time frame: At baseline, 15 weeks and 20 weeks
Change on quality of sleep
Time frame: At baseline, 15 weeks and 20 weeks
Change on rates of depression
Time frame: At baseline, 15 weeks and 20 weeks
Change on state-trait anxiety
Time frame: At baseline, 15 weeks and 20 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 20213036Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.
- Background: PubMed 20401352Fricton JR, Ouyang W, Nixdorf DR, Schiffman EL, Velly AM, Look JO. Critical appraisal of methods used in randomized controlled trials of treatments for temporomandibular disorders. J Orofac Pain. 2010 Spring;24(2):139-51.
- 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 20658006Santos Tde S, Piva MR, Ribeiro MH, Antunes AA, Melo AR, Silva ED. Lasertherapy efficacy in temporomandibular disorders: control study. Braz J Otorhinolaryngol. 2010 May-Jun;76(3):294-9. doi: 10.1590/S1808-86942010000300004.
- Background: PubMed 20733480La Touche R, Paris-Alemany A, von Piekartz H, Mannheimer JS, Fernandez-Carnero J, Rocabado M. The influence of cranio-cervical posture on maximal mouth opening and pressure pain threshold in patients with myofascial temporomandibular pain disorders. Clin J Pain. 2011 Jan;27(1):48-55. doi: 10.1097/AJP.0b013e3181edc157.
- Background: PubMed 20737707Silant'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.
- Background: PubMed 20868996Ariji 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.
- 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.
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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 principal investigator
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 Multidisciplinary 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. Some participants in this study may receive a placebo. 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 on pain intensity (time frame: At baseline, 15 weeks and 20 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 NCT01825629, 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.