Temporomandibular DisordersPhase 3NCT01544439
Occlusal Splint and Counseling to Temporomandibular Disorder
A Phase 3 study testing stabilizing appliance and Non-occluding splint, counseling in people with Temporomandibular Disorders and Stress Psychological, run by Patra-cia Rocha Coelho at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the effectiveness of the splint occlusal associated with counseling in reducing pain in patients with temporomandibular disorders, under the assumption that the occlusal appliance offers the highest rates of improvement than their placebo. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Temporomandibular Disorders, Stress Psychological, Musculoskeletal Diseases
- What is being tested?
- stabilizing appliance and Non-occluding splint, counseling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Jul 2012
- Phase
- Phase 3
- 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 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All subjects participated in this study volunteers by signing the consent form. Inclusion criteria are as follows:
- female subjects;
- aged 20 to 55 years;
- irrespective of race, social status or religion;
- presence of pain intensity of at least moderate (at least 4.0 on VAS), shown in the first clinical assessment;
- diagnosis of myofascial pain persisting for a minimum period of six months.
Who cannot join
- history of psychiatric disorders or treatment for neurological or psychological disorders;
- volunteers with severe intellectual or physical disability that would hinder the collection of data;
- history of systemic diseases that generate joint symptoms, muscle or rheumatologic, such as rheumatoid arthritis and fibromyalgia;
- pain attributed to a well-defined local cause, such as pulpitis, trigeminal neuralgia and cancer pain;
- attributable to migraine pain or infection;
- report of any previous treatment for TMD;
Show all 11Show fewer
- treatment with drugs affecting the central nervous system (muscle relaxants, anticonvulsants, opioids, and antidepressants) and treatment with analgesics and anti-inflammatory drugs, with or without prescription, concomitant therapies to be instituted in this research;
- report of facial trauma as a possible etiology of TMD;
- subject denture wearers an upper or lower;
- volunteers aged under 20 or over 55 years;
- male individuals.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36036-900
Patrícia R. Coelho, (32)9932-1100
Patricia R. Coelho
About this study
Official title: The Efficacy of Occlusal Stabilization Appliance Associated to Counseling in the Management of Myofascial Pain Chronic and in the Improvement of the Quality of Life of Patients With Temporomandibular Disorders
The aim of this study was to evaluate the effectiveness of the splint occlusal associated with counseling in reducing pain in patients with temporomandibular disorders, under the assumption that the occlusal appliance offers the highest rates of improvement than their placebo.
Read the detailed description
- The aim of this double-blind randomized control trial was to evaluate the efficacy of occlusal stabilization appliance associated to counseling in the management of myofascial pain chronic and in the improvement of the quality of life of patients with temporomandibular disorders (TMD).
- In order to reduce the likelihood of systematic errors and allow the use of statistical tests is used randomization processes or randomization of the volunteers in the different groups from a sequence generated by a specific program (Randomization.com), and the principal investigator masked for this division. For this, a second researcher, appointed to undertake the division of patients into groups that maintain confidential information from groups and their participants, revealing only the researcher therapist at the time of first therapy session. The number of individuals randomized to the experimental group will be equal to the control group.
- Study Group Intervention The reversible occlusal therapy by stabilizing appliance used by patients in Study Group shall be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. The patients will be assessed at weekly intervals (between the query and the following board installation) and then biweekly during the period of 90 days. There shall be a gradual reduction in the daily use of the plate, and the first two weeks the device is indicated for 24 hours a day, being removed only for eating and cleaning. At each visit clinical follow-up, shall be established a gradual reduction in the time of use so that the last three weeks of treatment are achieved 8h/day use.
- Control Group Intervention The non-occlusive splint (placebo) will also be made by the same dental technician. They differ by the plates did not interfere with the occlusal tooth gear, i.e., do not alter the position of closing jaws. As not lead acrylic on the occlusal surfaces of teeth, adequate retention is given by an arch wire in orthodontic buccal surface of teeth. They are adjusted based on the verification of the occlusion, so that the card does not interfere with movements or maximum intercuspation excursive lateral and protrusion, so that only the patient's teeth come into contact, without interference from the resin and the acrylic staple . The assessment of these patients occur at the same intervals recommended for patients in the experimental group being established on the same treatment protocol with respect to the daily use of the plate.
- In this study, all patients (study and control group) will undergo a counseling approach/self-care. Patients receive oral and written instructions about self-care, including, in addition to instructions on their condition of TMD and an explanation of the possible factors that contribute to the etiology of the same. The program also includes self-care guidelines on the use of moist heat or ice, use of soft diet, reduction of parafunctional habits (such as clenching and grinding your teeth or chewing gum), holding the rest of the postural position of the jaw (teeth apart , lips and tongue touching slightly pushing the front teeth), performing simultaneous bilateral chewing and modify posture to sleep. This approach will be reinforced verbally at each subsequent session.
- Being tested
- stabilizing appliance, Non-occluding splint, counseling
- Keywords
- Temporomandibular joint disorders, Stress psychological, Depression, Quality of Life
- Medical subject headings
- Temporomandibular Joint Disorders, Stress, Psychological, Musculoskeletal Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stabilizing applianceProcedure or surgery
Also called Occlusal stabilization appliance, Oral splints, Stabilization splint theraphy
The reversible occlusal therapy be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. The patients will be assessed at weekly intervals (between the query and the following board installation) and then biweekly during the period of 90 days. There shall be a gradual reduction in the daily use of the plate, and the first two weeks the device is indicated for 24 hours a day, being removed only for eating and cleaning. At each visit clinical follow-up, shall be established a gradual reduction in the time of use so that the last three weeks of treatment are achieved 8h/day use.
Non-occluding splint, counselingProcedure or surgery
Also called Splint control, Nonsplint therapy
The non-occlusive splint (placebo) will also be made by the same dental technician. They did not interfere with the occlusal tooth gear, ie, do not alter the position of closing jaws. They are adjusted based on the verification of the occlusion, so that the card does not interfere with movements or maximum intercuspation excursive lateral and protrusion, so that only the patient's teeth come into contact, without interference from the resin and the acrylic staple . The assessment of these patients occur at the same intervals recommended for patients in the experimental group being established on the same treatment protocol with respect to the daily use of the splint.
| Study group | Role | What they receive |
|---|---|---|
| Oral stabilization appliance,counselling | Experimental | The reversible occlusal therapy by stabilizing appliance used by patients in Study Group shall be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. Patients receive oral and written instructions about self-care (counseling), including, in addition to instructions on their condition of TMD and an explanation of the possible factors that contribute to the etiology of the same. Receives: Procedure: stabilizing appliance |
| Non-occluding splint, counselling | Placebo comparator | The non-occlusive splint (placebo) will also be made by the same dental technician. They differ by the plates did not interfere with the occlusal tooth gear, ie, do not alter the position of closing jaws. As not lead acrylic on the occlusal surfaces of teeth, adequate retention is given by an arch wire in orthodontic buccal surface of teeth. All patients will submitted a counseling approach / self-care. Patients receive oral and written instructions about self-care, including, in addition to instructions on their condition of TMD and an explanation of the possible factors that contribute to the etiology of the same. Receives: Procedure: Non-occluding splint, counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of physical symptoms
The measurement of spontaneous orofacial pain intensity will be obtained through the Visual Analogue Scale (VAS). Evaluated before and after three months of interventions, will be obtained from the average intensity of pain experienced by each group. The evolution of physical symptoms reported in each group will verify the effectiveness of interventions instituted in each group.
Measured: Participants will be monitored during the study period to assess changes in physical symptoms at 12 weeks.
Assessment of Quality of Life related to TMD
The comparison of scores in the two periods indicate a possible change in the index of quality of life. The instrument used for this will be the profile of the Oral Health Impact (OHIP-14).
Measured: Participants will be monitored during the study period to assess changes in quality of life in 12 weeks
Secondary outcomes (1)
Evaluation of psycho-emotional aspects related to the TMD
The Diagnostic Criteria for Research of temporomandibular disorders (RDC / TMD, Axis II)will be used. To assess the impact of psycho TMD, we investigate measures of depression and nonspecific physical symptoms accompanied by pain (somatization).
Measured: The psycho-emotional aspects will be evaluated before and after the intervention period of three months (12 weeks) to initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patra-cia Rocha Coelho
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Juiz de Fora
- Responsible party
- Sponsor-investigator, Patra-cia Rocha Coelho, Federal University of Juiz de Fora
- Investigators
- Patricia R. Coelho, Master, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544439
- Sponsor's protocol ID
- UTN: U111-1128-3875
- Other IDs
- 0183.0.180.000-11, 199/2011
- Status last verified
- Mar 2012
- First submitted
- 23 Feb 2012
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alencar F Jr, Becker A. Evaluation of different occlusal splints and counselling in the management of myofascial pain dysfunction. J Oral Rehabil. 2009 Feb;36(2):79-85. doi: 10.1111/j.1365-2842.2008.01913.x. Epub 2008 Oct 22.
PubMed 18976268Dao TTT, Lavigne GJ, Charbonneau A, Feine JS, Lund JP. The efficacy of oral splints in the treatment of myofascial pain of the jaw muscles: a controlled clinical trial. Pain. 1994 Jan;56(1):85-94. doi: 10.1016/0304-3959(94)90153-8.
PubMed 8159444De Laat A, Stappaerts K, Papy S. Counseling and physical therapy as treatment for myofascial pain of the masticatory system. J Orofac Pain. 2003 Winter;17(1):42-9.
PubMed 12756930Ekberg E, Vallon D, Nilner M. The efficacy of appliance therapy in patients with temporomandibular disorders of mainly myogenous origin. A randomized, controlled, short-term trial. J Orofac Pain. 2003 Spring;17(2):133-9.
PubMed 12836501Jokstad A, Mo A, Krogstad BS. Clinical comparison between two different splint designs for temporomandibular disorder therapy. Acta Odontol Scand. 2005 Aug;63(4):218-26. doi: 10.1080/00016350510019982.
PubMed 16040444Riley JL 3rd, Myers CD, Currie TP, Mayoral O, Harris RG, Fisher JA, Gremillion HA, Robinson ME. Self-care behaviors associated with myofascial temporomandibular disorder pain. J Orofac Pain. 2007 Summer;21(3):194-202.
PubMed 17717958Truelove E, Huggins KH, Mancl L, Dworkin SF. The efficacy of traditional, low-cost and nonsplint therapies for temporomandibular disorder: a randomized controlled trial. J Am Dent Assoc. 2006 Aug;137(8):1099-107; quiz 1169. doi: 10.14219/jada.archive.2006.0348.
PubMed 16873325Wright E, Anderson G, Schulte J. A randomized clinical trial of intraoral soft splints and palliative treatment for masticatory muscle pain. J Orofac Pain. 1995 Spring;9(2):192-9.
PubMed 7488989
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Occlusal Stabilization Appliance Associated to Counseling in the Management of Myofascial Pain Chronic and in the Improvement of the Quality of Life of Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT01544439
- Acronym / sponsor ID
- UTN: U111-1128-3875
- Keywords
- Temporomandibular joint disorders, Stress psychological, Depression, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Patra-cia Rocha CoelhoUniversity, hospital or other
- Collaborators
- Federal University of Juiz de Fora
- Study start
- Mar 2012
- Primary completion
- May 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 6 Mar 2012 (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 aim of this study was to evaluate the effectiveness of the splint occlusal associated with counseling in reducing pain in patients with temporomandibular disorders, under the assumption that the occlusal appliance offers the highest rates of improvement than their placebo.
Detailed description
- The aim of this double-blind randomized control trial was to evaluate the efficacy of occlusal stabilization appliance associated to counseling in the management of myofascial pain chronic and in the improvement of the quality of life of patients with temporomandibular disorders (TMD).
- In order to reduce the likelihood of systematic errors and allow the use of statistical tests is used randomization processes or randomization of the volunteers in the different groups from a sequence generated by a specific program (Randomization.com), and the principal investigator masked for this division. For this, a second researcher, appointed to undertake the division of patients into groups that maintain confidential information from groups and their participants, revealing only the researcher therapist at the time of first therapy session. The number of individuals randomized to the experimental group will be equal to the control group.
- Study Group Intervention The reversible occlusal therapy by stabilizing appliance used by patients in Study Group shall be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. The patients will be assessed at weekly intervals (between the query and the following board installation) and then biweekly during the period of 90 days. There shall be a gradual reduction in the daily use of the plate, and the first two weeks the device is indicated for 24 hours a day, being removed only for eating and cleaning. At each visit clinical follow-up, shall be established a gradual reduction in the time of use so that the last three weeks of treatment are achieved 8h/day use.
- Control Group Intervention The non-occlusive splint (placebo) will also be made by the same dental technician. They differ by the plates did not interfere with the occlusal tooth gear, i.e., do not alter the position of closing jaws. As not lead acrylic on the occlusal surfaces of teeth, adequate retention is given by an arch wire in orthodontic buccal surface of teeth. They are adjusted based on the verification of the occlusion, so that the card does not interfere with movements or maximum intercuspation excursive lateral and protrusion, so that only the patient's teeth come into contact, without interference from the resin and the acrylic staple . The assessment of these patients occur at the same intervals recommended for patients in the experimental group being established on the same treatment protocol with respect to the daily use of the plate.
- In this study, all patients (study and control group) will undergo a counseling approach/self-care. Patients receive oral and written instructions about self-care, including, in addition to instructions on their condition of TMD and an explanation of the possible factors that contribute to the etiology of the same. The program also includes self-care guidelines on the use of moist heat or ice, use of soft diet, reduction of parafunctional habits (such as clenching and grinding your teeth or chewing gum), holding the rest of the postural position of the jaw (teeth apart , lips and tongue touching slightly pushing the front teeth), performing simultaneous bilateral chewing and modify posture to sleep. This approach will be reinforced verbally at each subsequent session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral stabilization appliance,counselling | Experimental | Procedure: stabilizing applianceThe reversible occlusal therapy by stabilizing appliance used by patients in Study Group shall be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. Patients receive oral and written instructions about self-care (counseling), including, in addition to instructions on their condition of TMD and an explanation of the possible factors that contribute to the etiology of the same. |
| Non-occluding splint, counselling | Placebo comparator | Procedure: Non-occluding splint, counselingThe non-occlusive splint (placebo) will also be made by the same dental technician. They differ by the plates did not interfere with the occlusal tooth gear, ie, do not alter the position of closing jaws. As not lead acrylic on the occlusal surfaces of teeth, adequate retention is given by an arch wire in orthodontic buccal surface of teeth. All patients will submitted a counseling approach / self-care. Patients receive oral and written instructions about self-care, including, in addition to instructions on their condition of TMD and an explanation of the possible factors that contribute to the etiology of the same. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All subjects participated in this study volunteers by signing the consent form. Inclusion criteria are as follows:
- female subjects;
- aged 20 to 55 years;
- irrespective of race, social status or religion;
- presence of pain intensity of at least moderate (at least 4.0 on VAS), shown in the first clinical assessment;
Key exclusion criteria (11 listed)
- history of psychiatric disorders or treatment for neurological or psychological disorders;
- volunteers with severe intellectual or physical disability that would hinder the collection of data;
- history of systemic diseases that generate joint symptoms, muscle or rheumatologic, such as rheumatoid arthritis and fibromyalgia;
- pain attributed to a well-defined local cause, such as pulpitis, trigeminal neuralgia and cancer pain;
- attributable to migraine pain or infection;
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 |
|---|---|---|
| stabilizing applianceAlso: Occlusal stabilization appliance, Oral splints, Stabilization splint theraphyThe reversible occlusal therapy be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. The patients will be assessed at weekly intervals (between the query and the following board installation) and then biweekly during the period of 90 days. There shall be a gradual reduction in the daily use of the plate, and the first two weeks the device is indicated for 24 hours a day, being removed only for eating and cleaning. At each visit clinical follow-up, shall be established a gradual reduction in the time of use so that the last three weeks of treatment are achieved 8h/day use. | Procedure or surgery | Oral stabilization appliance,counselling |
| Non-occluding splint, counselingAlso: Splint control, Nonsplint therapyThe non-occlusive splint (placebo) will also be made by the same dental technician. They did not interfere with the occlusal tooth gear, ie, do not alter the position of closing jaws. They are adjusted based on the verification of the occlusion, so that the card does not interfere with movements or maximum intercuspation excursive lateral and protrusion, so that only the patient's teeth come into contact, without interference from the resin and the acrylic staple . The assessment of these patients occur at the same intervals recommended for patients in the experimental group being established on the same treatment protocol with respect to the daily use of the splint. | Procedure or surgery | Non-occluding splint, counselling |
Primary outcome
Evaluation of physical symptoms
Time frame: Participants will be monitored during the study period to assess changes in physical symptoms at 12 weeks.
The measurement of spontaneous orofacial pain intensity will be obtained through the Visual Analogue Scale (VAS). Evaluated before and after three months of interventions, will be obtained from the average intensity of pain experienced by each group. The evolution of physical symptoms reported in each group will verify the effectiveness of interventions instituted in each group.
Assessment of Quality of Life related to TMD
Time frame: Participants will be monitored during the study period to assess changes in quality of life in 12 weeks
The comparison of scores in the two periods indicate a possible change in the index of quality of life. The instrument used for this will be the profile of the Oral Health Impact (OHIP-14).
1 secondary outcome
Evaluation of psycho-emotional aspects related to the TMD
Time frame: The psycho-emotional aspects will be evaluated before and after the intervention period of three months (12 weeks) to initiation of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
- Results publication: PubMed 18976268Alencar F Jr, Becker A. Evaluation of different occlusal splints and counselling in the management of myofascial pain dysfunction. J Oral Rehabil. 2009 Feb;36(2):79-85. doi: 10.1111/j.1365-2842.2008.01913.x. Epub 2008 Oct 22.
- Results publication: PubMed 8159444Dao TTT, Lavigne GJ, Charbonneau A, Feine JS, Lund JP. The efficacy of oral splints in the treatment of myofascial pain of the jaw muscles: a controlled clinical trial. Pain. 1994 Jan;56(1):85-94. doi: 10.1016/0304-3959(94)90153-8.
- Results publication: PubMed 12756930De Laat A, Stappaerts K, Papy S. Counseling and physical therapy as treatment for myofascial pain of the masticatory system. J Orofac Pain. 2003 Winter;17(1):42-9.
- Results publication: PubMed 12836501Ekberg E, Vallon D, Nilner M. The efficacy of appliance therapy in patients with temporomandibular disorders of mainly myogenous origin. A randomized, controlled, short-term trial. J Orofac Pain. 2003 Spring;17(2):133-9.
- Results publication: PubMed 16040444Jokstad A, Mo A, Krogstad BS. Clinical comparison between two different splint designs for temporomandibular disorder therapy. Acta Odontol Scand. 2005 Aug;63(4):218-26. doi: 10.1080/00016350510019982.
- Results publication: PubMed 17717958Riley JL 3rd, Myers CD, Currie TP, Mayoral O, Harris RG, Fisher JA, Gremillion HA, Robinson ME. Self-care behaviors associated with myofascial temporomandibular disorder pain. J Orofac Pain. 2007 Summer;21(3):194-202.
- Results publication: PubMed 16873325Truelove E, Huggins KH, Mancl L, Dworkin SF. The efficacy of traditional, low-cost and nonsplint therapies for temporomandibular disorder: a randomized controlled trial. J Am Dent Assoc. 2006 Aug;137(8):1099-107; quiz 1169. doi: 10.14219/jada.archive.2006.0348.
- Results publication: PubMed 7488989Wright E, Anderson G, Schulte J. A randomized clinical trial of intraoral soft splints and palliative treatment for masticatory muscle pain. J Orofac Pain. 1995 Spring;9(2):192-9.
- Page SISNEP where they found information about the submission and approval of the study to the Platform Brazil - the Ethics in Human Research - Dean of Research / UFJFLink provided by the sponsor.
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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.
Patricia R. Coelho, Master principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stabilizing appliance and Non-occluding splint, counseling in people with Temporomandibular Disorders and Stress Psychological, run by Patra-cia Rocha Coelho at 1 site in Brazil.
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 11 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: status not confirmed, as of the sponsor's last update on 17 May 2012. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia R. Coelho, Master ((32) 0032-1100, patriciacoelho.odonto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of physical symptoms (time frame: Participants will be monitored during the study period to assess changes in physical symptoms at 12 weeks.). The study lists 2 primary outcomes in all. 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 NCT01544439, which also lists 8 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 17 May 2012.