PainFM and DTMNCT02279225
Protocol Phototherapy Treatment for Fibromyalgia and Temporomandibular Joint Dysfunction
A study testing Group Phototherapy, Phototherapy + Physical activity and Physical activity in people with Pain and Quality of Life, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Temporomandibular joint dysfunction is described as a multifactorial disease and can be directly linked to other diseases, being of structural factors of the Stomatognathic System or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular Dysfunctions with fibromyalgia. Read more about this study
- Who is it for?
- Ages 35 to 58 years, women only
- Conditions the study is for
- Pain, Quality of Life
- What is being tested?
- Group Phototherapy, Phototherapy + Physical activity and Physical activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Dec 2015
- 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 35 to 58 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology;
- Clinical diagnosis of TMD by the RDC questionnaire (annex I);
- Cognitive Level enough to understand the procedures and follow the guidelines that will be passed;
- People who use drugs corresponding to Fibromyalgia (FM), antidepressant;
- Class I of angle
- Consent to participate in the study and sign the consent form post information.
Who cannot join
- With psychiatric disorders;
- Cognitive Changes;
- People who perform some exercise;
- People who carry out orthodontic treatment;
- Systemic diseases;
- Persons under the age of 35 and more than 58 years.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Mariana Moreira Da Silva
São Caetano do Sul, São Paulo, 09560500
MARIANA MOREIRA D SILVA, +5511992248813
About this study
Official title: RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Temporomandibular joint dysfunction is described as a multifactorial disease and can be directly linked to other diseases, being of structural factors of the Stomatognathic System or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a Randomized, Controlled and double-blind, with the intention to treat. In this way the sample of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT) group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy Group (FT + A). Will be used as a means of analysis before and after interventions the following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments will total in 10 sessions held twice a week, and the FT and FT + groups to receive Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered 39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic activity in 75% of your MHR for 50 min and the P group will receive the application of Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis will be compared using the t test intra-group-Student, one-tail and paired and can be used the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.
- Conditions
- Pain, Quality of Life
- Being tested
- Group Phototherapy, Phototherapy + Physical activity, Physical activity, Placebo
- Keywords
- Phototherapy, Laser, Fibromyalgia, DTM/ TMD, Pain
- Medical subject headings
- Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PhototherapyRadiation
Phototherapy + Physical activityRadiation
Physical activityOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| placebo (P) | Placebo comparator | Intervention without radiation Receives: Other: Placebo |
| phototherapy (FT) | Experimental | Intervention only with phototherapy radiation Receives: Radiation: Group Phototherapy |
| phototherapy+Physical activity (FT+A) | Experimental | Intervention associated Receives: Radiation: Phototherapy + Physical activity |
| Physical activity (A) | Experimental | Intervention with physical activity: the gold standard of treatment in fibromyalgia Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The time corresponds to assess changes: Assessed on the first day before the start of the first session and the reassessment is made after the last session, after half an hour of intervention. Assessed with questionnaires, and EVA, and algometry.
Measured: 10 sessions, in 5 weeks, 2 times a week
Secondary outcomes (2)
Quality of sleep
The time corresponds to assess changes: Performs initial assessment a week before the first session and the revaluation performs after a week of the last session. evaluation with polysomnography
Measured: before and after: 10 sessions in 5 weeks, 2 times a week
Quality of life
The time corresponds to assess changes: Assessed on the first day before the start of the first session and the reassessment is made after the last session, after half an hour of intervention. Assessed with questionnaires.
Measured: 10 sessions, in 5 weeks, 2 times a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Mariana Moreira da Silva, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279225
- Sponsor's protocol ID
- y4tma2ef
- Acronym
- FM and DTM
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2014
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
da Silva MM, Albertini R, Leal-Junior EC, de Tarso Camillo de Carvalho P, Silva JA Jr, Bussadori SK, de Oliveira LV, Casarin CA, Andrade EL, Bocalini DS, Serra AJ. Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial. Trials. 2015 Jun 4;16:252. doi: 10.1186/s13063-015-0765-3.
PubMed 26040789
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
- ClinicalTrials.gov ID
- NCT02279225
- Acronym / sponsor ID
- FM and DTM / y4tma2ef
- Conditions
- Pain, Quality of Life
- Keywords
- Phototherapy, Laser, Fibromyalgia, DTM/ TMD, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Oct 2014 (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.
Temporomandibular joint dysfunction is described as a multifactorial disease and can be directly linked to other diseases, being of structural factors of the Stomatognathic System or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a Randomized, Controlled and double-blind, with the intention to treat. In this way the sample of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT) group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy Group (FT + A). Will be used as a means of analysis before and after interventions the following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments will total in 10 sessions held twice a week, and the FT and FT + groups to receive Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered 39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic activity in 75% of your MHR for 50 min and the P group will receive the application of Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis will be compared using the t test intra-group-Student, one-tail and paired and can be used the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo (P) | Placebo comparator | Other: PlaceboIntervention without radiation |
| phototherapy (FT) | Experimental | Radiation: Group PhototherapyIntervention only with phototherapy radiation |
| phototherapy+Physical activity (FT+A) | Experimental | Radiation: Phototherapy + Physical activityIntervention associated |
| Physical activity (A) | Experimental | Other: Physical activityIntervention with physical activity: the gold standard of treatment in fibromyalgia |
Who may qualify
- Ages
- 35 to 58 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology;
Key exclusion criteria (6 listed)
- With psychiatric disorders;
- Cognitive Changes;
- People who perform some exercise;
- People who carry out orthodontic treatment;
- Systemic 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 |
|---|---|---|
| Group Phototherapy | Radiation | phototherapy (FT) |
| Phototherapy + Physical activity | Radiation | phototherapy+Physical activity (FT+A) |
| Physical activity | Other | Physical activity (A) |
| Placebo | Other | placebo (P) |
Primary outcome
Pain
Time frame: 10 sessions, in 5 weeks, 2 times a week
The time corresponds to assess changes: Assessed on the first day before the start of the first session and the reassessment is made after the last session, after half an hour of intervention. Assessed with questionnaires, and EVA, and algometry.
2 secondary outcomes
Quality of sleep
Time frame: before and after: 10 sessions in 5 weeks, 2 times a week
Quality of life
Time frame: 10 sessions, in 5 weeks, 2 times a week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Derived from this study: PubMed 26040789da Silva MM, Albertini R, Leal-Junior EC, de Tarso Camillo de Carvalho P, Silva JA Jr, Bussadori SK, de Oliveira LV, Casarin CA, Andrade EL, Bocalini DS, Serra AJ. Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial. Trials. 2015 Jun 4;16:252. doi: 10.1186/s13063-015-0765-3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Phototherapy, Phototherapy + Physical activity and Physical activity in people with Pain and Quality of Life, run by University of Nove de Julho 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 6 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 15 Dec 2015. 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.
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 Mariana Moreira da Silva55011 (55 011 992248813, fisioterapeutamariana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 10 sessions, in 5 weeks, 2 times a week). 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 NCT02279225, which also lists 1 linked publication.
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 15 Dec 2015.