BMS is most often seen in women and is more frequent during menopause. The etiology and pathogenesis are still unclear but recent studies suggest that BMS is a neuropathic pain condition. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort.
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Neurogenic Mechanisms in Burning Mouth Syndrome BMS17 The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : March 14, Study Description. The objectives of the study are: To clarify potential neurogenic mechanisms behind BMS using immunohistochemistry IH to characterize the localization and distribution of peripheral nerve fibres, neuropeptides like substance P, calcitonin gene-related peptide, nerve growth factor, nerve growth factor receptor, PGP 9.
Differences were considered significant if p was less than 0. One clinician collected the Visual Analogue Scale and the questionnaires fulfilled by the patients and another clinician applied the laser treatment. Laser, Italy turned off with an application time per point of 10 seconds in 56 points 3 in the vestibular mucosa of the 4 quadrants, 6 in each of the two buccal mucosa, 6 in the hard palate, 4 in each lateral of the tongue, 6 in the dorsum of the tongue and 4 sublingual points with a distance between points of 2mm.
Secondary Outcome Measures : Description of Pain: Mc Gill Pain Questionnaire validated to Spanish [ Time Frame: Baseline day 1 , Session 10 day 32 , 1st month follow-up day 60 , 4th month follow-up day ] The patient is provided with a form comprising instructions and 20 word groups.
The patient should circle one word in the group, which describes their pain. If there is no word in the group, which describes their pain, they are to move on to the next group until they have completed each of the 20 groups.
Groups 1 to 10 are words used to describe sensory experience, groups 11 to 15 are affective words, 16 is evaluative and 17 to 20 are miscellaneous groups. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Effects of Photobiomodulation in Burning Mouth Syndrome The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : July 26, Study Description. The main objective of this study is to assess the effects of Photobiomodulation with Low-level Laser Therapy to the pain management in Burning Mouth Syndrome patients, besides assessing their impact on the different aspects of their quality of life, using the necessary questionnaires to evaluate all the outcomes of chronic pain.
Show detailed description. Hide detailed description. Detailed Description:. Blinding was revealed after all participants finished the trial, and all the data were analyzed Statistical methods All the analysis was done using SPSS version FDA Resources. Arms and Interventions. Outcome Measures. Primary Outcome Measures : Changes in Visual Analogue Scale for Pain [ Time Frame: Baseline day 1 , Session2 day 4 , Session 3 day 8 , Session 4 day 11 , Session 5 day 15 , Session 6 day 18 , Session 7 day 22 , Session 8 day 25 , Session 9 day 29 , Session 10 day 32 , 1st month follow-up day 60 , 4th month follow-up day ] Pain was assessed using a Visual Analogue Scale cm by the patients before starting each session and at two follow-up sessions, 1 and 4 months after finishing the treatment.
The SF consists of eight scaled scores, which are the weighted sums of the questions in their section. After that, the patient will chose their preferred treatment and continue with that treatment for 6 months i. Drug: Clonazepam 0. Drug: Capsaicin Topical Topical treatment of oral mucosa with capsaicin rinse Other Name: Chili Placebo Comparator: Placebo Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day.
Will be assessed using the subscale "Characteristic pain intensity" three numerical rating scales 0 - 10 assessing current pain. Patient satisfaction [ Time Frame: Point measurement, will be assessed 10 days after treatment start for each treatment period. Patient satisfaction [ Time Frame: Point measurement, will be assessed the day after each treatment period is finished 22 days after start of each treatment ] Patient satisfaction with the treatment tested.
Secondary Outcome Measures : Pain-related disability [ Time Frame: Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.
Will be assessed using the subscale "Pain-related Disability" three numerical rating scales 0 - 10 assessing impact on the oral pain on general, social and work-related activities during the last two weeks in the Graded Chronic Pain Scale Eligibility Criteria Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials.
Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : September 28, See Contacts and Locations.
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