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Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.

ABSTRACT: Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin.A randomized controlled clinical trial will be conducted. It will involve 60 women ? 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay.This is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures.ClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.

SUBMITTER: da Silva MM

PROVIDER: S-EPMC4464876 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.

da Silva Mariana Moreira MM Albertini Regiane R Leal-Junior Ernesto Cesar Pinto EC de Tarso Camillo de Carvalho Paulo P Silva José Antonio JA Bussadori Sandra Kalil SK de Oliveira Luis Vicente Franco LV Casarin Cezar Augusto Souza CA Andrade Erinaldo Luiz EL Bocalini Danilo Sales DS Serra Andrey Jorge AJ

Trials 20150604

<h4>Background</h4>Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy wit ...[more]

PMID: 26040789

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Project description:BackgroundTemporomandibular disorder (TMD) is the most common cause of orofacial and cervical skull pain and is considered to be a public health problem, affecting 5% to 12% of the world population. TMD is multifactorial and there are several types of treatment, with the conservative types being indicated more often as they are less aggressive and reversible. The main aim of these treatments is to relieve symptoms, reduce of pain, and restore orofacial and cervical skull functions. Photobiomodulation therapy (PBMT), a noninvasive therapy, is an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects.MethodsThe aim of the proposed study is to verify whether PBMT is effective for use in palliative care of TMD and orofacial and cervical skull pain. A randomized, triple-blinded, placebo-controlled clinical trial is proposed. This study will involve 200 adult participants (over 18 years of age) who will be randomly divided into two groups (n = 100): Group 1, active treatment (PBMT); and Group 2, placebo. Participants will be subjected to three sessions of PBMT or placebo and will be evaluated using the research diagnostic criteria (RDC) for TMD. Pain level (measured by a visual analog scale (VAS)), mandibular movements (measured by ruler and caliper), quality of life (measured by the Oral Health Impact Profile (OHIP)-14), and quality of sleep (measured by the Epworth scale) will be recorded. This study is being conducted at the Special Laboratory of Lasers in Dentistry (LELO) of the School of Dentistry of the University of Sao Paulo (USP).DiscussionThis study will verify whether PBMT is effective in reducing TMD and orofacial and cervical skull pain. PBMT may be an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects, in addition to being a noninvasive technique.Trial registrationRegistro Brasileiro de Ensaios Clínicos, RBR-9b6mnj . Registered on 27 March 2018. Trial registry name: Laser de baixa potência no cuidado paliativo da disfunção temporomandibular e dor crânio orofacial e cervical. Ethics committee: #1774930 approved on 14 October 2016.

Project description:BackgroundFibromyalgia (FM) affects approximately 1-3 % of the general population. Fatigue limits the work ability and social life of patients with FM. A few studies of physical exercise have included measures of fatigue in FM, indicating that exercise can decrease fatigue levels. There is limited knowledge about the effects of resistance exercise on multiple dimensions of fatigue in FM. The present study is a sub-study of a multicenter randomized controlled trial in women with FM. The purpose of the present sub-study was to examine the effects of a person-centered progressive resistance exercise program on multiple dimensions of fatigue in women with FM, and to investigate predictors of the potential change in fatigue.MethodsA total of 130 women with FM (age 22-64 years) were included in this assessor-blinded randomized controlled multicenter trial examining the effects of person-centered progressive resistance exercise compared with an active control group. The intervention was performed twice a week for 15 weeks. Outcomes were five dimensions of fatigue measured with the Multidimensional Fatigue Inventory (MFI-20). Information about background was collected and the women also completed several health-related questionnaires. Multiple linear stepwise regression was used to analyze predictors of change in fatigue in the total population.ResultsA higher improvement was found at the post-treatment examination for change in the resistance exercise group, as compared to change in the active control group in the MFI-20 subscale of physical fatigue (resistance group Δ -1.7, SD 4.3, controls Δ 0.0, SD 2.7, p = 0.013), with an effect size of 0.33. Sleep efficiency was the strongest predictor of change in the MFI-20 subscale general fatigue (beta = -0.54, p = 0.031, R (2) = 0.05). Participating in resistance exercise (beta = 1.90, p = 0.010) and working fewer hours per week (beta = 0.84, p = 0.005) were independent significant predictors of change in physical fatigue (R (2) = 0.14).ConclusionsPerson-centered progressive resistance exercise improved physical fatigue in women with FM when compared to an active control group.Trial registrationClinicalTrials.gov NCT01226784 . Registered 21 October 2010.

Project description:BackgroundAccording to the International Association for the Study of Pain (IASP), the term temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck on one or both sides, as well as joint sounds, limited mandibular movements or mandibular deviation and difficulties chewing. Phototherapy, such as low-level laser therapy (LLLT) and light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain. Thus, there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (LLLT and LED) in the same apparatus. The aim of the proposed study is to evaluate the effects of four different doses of phototherapy on pain, activity of the masticatory muscles (masseter and bilateral anterior temporal) and joint mobility in individuals with temporomandibular disorder. A further aim is to determine the cumulative effect 24 and 48 hours after a single session.Methods/designA placebo-controlled, double-blind, randomized, clinical trial will be carried out involving 72 women between 18 and 40 years of age with a diagnosis of myogenous TMD. The participants will then be randomly allocated to four groups totaling 18 individuals per group. Three groups will be submitted to a single session of phototherapy with different light sources, and one group will receive placebo therapy: Group A (2.62 Joules); Group B (5.24 Joules); Group C (7.86 Joules); and Group D (0 Joules). The following assessment tools will be administered on four separate occasions (baseline and immediately after, 24 h after and 48 h after phototherapy). Pain intensity will be assessed using the visual analog scale for pain, while pain thresholds will be determined using algometer, and electromyographic (EMG) analysis on the masseter and anterior temporal muscles.DiscussionThe study will contribute to the practice of the evidence-based use of phototherapy in individuals with a myogenous TMD. Data will be published after the study is completed.Trial registrationThis study is registered with the Brazilian Registry of Clinical Trials, NCT02018770, date of registration: 7 December 2013.

Project description:INTRODUCTION:Temporomandibular disorder (TMD) is considered the main cause of orofacial pain of non-dental origin, and a public health problem. The symptomatology is muscular and/or articular pain, restriction of the mandibular range of motion, and changes in the mandibular movement pattern. Due to its complexity there are already treatments using various forms of therapy. Photobiomodulation using light sources, such as low-level laser or light emitting diodes (LED), with different wavelengths, in a single or combined form, allows one more therapeutic resource to be explored. The objective of this study is to evaluate the effects of photobiomodulation with the simultaneous use of red and infrared LEDs, on pain, range of mandibular movements, and on the electrical activity of masticatory muscles in individuals with TMD. METHODS:A randomized, controlled, double-blind clinical trial is proposed, which will involve 33 individuals (n?=?11 per group) of both sexes, ages 18 to 45 years in 3 groups: LED group; placebo group; and control group, submitted to 6 non-consecutive sessions of photobiomodulation totaling 2 weeks of treatment. The Research Diagnostic Criteria for Temporomandibular Disorders-RDC/TMD will be used to assess and determine the participants' TMD. The pain will be assessed using the Visual Analog Scale - VAS, the mandibular range of motion will be determined with the aid of a digital caliper, and the electrical activity of the masticatory muscles will be verified by electromyography. A mixed plate of 18 red LEDs-660?nm and 18 infrared LEDs-850?nm with power of 3.5?mW per LED, 4.45?mW/cm, radiant exposure of 5.35?J/cm, will be used for photobiomodulation. The irradiated area will be 14.13?cm, and energy of 75.6?J, in the TMJ region and in the bilateral masseter and temporal muscles. Participants from all groups will be reassessed after the first therapeutic intervention, and at the end of treatment. DISCUSSION:We expect the use of photobiomodulation with LEDs, infra and red, to reduce pain, improve temporomandibular joint function in patients with TMD, and thus improve the general conditions of the patient.

Dataset Information

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.

Publications

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.

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