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 MM, Albertini R, Leal-Junior EC, de Tarso Camillo de Carvalho P, Silva JA, Bussadori SK, de Oliveira LV, Casarin CA, Andrade EL, Bocalini DS, Serra AJ
Trials · 21 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Universidade Nove de Julho
- Gobierno
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2015-06-04 · Trials · vol. 16 · número 1 · pág. 252
- Editorial
- Springer Science+Business Media
- Citado
- 25 citas · más que el 76% de estudios similares · 1.0× el promedio de su campo
- Referencias
- 45 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Fibromyalgia and Chronic Fatigue Syndrome Research · Temporomandibular Joint Disorders · Myofascial pain diagnosis and treatment
- Palabras clave
- fibromyalgia, temporomandibular disorders, chronic pain, exercise training, low-level laser therapy, light-emitting diode phototherapy, serotonin, quality of life, women, pain threshold, facial exercises, muscle stretching exercises, aerobic exercise
- MeSH
- saliva, humans, temporomandibular joint disorders, fibromyalgia, serotonin, pain measurement, treatment outcome, clinical protocols, combined modality therapy, exercise therapy, equipment design, research design, time factors, quality of life, adult, brazil, female, lasers, semiconductor, biomarkers, surveys and questionnaires, low-level light therapy
11 autores
- Mariana Moreira da Silva🇧🇷 · autor de correspondenciaUniversidade Nove de Julho
- Regiane Albertini🇧🇷Universidade Nove de Julho
- Ernesto César Pinto Leal‐Junior🇧🇷Universidade Nove de Julho
- Paulo de Tarso Camillo de Carvalho🇧🇷Universidade Nove de Julho
- José Antônio Silva🇧🇷Universidade Nove de Julho
- Sandra Kalil Bussadori🇧🇷Universidade Nove de Julho
- Luís Vicente Franco de Oliveira🇧🇷Universidade Nove de Julho
- Cezar Augusto Souza Casarin🇧🇷Universidade Nove de Julho
- Erinaldo Andrade🇧🇷Universidade Nove de Julho
- Danilo Sales Bocalini🇧🇷Universidade Nove de Julho
- Andrey Jorge Serra🇧🇷Universidade Nove de Julho
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
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.
Methods/design
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.
Discussion
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.
Trial registration
ClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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