Effect of vibration stimulus in fibromyalgia women

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-36d8nf
• Date of registration: 09/09/2016
• Prospective Registration: No
• Primary sponsor: Universidade Federal dos Vales do Jequitinhonha e Mucuri
• Public title: Effect of vibration stimulus in fibromyalgia women
• Scientific title: Acute effect of whole body vibration in neuro endocrine inflammatory parameters in fibromyalgia women
• Date of first enrolment: 30/03/2016
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-36d8nf
• Study type: Intervention
• Study design: Treatment / parallel / with two arms / open / prospective
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Ana Cristina Rodrigues Lacerda
• Affiliation: Universidade Federal dos Vales do Jequitinhonha e Mucuri

• Name: Vanessa Gonçalves César Ribeiro
• Affiliation: Universidade Federal dos Vales do Jequitinhonha e Mucuri

Key inclusion & exclusion criteria

Inclusion criteria: Fibromyalgia: present confirmed diagnosis of fibromyalgia by rheumatologist. According to the American College of Rheumatology for the characterization of the disease, the symptoms must persist for at least 3 months.
Control: not present rheumatic disease or serious general health changes and not be inserted in any physical activity program. These women were selected paired form (1:1) according to age and anthropometric variables with fibromyalgia group.
Exclusion criteria: being a smoker; drinking alcohol; make use of immunosuppressive medication; present any concomitant disease that can be exacerbated by physical activity; pregnancy; orthopedic impairments; respiratory and inflammatory diseases or cardiovascular diseases; be followed up with a psychiatrist, or perform physical activity for the same 2 times a week; Acute hernia; thrombosis; epilepsy; orthopedic injuries; prostheses. The above criteria were used for both groups.

Age minimum: 30Y
Age maximum: 68Y
Gender: F

Health Condition(s) or Problem(s) studied

Fibromyalgia

M79.7

Intervention(s)

This is a study with two groups, one consisting of women with FM and another for healthy asymptomatic women (control group), both groups received the intervention (whole body vibration stimulus). In the first session all volunteers were evaluated for physical function, work, well being, pain, quality of life, depression and sleep quality through the application of questionnaires: the FM impact questionnaire, visual analogue scale pain, quality of life questionnaire, Beck Inventory, Pittsburgh sleep quality index. In addition, it will evaluate the functional capacity of the lower limbs through the sit up from the chair test. Also in this session the participants were familiar with the whole body vibration stimulus on the vibration platform, adopting the position adopted during the trial session and received the vibratory stimulus for 40 seconds, to avoid interference in oxygen consumption and heart rate due to anxiety generated by performing a different exercise from conventional. In a second session we performed the experimental protocol consisted of stay for 10 minutes followed by performance of dynamic squat exercise on the vibratory platform (8 series of 40 seconds with 40 seconds of rest between sets. The frequency used was 40 Hz and amplitude of 4 mm (intensity 1). Before and immediately after this protocol, blood sample were collect, as well as measurement of blood pressure, and application of visual analogue pain scale and perceived exertion scale. For characterization of strength of the whole body vibration stimulus, after standing for at least 10 minutes to ensure return to the body homeostasis, the volunteers of both groups performed two vibration exercise protocol with an interval of at least 10 minutes between exercises. A portable gas analyzer was used to m

G01.374.676.930

Other

Primary Outcome(s)

Initially it was expected that women presented with fibromyalgia neuro-endocrine higher concentrations of inflammatory markers compared with asymptomatic women at rest. In addition, it was expected that the whole body vibration stimulus to reduce the concentration of these biomarkers demonstrating the beneficial effect of this intervention. That is, it was expected modulation of neuroendocrine-inflammatory parameters by acute exercise of whole body vibration and increased oxygen consumption and heart rate by acute exercise of whole body vibration.

After the study of end results showed that individuals with fibromyalgia have an "status inflammatory" inherent disease and acute stimulation of whole body vibration (low intensity and short duration), seem to be enough to cause interaction (disease versus stimulus) and thus, modulation of inflammatory markers in order to fit inflammation homeostasis. Also the acute stimulation of whole body vibration promoted an increase in oxygen consumption and heart rate in a manner similar between groups.

Secondary Outcome(s)

To characterize the sample it was expected that women with fibromyalgia presented lower scores compared with the group of asymptomatic women, the evaluated questionnaires, such as above 70 scores on the fibromyalgia impact questionnaire, rating depression by Depression Inventory Beck with scores above 20, more than 11 tender points, and worse performance in the test and sit up from his chair.

After the study results demonstrate that women with fibromyalgia have an average score of 75.58 on the impact questionnaire fibromyalgia. Ratings in this questionnaire above 70 on a scale of zero to 100 are considered severe impact of the disease. Regarding the Beck Depression Inventory showed a score of 22.10 and the women in the control group showed score 10.90. Scores above 17 are classified as having depression. Also women with fibromyalgia had an average of 14.1 points painful, since the women in the control group 0.85. It was also identified worst performance on the sit and up from a chair test of the fibromyalgia group with an average of 8 reps while asymptomatic women performed 12 repetitions on average.

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa de Minas Gerais

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa de Minas Gerais