Effects of Pain Therapeutic Education and Hydrotherapy on Physical Function, Pain and Sleep of Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia (FM) is a prevalent and disabling disease, that affects mostly women and its
      main characteristic is chronic pain. Several studies have shown that hydrotherapy is
      effective in the improvement of symptoms and quality of life of this population; other
      studies have shown that Pain Therapeutic Education (PTE) is also effective in this sense. PTE
      is one cheap, easy to apply intervention, with very positive results in chronic pain
      situations. However, there is a lack of studies that have shown the effects of this
      intervention on FM. Hence, this study will aim to verify the effectiveness of the
      hydrotherapy and PTE on women with FM. Sixty women will be randomly allocated in two groups:
      hydrotherapy and hydrotherapy + PTE. Before treatment start, the investigators will evaluate
      pain (visual analogue scale, presence of myofascial trigger points and pressure pain
      threshold over the scalene, upper trapezius, infraspinatus, piriformis, iliopsoas and soleus,
      bilaterally), quality of life (Fibromyalgia Impact Questionnaire and medical outcomes study
      36-item short-form health survey), depression (Beck Depression Inventory), anxiety (Beck
      Anxiety Inventory) and sleep quality (Pittsburgh Sleep Quality Index and Epworth Sleepiness
      Scale). Hydrotherapy treatment will last 12 weeks. Women will be evaluated other 3 times:
      after 6 and 12 weeks (treatment middle and end) and 12 weeks after treatment completion
      (follow-up). Women in the hydrotherapy group will receive a folder with explanations on FM.
      Women in the hydrotherapy + PTE will participate of 4 meetings over 12 treatment weeks, in
      which themes like pain physiology, pain chronification and exacerbation and pain
      self-management, as well as information on FM will be approached. Statistical analysis will
      include qualitative and quantitative variable description. Correlation among variables will
      also be analyzed. Level of significance will be set at 5%.
    

Detailed description: 
      The investigators will select at least 80 women with fibromyalgia (FM) for this study, in
      which pain (through pressure pain threshold and number of active myofascial trigger points),
      quality of life, FM impact on quality of life and function, depression, anxiety and quality
      of sleep will be evaluated.

      After evaluating the volunteer, the participant will be randomly allocated to one of two
      groups: hydrotherapy treatment (HT), and hydrotherapy treatment together with pain
      therapeutic education (HT+PTE).

      All volunteers will perform 12 weeks of hydrotherapy treatment, in which the investigators
      will perform global exercises for upper and lower limbs and trunk.

      Volunteers in the HT+PTE group will receive, throughout the 12 weeks of HT, 4 sessions of
      PTE, in which the investigators will teach pain neurophysiology, pain chronification and pain
      management.

      Evaluation sessions will take place before treatment, after 6 and 12 weeks of HT and after 12
      weeks of treatment ending.

      In all evaluations sessions, the investigators will collect data on those aspects previously
      described.
    

Intervention name(s): Pain Education; Hydrotherapy
Intervention type(s): Other; Other
Intervention description(s): Together with hydrotherapy, patients will receive pain therapeutic education; Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.
Other intervention name(s): Pain Neuroscience Education, Pain Therapeutic Education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized controlled trial with 1:1 allocation
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hydrotherapy; Pain education