Efficacy of Shiatsu in Individuals With Fibromyalgia: a Randomized Clinical Trial
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is a syndrome characterized by chronic and generalized musculoskeletal pain and
      tenderness in tender points. Its etiology and physiopathology are not well known; therefore
      its treatment is not satisfactory. Having this in view, a search for alternative and
      complementary medicine has been going on. This kind of practice is under pressure to present
      evidences of efficacy. A randomized clinical trial will be carried out with the aim of
      verifying the efficacy of a massage technique called Shiatsu in the improvement of pain,
      flexibility, quality of sleep, anxiety and quality of life of individuals with fibromyalgia.
      A sample of 34 subjects will be divided in Shiatsu Group and Control Group. All subjects will
      be evaluated in the beginning, in the middle and at the end of the treatment. Pain will be
      evaluated by the following instruments: visual analogue scale (VAS) and dolorimetry. The
      V-sit and reach test (VSRT) will be used to assess the flexibility of the hamstring muscles
      and lower back. The sleep will be evaluated with the Pittsburgh Sleep Quality Index (PSQI).
      The State-Trait Anxiety Inventory (STAI) will be used to evaluate anxiety. The evaluation of
      quality of life will be made with two instruments: fibromyalgia impact questionnaire (FIQ)
      and Activities-specific Balance Confidence (ABC) scale. In each treatment session, the
      subjects will be globally evaluated in the 14 main meridians and their respective points by
      touch, identifying points of excessive energy and their severity. The Control Group will wait
      for treatment and remain only with conventional pharmacological treatment, while the Shiatsu
      Group will receive a treatment with Shiatsu during eight weeks. The results will be expressed
      in mean and standard deviation. The normality of the data will be verified by the
      Shapiro-Wilk test. In the intragroup analysis, the T-test for the parametric data and the
      Wilcoxon test for the nonparametric data. In the comparison between groups, the analysis of
      variance (ANOVA) test will be used. The level of significance adopted will be α < 0.05.
    

Detailed description: 
      In the VAS, the subject marks the intensity of its pain in a 10 centimeter horizontal line.

      In dolorimetry, the pain thresholds (PT) of 18 tender points are measured with the
      dolorimeter.

      The VSRT assesses the flexibility mainly of the hamstring muscles and also of the lower back.

      The PSQI is constituted of 19 questions. Scores of five or more indicate bad sleep quality
      and sleep disturbances.

      The STAI is composed of two scales of items with semantic content which expresses the absence
      or presence of anxiety. Higher scores obtained in each scale indicate higher levels of
      anxiety.

      The FIQ is composed of ten items. Higher scores indicate higher impact of fibromyalgia over
      quality of life The ABC scale was translated and adapted for this study and consists of a
      17-item scale in which the level of confidence in balance is indicated in the execution of
      diverse activities.
    

Intervention name(s): Shiatsu
Intervention type(s): Other
Intervention description(s): 8-week treatment with two Shiatsu sessions per week (50-minute duration)
Other intervention name(s): Acupressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shiatsu; Fibromyalgia; Pain; Quality of sleep; Balance; Quality of life