Clinical trial NCT01291043: Efficacy of Shiatsu in Individuals With Fibromyalgia: a Randomized Clinical Trial
Official title: Efficacy of Shiatsu in Pain, Flexibility, Sleep, Anxiety and Quality of Life in Individuals With Fibromyalgia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Shiatsu
Fibromyalgia
Pain
Quality of sleep
Balance
Quality of life
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* diagnoses of fibromyalgia

Exclusion Criteria:

* diagnoses of diseases that cause chronic pain
* skin lesions and infection
* pregnancy
* two consecutive absences in treatment sessions
* use of psychotherapy, physiotherapy or complementary therapies in the last 6 months
* regular supervised physical activity

Primary outcomes:
measure: Change from baseline in VAS at 8 weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change from baseline in FIQ at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in PSQI at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in STAI at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in VSRT at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in FIQ at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in PSQI at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in STAI at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in VSRT at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in VAS at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in ABC scale at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in ABC scale at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline in PT mean at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from baseline in PT mean at 8 weeks
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: Faculty of Medicine of the University of Sao Paulo
name: Susan LK Yuan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine of the University of Sao Paulo
name: Amelia P Marques, PhD
role: STUDY_DIRECTOR
References: