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Efficacy of Shiatsu in Individuals With Fibromyalgia: a Randomized Clinical Trial

NCT ID: NCT01291043

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Keywords

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Shiatsu Fibromyalgia Pain Quality of sleep Balance Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shiatsu Group

Group Type EXPERIMENTAL

Shiatsu

Intervention Type OTHER

8-week treatment with two Shiatsu sessions per week (50-minute duration)

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Shiatsu

8-week treatment with two Shiatsu sessions per week (50-minute duration)

Intervention Type OTHER

Other Intervention Names

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Acupressure

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susan Yuan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan LK Yuan, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine of the University of Sao Paulo

Amelia P Marques, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine of the University of Sao Paulo

Locations

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University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1297/09

Identifier Type: -

Identifier Source: org_study_id