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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan Yuan, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01291043
First received: January 27, 2011
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Fibromyalgia
Other: Shiatsu

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Shiatsu in Pain, Flexibility, Sleep, Anxiety and Quality of Life in Individuals With Fibromyalgia: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Change from baseline in VAS at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    In the VAS the subject marks the intensity of its pain in a 10 centimeter horizontal line


Secondary Outcome Measures:
  • Change from baseline in FIQ at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The FIQ is composed of ten items, in which higher scores indicate higher impact of fibromyalgia over quality of life

  • Change from baseline in PSQI at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The sleep will be evaluated with the PSQI, which is constituted of 19 questions. Scores of five or more indicate bad sleep quality and sleep disturbances.

  • Change from baseline in STAI at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The STAI will be used to evaluate anxiety. It is composed of two scales of items with semantic content which expresses the absence or presence of anxiety. Higher scores indicate higher levels of anxiety.

  • Change from baseline in VSRT at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The VSRT will be used to assess the flexibility mainly of the hamstring muscles and also of the lower back.

  • Change from baseline in FIQ at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The FIQ is composed of ten items, in which higher scores indicate higher impact of fibromyalgia over quality of life.

  • Change from baseline in PSQI at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The sleep will be evaluated with the PSQI, which is constituted of 19 questions. Scores of five or more indicate bad sleep quality and sleep disturbances.

  • Change from baseline in STAI at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The STAI will be used to evaluate anxiety. It is composed of two scales of items with semantic content which expresses the absence or presence of anxiety. Higher scores indicate higher levels of anxiety.

  • Change from baseline in VSRT at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The VSRT will be used to assess the flexibility mainly of the hamstring muscles and also of the lower back.

  • Change from baseline in VAS at 4 weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    In the VAS, the subject marks the intensity of its pain in a 10 centimeter horizontal line.

  • Change from baseline in ABC scale at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in ABC scale at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in PT mean at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    In dolorimetry, the PT of 18 tender points are measured with the dolorimeter. Then the PT mean will be calculated.

  • Change from baseline in PT mean at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    In dolorimetry, the PT of 18 tender points are measured with the dolorimeter. Then the PT mean will be calculated.


Enrollment: 34
Study Start Date: July 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shiatsu Group Other: Shiatsu
8-week treatment with two Shiatsu sessions per week (50-minute duration)
Other Name: Acupressure
No Intervention: Control Group

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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291043

Locations
Brazil
University of Sao Paulo General Hospital
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Susan LK Yuan, MSc Faculty of Medicine of the University of Sao Paulo
Study Director: Amelia P Marques, PhD Faculty of Medicine of the University of Sao Paulo
  More Information

No publications provided

Responsible Party: Susan Yuan, MD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01291043     History of Changes
Other Study ID Numbers: 1297/09
Study First Received: January 27, 2011
Last Updated: November 14, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Shiatsu
Fibromyalgia
Pain
Quality of sleep
Balance
Quality of life

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2014