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

January 27, 2011
November 14, 2012
July 2010
November 2011   (final data collection date for primary outcome measure)
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
Change from baseline in pain at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Pain will be evaluated by the following instruments: visual analogue scale, in which the subject marks the intensity of its pain in a 10 cm horizontal line; pain map, in which the subject marks its painful areas; and dolorimetry, in which the pain thresholds of 18 tender points are measured with the dolorimeter.
Complete list of historical versions of study NCT01291043 on ClinicalTrials.gov Archive Site
  • 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.
  • Change from baseline in quality of life at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The evaluation of quality of life will be made with two instruments: fibromyalgia impact questionnaire, composed of ten items, in which higher scores indicate higher impact of fibromyalgia over quality of life; and Activities-specific Balance Confidence scale, that 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 quality of sleep at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The sleep will be evaluated with the Pittsburgh Sleep Quality Index, which is constituted of 19 questions. Scores of five or more indicate bad sleep quality and sleep disturbances.
  • Change from baseline in anxiety at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The State-Trait Anxiety Inventory 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 obtained in each scale indicate higher levels of anxiety.
  • Change from baseline in flexibility at 4 weeks [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The V-sit and reach test will be used to assess the flexibility mainly of the hamstring muscles and also of the lower back.
  • Change from baseline in quality of life at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The evaluation of quality of life will be made with two instruments: fibromyalgia impact questionnaire, composed of ten items, in which higher scores indicate higher impact of fibromyalgia over quality of life; and Activities-specific Balance Confidence scale, that 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 quality of sleep at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The sleep will be evaluated with the Pittsburgh Sleep Quality Index, which is constituted of 19 questions. Scores of five or more indicate bad sleep quality and sleep disturbances.
  • Change from baseline in anxiety at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The State-Trait Anxiety Inventory 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 obtained in each scale indicate higher levels of anxiety.
  • Change from baseline in flexibility at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    The V-sit and reach test will be used to assess the flexibility mainly of the hamstring muscles and also of the lower back.
  • Change from baseline in pain at 4 weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    Pain will be evaluated by the following instruments: visual analogue scale, in which the subject marks the intensity of its pain in a 10 cm horizontal line; pain map, in which the subject marks its painful areas; and dolorimetry, in which the pain thresholds of 18 tender points are measured with the dolorimeter.
Not Provided
Not Provided
 
Efficacy of Shiatsu in Individuals With Fibromyalgia: a Randomized Clinical Trial
Efficacy of Shiatsu in Pain, Flexibility, Sleep, Anxiety and Quality of Life in Individuals With Fibromyalgia: a Randomized Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
Other: Shiatsu
8-week treatment with two Shiatsu sessions per week (50-minute duration)
Other Name: Acupressure
  • Experimental: Shiatsu Group
    Intervention: Other: Shiatsu
  • No Intervention: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01291043
1297/09
No
Susan Yuan, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
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
University of Sao Paulo General Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP