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

NCT01291043 | Completed

• 1 other identifier: 1297/09
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Shiatsu; Fibromyalgia; Pain; Quality of sleep; Balance; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change from baseline in VAS at 8 weeks

  In the VAS the subject marks the intensity of its pain in a 10 centimeter horizontal line

  baseline and 8 weeks

Secondary Outcomes (13)

• Change from baseline in FIQ at 4 weeks

  baseline and 4 weeks

• Change from baseline in PSQI at 4 weeks

  baseline and 4 weeks

• Change from baseline in STAI at 4 weeks

  baseline and 4 weeks

• Change from baseline in VSRT at 4 weeks

  baseline and 4 weeks

• Change from baseline in FIQ at 8 weeks

  baseline and 8 weeks

Study Arms (2)

Shiatsu Group

EXPERIMENTAL

Other: Shiatsu

Control Group

NO INTERVENTION

Interventions

Shiatsu OTHER

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

Also known as: Acupressure

Shiatsu Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnoses of fibromyalgia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia; Pain; Sleep Initiation and Maintenance Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Susan LK Yuan, MSc

  Faculty of Medicine of the University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Amelia P Marques, PhD

  Faculty of Medicine of the University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 7, 2011
• Study Start: July 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 15, 2012

Record last verified: 2012-11

Locations

BR (1)