FibromyalgiaNCT01291043
Efficacy of Shiatsu in Individuals With Fibromyalgia: a Randomized Clinical Trial
A study testing Shiatsu in people with Fibromyalgia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Shiatsu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnoses of fibromyalgia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05403-010
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Shiatsu
- Keywords
- Shiatsu, Fibromyalgia, Pain, Quality of sleep, Balance, Quality of life
- Medical subject headings
- Fibromyalgia, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShiatsuOther
Also called Acupressure
8-week treatment with two Shiatsu sessions per week (50-minute duration)
| Study group | Role | What they receive |
|---|---|---|
| Shiatsu Group | Experimental | Not described Receives: Other: Shiatsu |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 8 weeks
Secondary outcomes (13)
Change from baseline in FIQ at 4 weeks
The FIQ is composed of ten items, in which higher scores indicate higher impact of fibromyalgia over quality of life
Measured: baseline and 4 weeks
Change from baseline in PSQI at 4 weeks
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.
Measured: baseline and 4 weeks
Change from baseline in STAI at 4 weeks
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.
Measured: baseline and 4 weeks
Change from baseline in VSRT at 4 weeks
The VSRT will be used to assess the flexibility mainly of the hamstring muscles and also of the lower back.
Measured: baseline and 4 weeks
Change from baseline in FIQ at 8 weeks
The FIQ is composed of ten items, in which higher scores indicate higher impact of fibromyalgia over quality of life.
Measured: baseline and 8 weeks
Change from baseline in PSQI at 8 weeks
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.
Measured: baseline and 8 weeks
Change from baseline in STAI at 8 weeks
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.
Measured: baseline and 8 weeks
Change from baseline in VSRT at 8 weeks
The VSRT will be used to assess the flexibility mainly of the hamstring muscles and also of the lower back.
Measured: baseline and 8 weeks
Change from baseline in VAS at 4 weeks
In the VAS, the subject marks the intensity of its pain in a 10 centimeter horizontal line.
Measured: Baseline and 4 weeks
Change from baseline in ABC scale at 4 weeks
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.
Measured: baseline and 4 weeks
Change from baseline in ABC scale at 8 weeks
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.
Measured: baseline and 8 weeks
Change from baseline in PT mean at 4 weeks
In dolorimetry, the PT of 18 tender points are measured with the dolorimeter. Then the PT mean will be calculated.
Measured: baseline and 4 weeks
Change from baseline in PT mean at 8 weeks
In dolorimetry, the PT of 18 tender points are measured with the dolorimeter. Then the PT mean will be calculated.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Yuan, University of Sao Paulo General Hospital
- Investigators
- Susan LK Yuan, MSc, Principal investigator, Faculty of Medicine of the University of Sao PauloAmelia P Marques, PhD, Study director, Faculty of Medicine of the University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291043
- Sponsor's protocol ID
- 1297/09
- Status last verified
- Nov 2012
- First submitted
- 27 Jan 2011
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Shiatsu in Pain, Flexibility, Sleep, Anxiety and Quality of Life in Individuals With Fibromyalgia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01291043
- Acronym / sponsor ID
- 1297/09
- Conditions
- Fibromyalgia
- Keywords
- Shiatsu, Fibromyalgia, Pain, Quality of sleep, Balance, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shiatsu Group | Experimental | Other: Shiatsu |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnoses of fibromyalgia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShiatsuAlso: Acupressure8-week treatment with two Shiatsu sessions per week (50-minute duration) | Other | Shiatsu Group |
Primary outcome
Change from baseline in VAS at 8 weeks
Time frame: baseline and 8 weeks
In the VAS the subject marks the intensity of its pain in a 10 centimeter horizontal line
13 secondary outcomes
Change from baseline in FIQ at 4 weeks
Time frame: baseline and 4 weeks
Change from baseline in PSQI at 4 weeks
Time frame: baseline and 4 weeks
Change from baseline in STAI at 4 weeks
Time frame: baseline and 4 weeks
Change from baseline in VSRT at 4 weeks
Time frame: baseline and 4 weeks
Change from baseline in FIQ at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in PSQI at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in STAI at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in VSRT at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in VAS at 4 weeks
Time frame: Baseline and 4 weeks
Change from baseline in ABC scale at 4 weeks
Time frame: baseline and 4 weeks
Change from baseline in ABC scale at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in PT mean at 4 weeks
Time frame: baseline and 4 weeks
Change from baseline in PT mean at 8 weeks
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan LK Yuan, MSc principal investigator
Faculty of Medicine of the University of Sao Paulo
Amelia P Marques, PhD study director
Faculty of Medicine of the University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shiatsu in people with Fibromyalgia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in VAS at 8 weeks (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2012.