FibromyalgiaNCT02257034
The Effect of Tai Chi in Treating Fibromyalgia
A study testing Taichi and Dance in people with Fibromyalgia, run by Chengdu PLA General Hospital at 1 site in China.
Trial summary
To evaluate the effect of Tai chi on Fibromyalgia Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Taichi and Dance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or older
- meeting the classification of FM per the 1990 ACR criteria
- approval by a healthcare provider for participation
Who cannot join
- had practiced Tai chi within the past 6 months
- had exercised >30 min three times weekly for past 3 months
- could not independently ambulate without assistive devices
- had BPI pain severity or interference scores less than 5
- had planned elective surgery during study period
- were actively involved in health-related litigation
- were unwilling to keep all treatments/medications steady throughout the study period
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Chengdu Military Area Command PLA
Chengdu, Sichuan, 610083
About this study
To evaluate the effect of Tai chi on Fibromyalgia
- Conditions
- Fibromyalgia
- Being tested
- Taichi, Dance
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaichiOther
DanceOther
| Study group | Role | What they receive |
|---|---|---|
| Taichi | Experimental | patients exercise with Tai chi Receives: Other: Taichi |
| Control | Sham comparator | patients under exercise of dance Receives: Other: Dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Min, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257034
- Sponsor's protocol ID
- TC20140601
- Status last verified
- Mar 2017
- First submitted
- 2 Oct 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tai Chi in Treating Fibromyalgia
- ClinicalTrials.gov ID
- NCT02257034
- Acronym / sponsor ID
- TC20140601
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chengdu PLA General HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Oct 2014 (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.
To evaluate the effect of Tai chi on Fibromyalgia
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taichi | Experimental | Other: Taichipatients exercise with Tai chi |
| Control | Sham comparator | Other: Dancepatients under exercise of dance |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years of age or older
- meeting the classification of FM per the 1990 ACR criteria
- approval by a healthcare provider for participation
Key exclusion criteria (7 listed)
- had practiced Tai chi within the past 6 months
- had exercised >30 min three times weekly for past 3 months
- could not independently ambulate without assistive devices
- had BPI pain severity or interference scores less than 5
- had planned elective surgery during study period
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 |
|---|---|---|
| Taichi | Other | Taichi |
| Dance | Other | Control |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taichi and Dance in people with Fibromyalgia, run by Chengdu PLA General Hospital at 1 site in China.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: up to 48 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 4 Apr 2017.