FibromyalgiaNCT00882271
Fibromyalgia Acupuncture Study
A study testing Acupuncture in people with Fibromyalgia, run by Southern California University of Health Sciences.
Trial summary
The acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with Fibromyalgia, while improving the quality of life and promoting general health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 18 years or older and can be of either sex.
- A confirmed diagnosis of FM (pain for more than three months) will be required to participate in the study. If they do not have a diagnosis the study clinician or research assistant will examine them and determine their eligibility.
- All participants must be willing to provide a written informed consent prior to participation and should not have undergone acupuncture treatment in the past.
Who cannot join
- Acupuncture treatment in the past five years.
- Unwilling to sign informed consent.
- Less than a score of 40 on the Fibromyalgia Impact Questionnaire,
- Involvement in any litigation currently or in the past,
- Simultaneous infection with HIV/Hepatitis B virus.
- Severe depression (Beck depression score >21),
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- History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical conditions (including unstable hypertension, hypo or hyperthyroidism, or psychological conditions that in the opinion of the investigators would compromise participation or be likely to lead to an adverse response, including injuries or hospitalization, during the course of the study. We will get the information from the health/activity questionnaire.
- Have any DSM-IV Axis (major depression, addiction, anxiety) disorder which, in the judgment of the investigators, would interfere with compliance with the study protocol.
About this study
Official title: Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia
The acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with Fibromyalgia, while improving the quality of life and promoting general health.
Read the detailed description
It is hypothesized that acupuncture treatment will be effective in reducing pain and improving lower body strength and overall functionality more than the sham acupuncture treatment in people with Fibromyalgia (FM). The purpose of this study is to compare the efficacy of acupuncture with simulated acupuncture in patients with FM using a randomized controlled design. More specifically, the objectives of this study are to determine if acupuncture can (1) reduce pain, (2) improve lower body strength, and (3) improve overall functionality.
- Conditions
- Fibromyalgia
- Being tested
- Acupuncture
- Keywords
- Fibromyalgia, Acupuncture, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Ten Acupuncture treatments within six weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Traditional Chinese Acupuncture Receives: Other: Acupuncture |
| 2 | Placebo comparator | Placebo Acupuncture Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health/Activity Questionnaire
Measured: Baseline
The Fibromyalgia Impact Questionnaire
Measured: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Multidimensional Pain Inventory
Measured: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Beck Depression Inventory
Measured: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Secondary outcomes (1)
30-sec Chair Stand
Measured: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startJan 2008
- 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sivarama Vinjamury, Southern California University of Health Sciences
- Investigators
- Sivarama P Vinjamury, MD, MAOM, Principal investigator, Southern California University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882271
- Sponsor's protocol ID
- SCU-08-VINJ003
- Status last verified
- Nov 2011
- First submitted
- 14 Apr 2009
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00882271
- Acronym / sponsor ID
- SCU-08-VINJ003
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Acupuncture, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Southern California University of Health SciencesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Apr 2009 (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.
The acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with Fibromyalgia, while improving the quality of life and promoting general health.
Detailed description
It is hypothesized that acupuncture treatment will be effective in reducing pain and improving lower body strength and overall functionality more than the sham acupuncture treatment in people with Fibromyalgia (FM). The purpose of this study is to compare the efficacy of acupuncture with simulated acupuncture in patients with FM using a randomized controlled design. More specifically, the objectives of this study are to determine if acupuncture can (1) reduce pain, (2) improve lower body strength, and (3) improve overall functionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: AcupunctureTraditional Chinese Acupuncture |
| 2 | Placebo comparator | Other: AcupuncturePlacebo Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be 18 years or older and can be of either sex.
- A confirmed diagnosis of FM (pain for more than three months) will be required to participate in the study. If they do not have a diagnosis the study clinician or research assistant will examine them and determine their eligibility.
- All participants must be willing to provide a written informed consent prior to participation and should not have undergone acupuncture treatment in the past.
Key exclusion criteria (9 listed)
- Acupuncture treatment in the past five years.
- Unwilling to sign informed consent.
- Less than a score of 40 on the Fibromyalgia Impact Questionnaire,
- Involvement in any litigation currently or in the past,
- Simultaneous infection with HIV/Hepatitis B virus.
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 |
|---|---|---|
| AcupunctureTen Acupuncture treatments within six weeks | Other | 1, 2 |
Primary outcome
Health/Activity Questionnaire
Time frame: Baseline
The Fibromyalgia Impact Questionnaire
Time frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Multidimensional Pain Inventory
Time frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Beck Depression Inventory
Time frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
1 secondary outcome
30-sec Chair Stand
Time frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
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 18 Nov 2011.
- Visit Southern California University of Health Sciences WebsiteLink provided by the sponsor.
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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.
Sivarama P Vinjamury, MD, MAOM principal investigator
Southern California University of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Fibromyalgia, run by Southern California University of Health Sciences.
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 9 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 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Health/Activity Questionnaire (time frame: Baseline). The study lists 4 primary outcomes in all. 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 18 Nov 2011.