FibromyalgiaBiomarkersNCT00932061
Developing Biomarkers for Fibromyalgia
A study testing Traditional Acupuncture in people with Fibromyalgia, run by University of Michigan at 1 site in United States.
Trial summary
The hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a series of acupuncture or "sham" acupuncture (something that resembles, but is not, active acupuncture) sessions. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Traditional Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2010
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia for at least 1 year
- Chronic pain more than 50% of days
- Willing to limit introduction of any new medications or treatments for fibromyalgia during the study
- Able to attend study visits up to three times weekly
- Right-handed
- Be capable of giving written informed consent
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- Willing to refrain from alcohol intake for 48 hours prior to brain scans
- Be right handed
- Be capable of giving written informed consent
- PET Inclusion Criteria:
- Willing to refrain from alcohol intake 48 hours prior to brain scans
- Capable of giving written consent
Who cannot join
- Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)
- Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture
- Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
- Daily use of narcotic pain-relievers
- History of substance abuse
- Simultaneous participation in other therapeutic trials
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- Pregnant or breastfeeding
- Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
- Condition that may make exposure to fMRI medically inadvisable
- Any condition that may prevent satisfactory completion of the study protocol
- Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
- Having met the ACR criteria for FM
- Simultaneous participation in other therapeutic trials
- Pregnant or breastfeeding
- Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
- Condition that may make exposure to fMRI medically inadvisable
- Any condition that may prevent satisfactory completion of the study protocol
- PET Exclusion Criteria:
- Meets any of the fMRI exclusion criteria
- Current major depression
- Condition that may make exposure to PET medically inadvisable
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, 48106
About this study
The hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a series of acupuncture or "sham" acupuncture (something that resembles, but is not, active acupuncture) sessions. If the subject qualifies for the investigators' research and are subsequently enrolled in this study, they will be randomly assigned (like the flip of a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to improvements in both clinical and evoked pain associated with fibromyalgia. The study involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at the end of the study. Another optional portion of the study would involve 2 PET (positron emission tomography) scans of the subject's brain, one at the beginning and one at the end of the study; this type of scan allows us to get more specific information about the subject's brain function during an acupuncture session.
- Conditions
- Fibromyalgia
- Being tested
- Traditional Acupuncture, Sham Treatment
- Keywords
- Fibromyalgia, Healthy controls, Acupuncture, Sham Acupuncture, fMRI, Biological marker
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional AcupunctureOther
Fibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks.
Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.
Sham TreatmentOther
Fibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks.
Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Acupuncture | Active comparator | Acupuncture sites will be used for active intervention. Receives: Other: Traditional Acupuncture |
| Sham Treatment | Sham comparator | Sham acupuncture is used. Receives: Other: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI signal
Measured: pre treatment - week 1
PET signal
Measured: pre treatment - week 1
H-MRS Glutamate
Measured: pre treatment - week 1
fMRI signal
Measured: post treatment - week 5
PET signal
Measured: post treatment - week 5
H-MRS - Glutamate
Measured: post treatment - week 5
Secondary outcomes (2)
Pain
Measured: pre treatment - week 1
Pain
Measured: post treatment - week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The Dana Foundation, United States Department of Defense
- Responsible party
- Principal investigator, Richard Harris, University of Michigan
- Investigators
- Richard Harris, Ph.D., Principal investigator, Univeristy of Michigan, Chronic Pain & Fatigue Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932061
- Sponsor's protocol ID
- Hum 00010061
- Other IDs
- F017513, Sponsor(DOD) W81XWH-07-20050
- Acronym
- Biomarkers
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2009
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6.
PubMed 19501658Harris RE, Sundgren PC, Pang Y, Hsu M, Petrou M, Kim SH, McLean SA, Gracely RH, Clauw DJ. Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia. Arthritis Rheum. 2008 Mar;58(3):903-7. doi: 10.1002/art.23223.
PubMed 18311814Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007.
PubMed 17855614Harris RE, Sundgren PC, Craig AD, Kirshenbaum E, Sen A, Napadow V, Clauw DJ. Elevated insular glutamate in fibromyalgia is associated with experimental pain. Arthritis Rheum. 2009 Oct;60(10):3146-52. doi: 10.1002/art.24849.
PubMed 19790053Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.
PubMed 20506181
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Biomarkers for Fibromyalgia
- ClinicalTrials.gov ID
- NCT00932061
- Acronym / sponsor ID
- Biomarkers / Hum 00010061
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Healthy controls, Acupuncture, Sham Acupuncture, fMRI, Biological marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The Dana Foundation, United States Department of Defense
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Jul 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 hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a series of acupuncture or "sham" acupuncture (something that resembles, but is not, active acupuncture) sessions. If the subject qualifies for the investigators' research and are subsequently enrolled in this study, they will be randomly assigned (like the flip of a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to improvements in both clinical and evoked pain associated with fibromyalgia. The study involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at the end of the study. Another optional portion of the study would involve 2 PET (positron emission tomography) scans of the subject's brain, one at the beginning and one at the end of the study; this type of scan allows us to get more specific information about the subject's brain function during an acupuncture session.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Acupuncture | Active comparator | Other: Traditional AcupunctureAcupuncture sites will be used for active intervention. |
| Sham Treatment | Sham comparator | Other: Sham TreatmentSham acupuncture is used. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Has met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia for at least 1 year
- Chronic pain more than 50% of days
- Willing to limit introduction of any new medications or treatments for fibromyalgia during the study
- Able to attend study visits up to three times weekly
- Right-handed
Key exclusion criteria (21 listed)
- Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)
- Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture
- Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
- Daily use of narcotic pain-relievers
- History of substance abuse
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 |
|---|---|---|
| Traditional AcupunctureFibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks. Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria. | Other | Traditional Acupuncture |
| Sham TreatmentFibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks. Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria. | Other | Sham Treatment |
Primary outcome
fMRI signal
Time frame: pre treatment - week 1
PET signal
Time frame: pre treatment - week 1
H-MRS Glutamate
Time frame: pre treatment - week 1
fMRI signal
Time frame: post treatment - week 5
PET signal
Time frame: post treatment - week 5
H-MRS - Glutamate
Time frame: post treatment - week 5
2 secondary outcomes
Pain
Time frame: pre treatment - week 1
Pain
Time frame: post treatment - week 5
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 30 Jul 2020.
- Results publication: PubMed 19501658Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6.
- Results publication: PubMed 18311814Harris RE, Sundgren PC, Pang Y, Hsu M, Petrou M, Kim SH, McLean SA, Gracely RH, Clauw DJ. Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia. Arthritis Rheum. 2008 Mar;58(3):903-7. doi: 10.1002/art.23223.
- Results publication: PubMed 17855614Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007.
- Results publication: PubMed 19790053Harris RE, Sundgren PC, Craig AD, Kirshenbaum E, Sen A, Napadow V, Clauw DJ. Elevated insular glutamate in fibromyalgia is associated with experimental pain. Arthritis Rheum. 2009 Oct;60(10):3146-52. doi: 10.1002/art.24849.
- Results publication: PubMed 20506181Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.
- Chronic Pain and Fatigue Research CenterLink 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.
Richard Harris, Ph.D. principal investigator
Univeristy of Michigan, Chronic Pain & Fatigue Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Acupuncture in people with Fibromyalgia, run by University of Michigan at 1 site in United States.
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 12 inclusion and 21 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 30 Jul 2020. 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 United States. 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?
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?
fMRI signal (time frame: pre treatment - week 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932061, which also lists 5 linked publications.
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 30 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.