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Developing Biomarkers for Fibromyalgia (Biomarkers)

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Traditional Acupuncture

Sham Treatment

About this trial

This is an interventional diagnostic trial for Fibromyalgia focused on measuring Fibromyalgia, Healthy controls, Acupuncture, Sham Acupuncture, fMRI, Biological marker

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion Criteria for Fibromyalgia Volunteers:

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

Inclusion Criteria for Healthy Volunteers:

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

Exclusion Criteria:

Exclusion Criteria for Fibromyalgia Volunteers:

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
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

Exclusion for Healthy Volunteers:

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

Sites / Locations

University of Michigan, Chronic Pain and Fatigue Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Traditional Acupuncture

Sham Treatment

Arm Description

Acupuncture sites will be used for active intervention.

Sham acupuncture is used.

Outcomes

Primary Outcome Measures

fMRI signal

PET signal

H-MRS Glutamate

fMRI signal

PET signal

H-MRS - Glutamate

Secondary Outcome Measures

Pain

Full Information

NCT ID

NCT00932061

First Posted

June 25, 2009

Last Updated

July 29, 2020

Sponsor

University of Michigan

Collaborators

The Dana Foundation, United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT00932061

Brief Title

Developing Biomarkers for Fibromyalgia

Acronym

Biomarkers

Official Title

Developing Biomarkers for Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

The Dana Foundation, United States Department of Defense

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Healthy controls, Acupuncture, Sham Acupuncture, fMRI, Biological marker

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Traditional Acupuncture

Arm Type

Active Comparator

Arm Description

Acupuncture sites will be used for active intervention.

Arm Title

Sham Treatment

Arm Type

Sham Comparator

Arm Description

Sham acupuncture is used.

Intervention Type

Other

Intervention Name(s)

Traditional Acupuncture

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sham Treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

fMRI signal

Time Frame

pre treatment - week 1

Title

PET signal

Time Frame

pre treatment - week 1

Title

H-MRS Glutamate

Time Frame

pre treatment - week 1

Title

fMRI signal

Time Frame

post treatment - week 5

Title

PET signal

Time Frame

post treatment - week 5

Title

H-MRS - Glutamate

Time Frame

post treatment - week 5

Secondary Outcome Measure Information:

Title

Pain

Time Frame

pre treatment - week 1

Title

Pain

Time Frame

post treatment - week 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria for Fibromyalgia Volunteers: 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 Inclusion Criteria for Healthy Volunteers: 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 Exclusion Criteria: Exclusion Criteria for Fibromyalgia Volunteers: 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 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 Exclusion for Healthy Volunteers: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Harris, Ph.D.

Organizational Affiliation

Univeristy of Michigan, Chronic Pain & Fatigue Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan, Chronic Pain and Fatigue Research Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19501658

Citation

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.

Results Reference

result

PubMed Identifier

18311814

Citation

Harris 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 Reference

result

PubMed Identifier

17855614

Citation

Harris 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 Reference

result

PubMed Identifier

19790053

Citation

Harris 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 Reference

result

PubMed Identifier

20506181

Citation

Napadow 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.

Results Reference

result

Links:

URL

http://www.med.umich.edu/painresearch/study/index.htm

Description

Chronic Pain and Fatigue Research Center

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Developing Biomarkers for Fibromyalgia

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