(DC Area) Functional Magnetic Resonance Imaging as a Surrogate Measure of Fibromyalgia Symptoms
(Opened 2009--- )
Do you have Fibromyalgia? Do you ache all over?
Do your muscles twitch tingle or burn for no reason?
Do you have widespread muscle pain and fatigue that limit how much you can do in a day?
Do you have areas around your neck and shoulders that are tender to the touch?
Do you have muscle stiffness and pain that seems worse in the morning?
Do you have trouble falling asleep and staying asleep?
Have you missed activities with family or friends because you were too tired or in pain?
Millions of Americans, like you, experience real pain and real fatigue that affect every part of your life.
WHAT IS THE PURPOSE?
All of the above may be symptoms of Fibromyalgia. Volunteers are needed for a research study evaluating the Role of MRI and Physical Therapy in evaluation and management of Fibromyalgia.
We hope to use the fMRI techniques to be able to determine if a person has fibromyalgia, to determine if future therapies work, and to better understand the cause of the illness itself.
Inclusion Criteria:
Have a moderate-to-severe level of daily pain.
Be age 18-65, female
Not be taking any opioid analgesics or other strong painkillers.
Willing to come off medications for fibromyalgia
Willing to undergo MRI scans
Willingness to use contraception during the study duration
Other criteria apply
Exclusion Criteria:
- Severe concomitant psychiatric illness, suicide risk, or substance abuse as determined by the MINI or investigator judgment
- Significant claustrophobia that will interfere with fMRI or PET scanning
- Self-reported inability to adhere to the study exercise protocol
- Severe medical health problems that will interfere with successful participation.
- Systemic autoimmune disease, such as systemic lupus erythematosus and rheumatoid arthritis. Stable organ specific autoimmune disease, such as Graves disease and myasthenia gravis will be allowed.
- Active malignancy. Basal cell carcinoma will be allowed.
- Pregnant or breastfeeding.
If you qualify for this study, you will receive all study-related examinations, lab work and physical therapy at no cost and may receive compensation for your time and travel.
You may stop being in this study at any time without any penalty or losing any benefits you would have normally received. You may or may not benefit from taking part in the study, but knowledge may be gained from your participation that may help others.
For more information please call
Brian Walitt, MD, Rhematologist
MedStar Research Institute
(202) 877-8535
docwalitt@hotmail.com
Study Flyer 1
http://cfsnova.com/trials/WalittFlyer1Oct09fMRI.PDF
Study Flyer 2
http://cfsnova.com/trials/WalittFlyer2Oct09fMRI.PDF
Study Approval Notice and Informed Consent Notice
http://cfsnova.com/trials/WalittApprovalfMRI.PDF
(Includes a section of who would be eliminated from participating, many more details.)
PDF copy of Letter from Dr. Walitt to CFSupport
http://cfsnova.com/trials/WalittLetter.PDF
(Opened 2009--- )
Do you have Fibromyalgia? Do you ache all over?
Do your muscles twitch tingle or burn for no reason?
Do you have widespread muscle pain and fatigue that limit how much you can do in a day?
Do you have areas around your neck and shoulders that are tender to the touch?
Do you have muscle stiffness and pain that seems worse in the morning?
Do you have trouble falling asleep and staying asleep?
Have you missed activities with family or friends because you were too tired or in pain?
Millions of Americans, like you, experience real pain and real fatigue that affect every part of your life.
WHAT IS THE PURPOSE?
All of the above may be symptoms of Fibromyalgia. Volunteers are needed for a research study evaluating the Role of MRI and Physical Therapy in evaluation and management of Fibromyalgia.
We hope to use the fMRI techniques to be able to determine if a person has fibromyalgia, to determine if future therapies work, and to better understand the cause of the illness itself.
Inclusion Criteria:
Have a moderate-to-severe level of daily pain.
Be age 18-65, female
Not be taking any opioid analgesics or other strong painkillers.
Willing to come off medications for fibromyalgia
Willing to undergo MRI scans
Willingness to use contraception during the study duration
Other criteria apply
Exclusion Criteria:
- Severe concomitant psychiatric illness, suicide risk, or substance abuse as determined by the MINI or investigator judgment
- Significant claustrophobia that will interfere with fMRI or PET scanning
- Self-reported inability to adhere to the study exercise protocol
- Severe medical health problems that will interfere with successful participation.
- Systemic autoimmune disease, such as systemic lupus erythematosus and rheumatoid arthritis. Stable organ specific autoimmune disease, such as Graves disease and myasthenia gravis will be allowed.
- Active malignancy. Basal cell carcinoma will be allowed.
- Pregnant or breastfeeding.
If you qualify for this study, you will receive all study-related examinations, lab work and physical therapy at no cost and may receive compensation for your time and travel.
You may stop being in this study at any time without any penalty or losing any benefits you would have normally received. You may or may not benefit from taking part in the study, but knowledge may be gained from your participation that may help others.
For more information please call
Brian Walitt, MD, Rhematologist
MedStar Research Institute
(202) 877-8535
docwalitt@hotmail.com
Study Flyer 1
http://cfsnova.com/trials/WalittFlyer1Oct09fMRI.PDF
Study Flyer 2
http://cfsnova.com/trials/WalittFlyer2Oct09fMRI.PDF
Study Approval Notice and Informed Consent Notice
http://cfsnova.com/trials/WalittApprovalfMRI.PDF
(Includes a section of who would be eliminated from participating, many more details.)
PDF copy of Letter from Dr. Walitt to CFSupport
http://cfsnova.com/trials/WalittLetter.PDF