This is our page on clinical trials for chronic fatigue syndrome,
fibromyalgia, multiple chemical sensitivities, Gulf War illness, and
related disorders. Studies can center around a treatment
for improving overall functioning or a specific symptom, attitudes
about illness by sufferers or towards them, coping mechanisms, general
data gathering and research, or other things. The first section deals with factors to consider in
deciding whether a clinical trial is right for you. The next section
contains links for US national listings of trials and studies, including
several specific to these disorders.
Finally,
a special section has selected current clinical trials
in our home region of
Washington DC, Northern Virginia, and Suburban Maryland, as well as
other selected national and international clinical trials. We
especially like to include those that can be done by mail or web
questionnaire since more accessible (no travel, expense). Inclusion of
a clinical trial in our
listings is for informational purposes only and should not be read as a
recommendation that you should participate in that trial or that we
agree with a study's premise. In
considering whether a particular clinical trial is right for you,
please talk with the contact person for that trial, consult with your
health care provider, and be sure to read the materials listed under
the "Factors to Consider" section of this page.
Factors
to Consider In Deciding Whether to Participate in a Clinical Trial
Links to US National
Listings of Clinical Trials
Selected
Current Clinical Trials
- Washington, DC Metro Region aka The US Capital, Northern VA, & some Maryland
- USA beyond the Capital Area - National - Includes Questionnaire Studies
- International - Includes Questionnaire or Survey Studies
Selected Capital Area CFS/ ME & FMS & OI Studies
Let us know if you have information about a current
clinical trial relating to CFS, FMS, or overlapping disorders in the
Washington DC, VA, MD metropolitan area.
1 (DC Area) James Baraniuk, MD, at Georgetown receives NIH funding for CFS Research
2 (DC Area) Mary Lee Esty, LCSW-C, PhD - Flexyx Neurotherapy, Bethesda, MD
3 (DC Area) Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With FM
4 (DC Area) Functional Magnetic Resonance Imaging as a Surrogate Measure of Fibromyalgia Symptoms
5) (DCArea) Joint Hypermobility Syndrome and FMS - Our May 2010 Meeting, by appt
1) (DC Area) Dr. Baraniuk at Georgetown receives NIH funding for CFS Research
October 2006, Receiving NIH Funding:
James Baraniuk, M.D., Georgetown University, Washington D.C., has found
that despite its diverse clinical syndromes, the CFS proteome (the
entire group of proteins in an organism or system) is the same,
suggesting a strong relationship with malfunctioning of the central
nervous system. Dr. Baraniuk developed the first predictive model of
CFS based solely on objective data and he now proposes to recruit a new
group of CFS and Healthy Control subjects to determine if the proteins
in their cerebrospinal fluid will be a predictive marker of the
spectrum of CFS symptoms. There is a high probability that these
methods and markers will be of diagnostic value and will be useful for
assessing changes over time in disease severity and treatment effects.
Study ad, added 9/6/07. Dr Baraniuk visited group 9/15/07. Still recruiting 3/2008....
Do you or someone you love have Chronic Fatigue Syndrome (CFS)?
We
have performed lumbar punctures (“spinal taps”) on CFS,
fibromyalgia (FM), and Persian Gulf War Illness (PGI) subjects and a
group of healthy volunteers. The CFS and related groups had a unique
set of proteins in the fluid surrounding their brains. This is very
exciting because it is strong evidence that CFS, FM and PGI are
“real” diseases. The proteins we found may turn out to be
diagnostic markers for these syndromes, and become part of a test for
CFS/FM/PGI illnesses. They also offer insights into the molecular
mechanisms that go awry, and point towards potential treatments. First,
however, we must perform more spinal taps on women with CFS and healthy
control women.
We offer a new, paid, clinical research
study with a 1 night stay at Georgetown University Medical Center,
lumbar puncture and other, more simple tests. We are recruiting 50
women with CFS and 50 healthy women who want to help find a cure.
Contact us at 202-687-8231 or by e-mail at cfsresearch@georgetown.edu .
Healthy
women are also invited to participate by having lumbar punctures.
Healthy volunteers are essential to be able to identify new,
significant diagnostic markers that can distinguish between chronic
fatigue syndrome and a normal state of health. These differences will
point towards the cause(s) of chronic fatigue syndrome and potential
new ideas about treatment and diagnosis.
All lumbar
punctures will be performed in the Interventional Neuroradiology suite
by skilled doctors and their staff. This special step is being taken to
make sure that the procedure is performed in the safest possible
fashion, and with the lowest possible number headaches or other
complications.
2) (DC Area) Flexyx Neurotherapy & Surface Electromyography Treatments for FM
Principal Investigators: Mary Lee Esty, LCSW-C, PhD and Emily Perlman, MS, BCIA
Sponsor: Neurotherapy Center of Washington
7920 Norfolk Ave. #200
Bethesda, MD 20814
(301) 652-7175
PURPOSE: Participants are invited to join in this
research study because they have fibromyalgia. The purpose of this
study is to determine whether a relatively new treatment method called
the Flexyx Neurotherapy System (FNS) is effective for reducing
fibromyalgia symptoms. About 15 persons will take part in this study at
the Neurotherapy Center of Washington. If you agree to join and do not
withdraw later, you will be in this study for about 10 to 11 months
depending upon your group assignment.
PROCEDURES: First, you
will have a brief interview to see if you meet the initial criteria for
being included in the study. This will take about one hour and will
include a history of your medical condition and some questions about
your emotional status. Your physician will be asked to confirm the
diagnosis of fibromyalgia as part of acceptance into the study. If you
meet the criteria, then an evaluation of your brainwave
(electroencephalogram or EEG) functioning (also called
“mapping”) will be conducted. In addition, an evaluation of
certain muscle activity patterns (by means of procedures called surface
electromyography or sEMG) will be conducted. You must consult your
physician before, however, because you are asked to be off of
medications for pain, depression, and/or anxiety for 48 hours prior to
the evaluations. You and your physician can decide if that is possible,
and we can discuss your particular situation with you. These evaluation
sessions will take about 2½ hours.
After meeting EEG
mapping criteria and the sEMG evaluation criteria for acceptance into
the study, you will be asked to complete some research questionnaires
about your symptoms, including pain, cognitive issues (e.g., attention,
concentration, memory problems), fatigue, mood, and sleep, and activity
patterns. You will be asked to complete the research questionnaires
every five sessions and at the 3- and 6-month follow-up sessions. These
will take, at most, one hour.
On a random basis (like the flip
of a coin), you will be assigned to one of three study groups. One
group will undergo the FNS therapy only. The other two groups will
receive eight sEMG treatments either before or after receiving FNS
treatments. All groups will receive 28 treatment sessions regardless of
assignment. FNS sessions will occur about 1-2 times per week and sEMG
sessions will occur only one time per week.
Over a period of
10 to 11 months, your time commitment will involve the following. In
addition to the screening procedures described above, there will be 28
one-half hour weekly or bi-weekly treatment sessions over a period of
approximately 3½ to 4½ months, depending upon your group
assignment. Immediately at the conclusion of the treatment sessions and
again at 3- and 6-month follow-up, there will be a repeat of the EEG
mapping and sEMG evaluations, and you will be asked to again complete
the same questionnaires (an additional one hour maximum).
For more information on this, call 301-652-7175 and ask to speak to a therapist.
3) Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia
(Opened 9/29/06 -- still recruiting 08/09)
http://www.clinicaltrials.gov/ct2/show/NCT00383084
Johns Hopkins University
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
Meets American College of Rheumatology (ACR) criteria for FM
Inactive at study entry
Willing to become more physically active
Understands and willing to follow study recommendations regarding lifestyle modification
Able to participate in the study for 2 years
Agrees to not make any changes to current FM-related treatments
Contact: Kevin Fontaine, PhD 410-550-2517 kfontai1@jhmi.edu
4) (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
5) (DCArea) Joint Hypermobility Syndrome and FMS - Our May 2010 Meeting, by appt
Research meeting on FMS & Joint Hypermobility - added May 3, 2010 NOVA CFSupport Meeting Sully Governmental Center, James McDonnell Room (same building as Sully District Police Station) 4900 Stonecroft Blvd, Chantilly VA 20151. Free. No registration required. (703) 968-9818, (410) 647-7578. See also: Meetings, SPECIAL Directions as GPS & Internet Maps incorrect. Catie
D. is a junior at a college in VA. She is majoring in Exercise and
Health Sciences and doing research over the summer of 2010 for her
degree. Her research project will look at those with varying
degrees of fibromyalgia (FMS) and testing them for joint hypermobility
syndrome (JHS) to see if there is any correlation between FMS and
JHS. She and licensed physical therapist, Secili
DeStefano, will be administering questionnaires (includes medical
history, the Fibromyalgia Impact Questionnaire (FIQ), and a Symptoms
Intensity (SI)) to measure pain levels and functionality. They will
also administer the Beighton/Brighton Score that will measure the
amount of hypermobility in each participant. The Beighton score
is administered by asking the patient to perform simple movements (ex.
extending their arm to show if there is any hyperextension). Participants between ages 20 and 60 who are believed to have FMS who have signs/symptoms of FMS are needed. In
addition to a consent form for general participation, permission must
also be given for PHOTOGRAPHS to be taken, though no photographs of
faces will be included. Excluded from participation are those
who have had wrist surgery/carpals tunnel syndrome, pregnant/postpartum
women, and those with lower back surgery/fusion of the vertebrae in the
lumbar region. Please contact the researchers for further information: Catie DSecili DeStefano, PT, DPT, OCS 703-406-0296 Northern District Chair Virginia Physical Therapy Association and 45945 Center Oak Plz Suite 150 Sterling, VA 20166
Selected National CFS/ME, FMS, POTS/OI, & similar Trials
Section Contents, click for details.
1) Pregnancy in Fibromyalgia Questionnaire Study
Temple University in Philadelphia, PA. Long distance participants welcome.
2) CFS/ME in Children - Questionnaire
DePaul University, IL. Long distance participants welcome.
3) Psychosocial Treatment Trial for Multi-Symptom Illness, FM, CFS, IBS, TMJ, MCS
Robert Wood Johnson Medical School, central NJ.
4) Insomnia Medication Trial or FM Patients
Robert Wood Johnson Medical School, central NJ.
5) Study of Ampligen in Chronic Fatigue Syndrome: Recruiting Once Again
Incline Village, NV; Salt Lake City, UT; Charlotte, NC.
6) A Study of Genetic Risk Factors That May Be Associated
with Chronic Fatigue Syndrome (CFS)
University of Illinois at Chicago and Tufts University Added May 23, '08
Long distance participants welcome.
7) Chronic Fatigue Study Questionnaire Study
University of Utah
Added Oct 2, '08
Long distance participants welcome.
8) Vulvodynia - Cost of Illness Survey
National Vulvodynia Association
Added Oct 2, '08
Long distance participants welcome.
9) Fibromyalgia with Sleep Disturbances - medication trial
Raleigh, NC
Added Aug 20, '09
10) Fibromyalgia, Juvenile - Clinical Trial Testing the Safety and Efficacy of Fluoxetine
Cincinnati, OH
Added Aug 20, '09
Long distance participants welcome.
11) Coping Skills Training for Adolescents With Fibromyalgia
Kentucky and OH
Added Aug 20, '09
Long distance participants welcome.
12) Autonomic Nervous System and Chronic Fatigue Syndrome (CFS&ANS) (POTS)
Vanderbilt University, Nashville, TN
Added Aug 20, '09
13) Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
University of Virginia, Charlottesville, VA
Added Nov '09
1) The College of Health Professions at Temple University in Philadelphia
Pregnancy in Fibromyalgia Questionnaire Study; Participants accepted ~ mid 2007
Women in the 6th or 7th month of pregnancy between the ages of 21
and 45 may be eligible for a research study to compare functional
status in pregnant women with Fibromyalgia and pregnant women without
Fibromyalgia. Benefits include a better understanding of how
Fibromyalgia affects pregnancy. The study involves only the completion
of two questionnaires so can be done from home. Participants will
receive a gift
certificate to Walmart.
Dr. Karen Moore Schaefer, RN, at (215) 707-4626 or karen.schaefer@temple.edu
2) The Center for Community Research at DePaul University:
ME/CFS in children and adolescents.
In order to determine a diagnosis
of Pediatric ME/CFS, the child must report fatigue as well as classic
ME/CFS symptoms in each of the following categories for a duration of
at least 3 months in addition to a frequency and severity rating:
Classic ME/CFS Symptom Category
a. fatigue
b. Post-exertional malaise
c. Sleep
d. Pain - At least one symptom from: Myofascial, Joint, Abdominal, or Head pain
e. Neurocognition - At least two symptoms
f. Other Category - At least one symptom from two of the following three categories:
Autonomic manifestations:
Neuroendocrine manifestations:
Immune manifestations:
We are looking for children and adolescents ages 5-17 and their
parents/guardians to complete the DePaul Pediatric Health Questionnaire
(DPHQ).
* The DPHQ is a short questionnaire and will take about 30 minutes to complete
* Participation and answers will be kept confidential
* You can either mail the questionnaire back to us or we can pick it up.
Your time and voluntary assistance are needed and appreciated.
If you and your child are interesting in volunteering, please contact:
Lindsay Till
Email: ltill@depaul.edu
Telephone: (773) 325-1897
Research Team's website: http://condor.depaul.edu/~ljason/cfs/Principal Investigator: Leonard Jason, PhD
Enrollment will take place at least until the end of 2006.
Advertised with permission from DePaul IRB.
A significant problem in ME/CFS Research is the lack of both a
pediatric definition of ME/CFS and a reliable instrument to assess it.
The DPHQ was developed as a response to these problems. It is
hoped that findings from this study will help to develop an accurate
case definition of ME/CFS in young people and that the DPHQ will become
an instrumental tool for correctly identifying cases of Pediatric
ME/CFS.
3) Psychosocial Treatment Trial for Multi-Symptom Illness, FM, CFS, IBS, TMJ, MCS
Robert Wood Johnson Medical School, central NJ.
Study subjects must live within traveling distance of the test site.
Begins October 2006; no enrollment closing date has been set.
Dr. Lesley Allen is recruiting participants who are bothered by
multiple, persistent physical symptoms (such as pain, fatigue,
gastrointestinal difficulties or menstrual difficulties) OR
participants who have Fibromyalgia, Irritable Bowel Syndrome, Chronic
Fatigue Syndrome, Temporo-Mandibular Joint Disorders, or Chemical
Sensitivities for a free treatment study:
To examine a new psychosocial treatment designed to help reduce physical discomfort.
Based on the idea that stress tends to make physical symptoms worse,
the program teaches stress management and coping skills as a way to
reduce physical discomfort.
Applicants must be between the ages of 18 and 65 and must be
experiencing multiple, unexplained physical symptoms. Medications must
be stable for at least two months, and applicants must not be involved
in (or be willing to delay) psychotherapy treatment during the
four-month duration of the study.
The 14 weekly sessions will be offered at no cost to participants. They will be compensated $20 for each completed assessment.
For more information, contact Jade Tiu, Research Coordinator, tiuje@umdnj.edu
(732) 235-3378; 671 Hoes Lane, Piscataway, NJ 08854
4) Insomnia Medication Trial or FM Patients
Robert Wood Johnson Medical School, central NJ.
Study subjects must live within traveling distance of the test site.
Begins October 2006; no enrollment closing date has been set.
Dr. Lesley Allen at is recruiting Fibromyalgia patients who are also experiencing sleeping difficulties for a medication study:
To examine the effects of a sleep medication as a treatment for insomnia and Fibromyalgia symptoms.
Applicants must be between the ages of 18 and 64, have been diagnosed
with Fibromyalgia, and be stable on medications for at least one month.
Additionally, applicants must not be involved in (or be willing to
delay) psychotherapy treatment during the duration of the study.
The study involves 7 visits for approximately 4 months. All study pills
and procedures are free of charge and participants will be compensated
$20 for each completed visit.
For more information, contact Jade Tiu, Research Coordinator, tiuje@umdnj.edu
(732) 235-3378; 671 Hoes Lane, Piscataway, NJ 08854
5) Study of Ampligen in Chronic Fatigue Syndrome: Recruiting Once Again
http://www.clinicaltrials.gov/ct/show/NCT00215813
Updated October 24, 2006. Still recruiting in 2009
Sharon Conway
215-988-0080
sharon@hemispherx.net
Study chairs or principal investigators
Daniel Peterson, M.D., Principal Investigator, Sierra Internal Medicine, NV
Lucinda Bateman, M.D., Principal Investigator, Fatigue Consultation Clinic, UT
Charles W. Lapp, M.D., Principal Investigator, Hunter-Hopkins Center, NC
6) A Study of Genetic Risk Factors That May Be Associated
with Chronic Fatigue Syndrome (CFS)
Researchers at the University of Illinois at Chicago and Tufts University are interested in YOU
Dr.
Brigitte Huber of Tufts University and Dr. Renee Taylor of University
of Illinois at Chicago are seeking research participants ages 13-64 for
a study of genetic risk factors that may be associated with
chronic fatigue syndrome. To be eligible, subjects should have
documentation of a diagnosis of either chronic fatigue syndrome or
mononucleosis from a physician.
If interested, please contact
Dr. Renee Taylor at
(312) 996-3412 (office)
or mono@uic.edu.
[The JPG flyer for the study also lists the logos of NIH and Children's Memorial Hospital.]
7) Chronic Fatigue Study Questionnaire Study
University of Utah
Long distance participants welcome.
Do
you have chronic fatigue and are you searching for ways to manage it
better? Have you just begun treatment with a new physician?
If yes, then medical researchers at the University of Utah invite you
to participate in a research project. They want to study patients with
chronic fatigue as well as the various methods that are currently being
used to treat it. It requires you to complete 2 questionnaires, one
before you start your treatment and another in about 6 months. It takes
about 35 minutes of your time. Through this project, the researchers hope to find better ways of
treating chronic fatigue. If you are interested in participating
in this study and need more information please contact
Kate Hak, Research Coordinator, Health Services Research, University of Utah, at
(801) 587-4741 or email kate.hak@hci.utah.edu.
There will be no costs to you for participating in the study.
We
will send you $25 if you complete two questionnaires, one given to you
at the time you enroll and a second given to you three months later. We
will send another $25 to you for completing a questionnaire six months
after you enroll. If you need to get results of your laboratory tests
from physicians other than the physician who told you about this study,
we will give you an additional $15 for giving us the results of all of
these tests.
See also
http://clinicaltrials.gov/ct2/show/NCT00983502
Added 10-2-08.
Email address and contact name updated 12-09.
8) Vulvodynia - Cost of Illness Survey
The
NVA is seeking women with vulvodynia who live in the United States to
participate in a cost of illness survey, which asks questions about
lost work hours and out-of-pocket expenses related to having
vulvodynia. From a cost of illness survey, analysts can calculate to
what extent a particular health condition impacts our economy. It is
important for NVA to have this information to convince members of
Congress and NIH staff of the great need to increase funding of
vulvodynia research.
Participation requires only 3 hours
of your time over the next 6 months. With the use of a NVA-supplied
calendar, you will keep track of your vulvodynia-related expenses, such
as prescription medications, doctor visits and over-the-counter
remedies. Participants will anonymously log onto NVA's web site once
every four weeks (for six months) to record expenses. Each time you log
on, the survey will take 5-10 minutes to complete.
For additional information, or to participate, please visit http://www.nva.org/costsurvey
(Study Announced 9/24/08)
9) Fibromyalgia with Sleep Disturbances - medication trial
Raleigh, NC
Added Aug 20, '09
http://centerwatch.com/clinical-trials/listings/studydetails.aspx?StudyID=157049
Balance is a condition inherent to nature, but balance is hard to achieve in everyday life.
Occasional
lack of sleep can affect your overall well being. But if you frequently
wake up in the morning, after a night of fitful or disturbed sleep,
with widespread muscle pain that lasts through the day, you could have
a condition called Fibromyalgia.
Qualified participants will receive
study medication and all study-related tests are no cost and may be
compensated for time and travel.
You may qualify for this study if:
You are between the ages of 18 to 64
Maintain a normal daytime/awake, nighttime/asleep schedule including 6 ½ to 8 hours in bed at night
Have
been diagnosed with Fibromyalgia, or regularly experience the symptoms
associates with the condition, including muscle pain, stiffness,
headache and fatigue
Have experienced difficulty sleeping for least three days out of the week
Patient Exclusion Criteria: over age 64
Wake Research Associates
3100 Duraleigh Road, Suite 304
Raleigh, NC 27612
Phone: 919-781-2514
EMail: cmoore@wakeresearch.com
10) Fibromyalgia, Juvenile - Clinical Trial Testing the Safety and Efficacy of Fluoxetine
Cincinnati, OH
Added Aug 20, '09
Long distance participants welcome.
http://www.clinicaltrials.gov/ct2/show/NCT00115804
Contact: Megan Clayton 513-475-8113 claytoma@ucmail.uc.edu
Detailed Description:
Fibromyalgia
is a common condition that is often challenging to treat. It is defined
by the American College of Rheumatology (ACR) as widespread pain of at
least 3 months duration in combination with tenderness at 11 or more of
18 specific tender point sites on the body. The prevalence of JPFS in
children and adolescents in the general population of the United States
is unknown. Studies from Israel, Mexico, and Italy have estimated that
the prevalence rate of JPFS in school children ranges from 1.24% to
6.20%, with girls making up the majority of cases. Information from a
national registry in the United States indicates that JPFS accounts for
about 7.7% of new patient diagnoses in a pediatric rheumatology
setting. The mean age of onset of pediatric JPFS is 12 years.
As
in adults, JPFS has been diagnosed in children and adolescents using
the ACR criteria. JPFS often leads to substantial morbidity and
disability. For example, adolescents with JPFS reported significantly
greater functional disability and greater number of school absences
than those with other rheumatic diseases such as juvenile RA or lupus.
The presence of high levels of pain and disability at this critical
developmental stage place adolescents with JPFS at greater risk for
long term social and occupational difficulties. Early diagnosis and
effective intervention are therefore of critical importance.
Inclusion Criteria:
Female or male outpatients 13 to 18 years of age.
Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
Ability to understand and cooperate with study procedures.
Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.
11) Coping Skills Training for Adolescents With Fibromyalgia
Kentucky and OH
Added Aug 20, '09
Long distance participants welcome.
Juvenile
fibromyalgia is a chronic pain condition that can cause considerable
suffering and difficulty in an adolescent's day-to-day activities. The
purpose of this study is to determine whether coping skills training,
when combined with usual medical care, can reduce pain and disability
in adolescents with fibromyalgia.
Study hypotheses: 1)
Adolescents who receive coping skills training combined with their
usual medical care will show significantly greater reductions in
functional disability, pain, and depressive symptoms at the end of the
acute treatment phase than adolescents who receive fibromyalgia
education with their usual medical care. 2) Adolescents who receive
coping skills training with their usual medical care will show
significantly lower levels of functional disability, pain, and
depressive symptoms at the end of a six-month maintenance phase than
adolescents who receive fibromyalgia education with their usual medical
care.
http://www.clinicaltrials.gov/ct2/show/NCT00086047
Inclusion Criteria:
Diagnosis
of JPFS based upon widespread pain for over 3 months, at least 5 tender
points, and associated features such as sleep difficulty, fatigue, and
abdominal discomfort
Average pain intensity greater than 4 on the Visual Analog Scale
Functional disability score greater than 7
Stable medications for 8 weeks prior to study entry
Contact: Susmita Kashikar-Zuck, PhD 513-636-6337 Susmita.Kashikar-Zuck@cchmc.org
Kentucky and OH
12) Autonomic Nervous System and Chronic Fatigue Syndrome (CFS&ANS) (POTS)
Vanderbilt University, Nashville, TN
Added Aug 20, '09
The
investigators propose to test the hypothesis that the sympathetic
nervous system contributes to the cardiovascular and inflammatory
abnormalities present in the chronic fatigue syndrome (CFS) and, in
particular in the subset of patients characterized by postural
tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise
normal young women, and are the cause of significant disability. A
substantial proportion of patients referred for evaluation of POTS met
diagnostic criteria for CFS and, conversely, a subset of patients
referred for treatment for CFS have POTS. The investigators hypothesize
that sympathetic activation underlies the pathophysiology of patients
in whom CFS and POTS overlap (CFS-P).
Other: Autonomic Function Tests
Other: Saline infusions
Drug: L-NMMA trimethaphan
Drug: methyldopa
Opened Dec 2007, still recruiting 8/09
http://clinicaltrials.gov/ct2/show/NCT00580619
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Meet CDC diagnostic criteria of CFS (Fukuda et al., 1994)
Meet diagnostic criteria of POTS (Raj et al., 2005)
Age between 18-65 years
Male and female are eligible (although the majority of patients with CFS-P are female)
Contact: Ginnie Farley, RA adcresearch@vanderbilt.edu
13) Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
University of Virginia, Charlottesville, VA
Added Nov '09
Detailed Description:
Central
pain networks in the brain are dysregulated in persons with
fibromyalgia (FM). Thus, the investigators propose that cranial
electrical stimulation (CES) that works on the brain may ameliorate
symptoms of FM by interacting with the central pain networks. The
specific aims of this randomized, controlled, three-group pilot study
design are to: (1) determine differences in pain over time between the
active CES, sham device, and usual care (UC) groups; (2) explore
differences in brain activity in pain processing regions (i.e.,
cingulate, insula, prefrontal and somatosensory cortices, amygdala, and
thalamus) between the active CES, sham device, and UC groups in a
subset of 12 participants (6 in each device group); (3) determine the
effects of CES on other symptoms (fatigue, sleep disturbances,
depression, perceived stress) and functional status, and blood pressure
over time between the active CES, sham device, and UC groups; and (4)
determine the amount of influence that selected psychological factors
(negative affect, catastrophizing, and other personality
characteristics) have on group differences in pain, other symptoms,
functional status, and brain activity.
http://clinicaltrials.gov/ct2/show/NCT00928720
Inclusion Criteria:
meet the diagnostic criteria for FM established by the American College of Rheumatology
have initial pain level equal to or greater than 3 on a NRS 0-10
have stable medication use related to FM for at least 4 weeks
be able to read, write, and understand the English language
Exclusion Criteria (all participants):
pregnant or breastfeeding
epilepsy or history of seizures
presence of pacemakers and/or other implanted devices
Exclusion Criteria (subset of 12 participants who wil have fMRIs)
conditions
that would not permit an fMRI (e.g., certain types of metal or metallic
objects in body, diaphragm or intrauterine device, dermal patches, ear
or eye implants, implanted electrical stimulators, artificial heart
valve, implanted catheter or tube, tattoos, claustrophobia; or weight
more than 275 lbs)
Contact: Principal Investigator:
Ann G Taylor,
EdD, RN
434-924-0113 cscat@virginia.edu
Contact: Cheryl Bourguignon, PhD, RN 434-924-0082 cb2n@virginia.edu
Additional information from one of our members who is participating:
The
device being tested is an “Alpha Stim 100” which you can find out about
on the internet. the contacts that they have listed there are not the
person who you need to talk to – took me some time to get to the right
person. She is very nice! Her name is Shannon Riedel, slr3q@virginia.edu. Her # is 434-982-0724. Leave a message, and she will call back. She is at the UVA School of Nursing in the Center for the Study of Complementary & Alternative Therapies.
Selected International ME/CFS and FMS Trials - Includes Web Questionnaire SurveysJune 2010 - Perceived Contributing Factors, Locus of Control and Self-Efficacy of Female Fibromyalgia Patients
March 2010 - Clinical Trial Participant Survey - Do people join studies for health care?
March 2010 - How perceived doctor empathy is defined & its impact on those with CFS/ME?
2009-2010 - Cancer After Other Conditions
Oct 2009 - FM Wellness Project
Aug 2009 - Questionnaire - University of Utah - Chronic fatigue
Aug 2009 - Questionnaire - Florida Institude of Technology - Chronic fatigue
Sep 2008 - Questionnaire - FM Assoc. UK - Fibromyalgia Patients with Cognitive Problems
June 2010 - Perceived Contributing Factors,
Locus of Control and Self-Efficacy of Female Fibromyalgia
Patients
Dear Participant,
You are invited to
participate in the research project entitled “Perceived Contributing
Factors, Locus of Control and Self-Efficacy of Female Fibromyalgia
Patients”, which is being conducted at the University of Toledo under
the direction of Sara Holl (student investigator) and Dr. Sharrel Pinto
(faculty advisor). You were contacted a few months ago regarding
your interest in taking an online survey regarding your beliefs about
fibromyalgia for my thesis. We would greatly appreciate input
from yourself and other members of your support group.
The following link will take you to the survey. [https://www.surveymonkey.com/s/CMSJWJW]
It is designed to take approximately 10-15 minutes to complete.
There are very minimal risks to participating in this study. The
researchers will make every effort to prevent anyone who is not on the
research team from knowing that you provided this information or what
the information is. All responses will be anonymous and
information will be kept confidential. In order to preserve
confidentiality, no personal information will be collected for this
survey.
The only direct benefit to you if you participate in
this research may be that you will learn about how pharmacy healthcare
administration experiments are run and may learn more about patients’
beliefs about fibromyalgia. Others may benefit by learning about
the results of this research. Your refusal to participate in this study
will involve no penalty or loss of benefits to which you are otherwise
entitled. In addition, you may discontinue participation at any time
without any penalty or loss of benefits.
Please forward this
link on to all members who are interested in participating. We
will send the results of the survey to the group leaders who can share
the information with their members. We appreciate your
participation.
All group leaders: please [write]l with
the approximate amount of members you forwarded the survey on to and/or
if you posted the link on a webpage. This will help to calculate
an accurate response rate. I appreciate it!
Before you
decide to accept this invitation to take part in this study, you may
ask any questions that you might have. If you have any questions
at any time before, during or after your participation you should
contact Sara Holl at sara.holl@rockets.utoledo.edu.
If you have questions beyond those answered by the research team or
your rights as a research subject or research-related injuries, please
feel free to contact Dr. Jeffrey Busch, research compliance coordinator
at (419) 530-2844.
By completing the survey, you are providing your informed consent to participate in this research project.
Please click https://www.surveymonkey.com/s/CMSJWJW to take the survey. Thank you!
Sara Holl
Research Assistant
Pharmaceutical Care and Outcomes Research (PCOR) Lab
University of Toledo
419-530-1970
sara.holl@rockets.utoledo.edu
March 2010 - March 2011 - CLINICAL TRIAL PARTICIPANT SURVEY
The
purpose of this study is to determine if some people join clinical
trials to receive access to healthcare. This work will help
researchers better understand the links between access to healthcare
and clinical trail participation.
This study is being
conducted by a researcher Carrie M. Lee MBA, a doctoral student at
Walden University, carrie.lee@waldenu.edu. Dr. Leilani Endicott is the
Walden University representative who can discuss further questions,
1-800-925-3368, extension 1210.
Walden University’s approval number for this study is 03-18-10-0363696 and it expires on March 17, 2011.
If
you have participated in a clinical trial in the past year, or are
currently participating in a clinical trial you are invited to
participate in a web survey at
http://www.makesurvey.net/cgi-bin/survey.dll/F688F42CE1DB4763B28F4B88FC5F6C34
No Identifying information is collected in this survey, and results are only used for this research project.
March 2010
How perceived doctor empathy is defined & its impact on those with CFS/ME?
How understanding is your Doctor?
Do you suffer from CFS / ME and want your views heard?
I am an MSc student at the University of St Andrews currently
researching the experiences of those with CFS/ME, with particular emphasis
on the role of patient-provider communication. This brief online
questionnaire aims to look at whether there is any direct impact from the
experiences you may receive from within your primary health care contact
on you, as someone with CFS/ME.
It is hoped that this study will illustrate the impact of understanding
CFS/ME within the healthcare profession in order to tailor training for
future physicians.
If you are still interested, please click on the link below:
http://www.surveymonkey.com/cfsonlinesurvey
Thank you!
Ceara Hayden
cearahayden@googlemail.com
If you have more questions directly relating to the study, feel free to contact:
Prof Gerry Humphris,
The Bute Medical School,
University of St Andrews,
Bute Building,
St Andrews
KY16 9TS
Scotland
gmh4@st-andrews.ac.uk
2009-2010 - Cancer After Other Conditions
THE UNIVERSITY OF TEXAS AT AUSTIN SCHOOL OF NURSING
Are you a cancer survivor who had limitations in activities of daily living prior to your cancer?
I
invite you to participate in a study to help us understand how cancer
survivors who had a functional limitation or disability prior to being
diagnosed with cancer take care of their health. You can earn up to $
25 by completing a questionnaire packet. If you are over the age
of 21, and interested in participating in this study, please complete
the information requested on this page, fold it so the envelope on the
back is showing, and mail it back to me. You can also fax it to
512-475-8755 or call 1-800-687-8010 (free), 512-232-3492. You must have
completed active treatment to participate.
Heather Becker, Ph.D. -- The University of Texas at Austin, School of Nursing
heatherbecker@mail.utexas.edu
Send
What is your cancer diagnosis? ______________________________
Have
you completed active
treatment? ____
yes ____ no
Are you
limited in any way in any activities because of physical, mental, or
emotional problems?
____ yes ____ no
Did
this functional limitation exist PRIOR to your cancer
diagnosis? ____
yes ____ no
Name______________________________ Email____________________
Address____________________________________________________
City/State/Zip_______________________________________________
Phone ________________________ Date of Birth ____/____/_______
See also,
http://www.utexas.edu/nursing/html/research/news/09/cancer.html
Oct 2009 - FM Wellness Project
http://www.fmwellness.org/index.htm
The
Fibromyalgia Wellness Project is a research study sponsored
by NIAMS of NIH. This project is conducted by Collinge and
Associates, an independent research group directed by William Collinge,
PhD.
Description
One way the person with FM may be
able to have significant impact is through the careful management of
lifestyle and behavior factors that affect symptom levels. However,
since each person is unique, management of FM needs to be highly
individualized.
Because there are so many options and influences
to consider, one challenge is discovering what strategies work best.
The purpose of the FM Wellness Project is to evaluate a completely
individualized approach to symptom reduction. The goal is to empower
users with uniquely personal insights into what strategies work best
for them over time.
Participation involves visiting this website
several times each week, about 5-10 minutes each time, to complete the
SMARTLog. “SMART” is an acronym meaning Self-Monitoring and Review
Tool. Like a diary, the SMARTLog records your activities, treatments,
strategies, stresses, other inputs you want to evaluate, and your
symptom levels for the past 24 hours.
By completing the SMARTLog
several times each week you build a personal database over time. This
project is pioneering a new statistical analysis approach that will
evaluate your personal data each week to discover patterns of
connection between your inputs and your symptom levels. When these
patterns are found they are reported to you in your unique SMART
Profile. The purpose of SMART Profile is to give you accurate,
personalized feedback based on your own data, and no one else’s, about
what inputs lead to reduced symptom levels for you.
Benefits
You may discover new ways to reduce your symptoms and improve the quality of your life.
You will be contributing to knowledge that may help others living with fibromyalgia.
Eligiblility
Adults (over 18) with fibromyalgia.
You must be able to read English and complete the assessment forms on this website.
You must have daily access to the internet at home to use SMARTLog.
The Consent Form which gives full details about participation.
Aug 2009 - Questionnaire - University of Utah - Chronic fatigue
Individuals
who have had severe, unexplained fatigue for at least six months and
who have no serious abnormalities on medical tests are wanted for a
study of chronic fatigue. Patients who qualify for the
study will be asked to complete three questionnaires over a six month
period. Participating in the study will not alter the treatment
that your physician gives you. The purpose of the study is to
evaluate whether patients treated by certain types of physicians
improve faster than patients treated by other types of
physicians. If you may be interested in participating in this
study, please contact the study coordinator, Kathleen O’Connor at (801)
587-4741. For more information email kathleen.oconnor@hci.utah.edu or visit our website at https://hci-as2.hci.utah.edu/CFSurvey/app.
[An excerpt under the "About" section at the given website:
"There will be no costs to you for participating in the study.
We
will send you $25 if you complete two questionnaires, one given to you
at the time you enroll and a second given to you three months later. We
will send another $25 to you for completing a questionnaire six months
after you enroll. If you need to get results of your laboratory tests
from physicians other than the physician who told you about this study,
we will give you an additional $15 for giving us the results of all of
these tests."]
Kathleen O'Connor, MSc
Research Coordinator, Health Services Research Dept.
Huntsman Cancer Institute
University of Utah
Salt Lake City, UT
84112-5550
Ph: (801) 587-4741
Aug 2009 - Questionnaire - Florida Institude of Technology - Chronic fatigue
The
National Chronic Fatigue Survey, an internet-based survey of fatigue
related to chronic illness, has been launched by the Fatigue Management
Institute of Florida Institute of Technology. The survey is
designed to gather information on the nature and impact of fatigue
associated with chronic medical disorders. The survey findings
will be used to better describe the experience and severity of fatigue
related to chronic medical conditions and will contribute to the
development of improved techniques for managing fatigue.
The Survey is open to adults with a chronic medical condition, can be completed anonymously, and can be accessed at: http://research.fit.edu/fmi
-- Summaries of findings will be posted on FIT web site following close of the survey.
-- The data collected is for research purposes only.
-- Participants' personal information will remain completely confidential.
--
Please aid us in developing a better understanding of fatigue in
chronic medical conditions and in the eventual improvement of
treatments and techniques for managing fatigue.
About the Fatigue Management Institute:
The
Fatigue Management Institute serves as a focal point for integrating
emerging research findings with techniques for day-to-day management of
fatigue. The Institute conducts research on fatigue and fatigue
management interventions, provides fatigue management training, and
disseminates summaries of research findings related to fatigue and its
management in chronic medical conditions. The institute is part
of the School of Psychology at Florida Institute of Technology and has
no commercial interests. For further information contact Dr. Thom
Harrell - tharrell@fit.edu
________________________________________________________________
School of Psychology
Florida Institute of Technology
150 West University Boulevard
Melbourne, FL 32901-6975
(321) 674-8104
Web-based Study Needs Fibromyalgia Patients Who Experience Cognitive Problems
(Cognitive problems AKA "Fibrofog")
September
20, 2008: Fibromyalgia patients who experience cognitive problems (AKA
“fibrofog”) are invited to take part in an international
e-mail-based doctoral research survey based at the University of West
England.
Online completion of answers to study questions is expected to require about 15 minutes, and participants will remain anonymous.
The
resulting findings should help to develop a more evidence-based
understanding of the level of FM patients’ cognitive problems,
considering other details of their health status, and how they cope
with cognitive changes.
Requirements to participate include:
• Diagnosis of fibromyalgia
• Cognitive problems
• 18 years of age or older
• Computer access
•
Ability to log into a website, create a password and retain it for
re-entry,
and complete answers to an online questionnaire and questions.
• No head injury, CFS or ME, current or past cerebral disease.
If
you are interested in taking part in this study and would like to see
the study website, or want more details before deciding – go to
the
Fibromyalgia Association UK website (http://www.fibromyalgia-associationuk.org),
where
the study announcement is posted, and click on a link to e-mail the
researcher – Pascale Harrison. In turn she will forward a link to
the study website.
Note: Another online survey announcement
on the FibromyalgiaAssociationUK.org website – this one limited
to female FM patients in the south east of England to ensure manageable
size - will develop data on the effects of certain foods or food groups
among FM patients. To read the announcement and download the survey,
click here.
|