Fibromyalgia | Open Studies | United States, Pennsylvania | United States, New Jersey | United States, Delaware | Adult. Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients. This study has been completed. Sponsor: Information provided by (Responsible Party): Pfizer ClinicalTrials.gov Identifier: First received: January 5, 2011 Last updated: September 23, 2013 Last verified: September 2013 The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia.
Primary Outcome Measures: Time to loss of therapeutic response based on pain response relative to baseline or patient discontinuation. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ] Inclusion Criteria: Patients must have fibromyalgia. Exclusion Criteria: Patients with other painful conditions cannot participate. Please refer to this study by its ClinicalTrials.gov identifier: NCT01271933 Additional Information: No publications provided Keywords provided by Pfizer: Additional relevant MeSH terms: The Healing Context in Complementary and Alternative Medicine (CAM): Instrument Development and Initial Validation. Primary Outcome Measures: Transcribed focus group information [ Time Frame: Baseline (generally same day as study enrollment, but baseline data collection may occur at a single study visit within 4 weeks of enrollment) ] [ Designated as safety issue: No ]Participants' opinions regarding factors that contribute to healing, such as important patient characteristics, provider characteristics, and environmental factors.
Secondary Outcome Measures: Cognitive Interviews regarding items [ Time Frame: Baseline (generally same day as study enrollment, but data collection may occur at a single study visit within 4 weeks of study enrollment) ] [ Designated as safety issue: No ]Participants will 'think aloud' while answering items in the HEAL item bank. This will provide the investigative team with information on whether item stems, reponse choices, or wording need to be changed so that they can be easily and accurately understood and answered.
Specific Aim 1: Develop an item bank. Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain. Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the muscles in the shoulder where the subject feels pain.
This research study will evaluate the effect of electrical stimulation on shoulder pain. Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Aging Successfully With Pain. Primary Outcome Measures: The Roland-Morris Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]The Roland-Morris Questionnaire is a disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain The Roland-Morris Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The Roland-Morris Questionnaire is a disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.
Among mind-body therapies, there is evidence for an association between pain reduction and mindfulness meditation. The Use of PET/CT to Evaluate Synovitis in the Temporomandibular Joint (TMJ) Primary Outcome Measures: The primary outcome variable will be the presence or absence of 18F-FDG uptake on positron emission tomography combined with computed tomography (CT) of the temporomandibular joint. [ Time Frame: 1 year ] [ Designated as safety issue: No ] This is a prospective, double-blinded, pilot study to evaluate the ability of PET/CT with FDG to detect synovitis of the temporomandibular joint.
Patients presenting to the Department of Oral and Maxillofacial Surgery at the Hospital of the University of Pennsylvania with symptomatic internal derangement of the temporomandibular joint requiring arthroscopy will be compared to control subjects. Key inclusion criteria include any individual found to have a primary diagnosis of internal derangement of the temporomandibular joint requiring arthroscopy as determined by the treating physician. Once a patient has been identified as eligible for the study, the treating physician will contact a member of the study team. Go Clinical Trials - Be notified about a clinical trial in your.
Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials. What is a clinical trial? Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. This is an interventional type study, meaning that you will be assigned by the investigator to a treatment or other intervention (which may include a placebo), and the outcome measured. Why participate in a clinical trial? What happens during a clinical trial? The clinical trial process depends on the kind of trial being conducted.
What is informed consent? National Fibromyalgia Association: Listing of Current Clinical T. Clinical Trials Welcome to the National Fibromyalgia Association Clinical Trials Resource Center, presented in partnership with CenterWatch, the leading publisher of information on clinical research for patients and their advocates and healthcare professionals. Please click on the links below to learn more about clinical research and new medical therapies for treating fibromyalgia and related conditions. About Clinical Research This section provides background information about the clinical trials process and what to expect when you volunteer to participate in a clinical trial. Here, you'll find answers to frequently asked questions about clinical trials and also suggestions for where to find more information.
Listing of Fibromyalgia Trials This is a listing of U.S. and international clinical trials actively recruiting patients for fibromyalgia. Email Notification Service Register your email address to be notified when new fibromyalgia clinical trials are posted to the database. ClinicalTrials.gov. Rheumatology Division Clinical Trials: Main Page. Penn Rheumatology The Division of Rheumatology at Penn Medicine is ranked highest in the Philadelphia region by U.S. News & World Report. Penn rheumatologists are known nationally and internationally for their clinical expertise and research scholarship. Clinical Programs About Penn Rheumatology Penn Rheumatology is a national leader in the diagnosis, treatment and management of patients with systemic autoimmune diseases, all forms of arthritis and other conditions of the musculoskeletal system. Penn rheumatologists are recognized nationally and internationally for their clinical expertise and research scholarship.
Learn more about Penn Rheumatology Related Links Make a Donation. Rheumatology Clinical Trails. Penn Rheumatology The Division of Rheumatology at Penn Medicine is ranked highest in the Philadelphia region by U.S. News & World Report. Penn rheumatologists are known nationally and internationally for their clinical expertise and research scholarship. Clinical Programs About Penn Rheumatology Penn Rheumatology is a national leader in the diagnosis, treatment and management of patients with systemic autoimmune diseases, all forms of arthritis and other conditions of the musculoskeletal system. Penn rheumatologists are recognized nationally and internationally for their clinical expertise and research scholarship. Learn more about Penn Rheumatology Related Links Make a Donation. Tai Chi Mind-Body Therapy for Fibromyalgia - Full Text View - Cl.
Primary Outcome Measures: Fibromyalgia Impact Questionnaire score [ Time Frame: wks 12 and 24 ] [ Designated as safety issue: No ] Secondary Outcome Measures: Tender Point Count, Fibromyalgia Intensity Score, Physicians' Assessments of Fibromyalgia Severity, Sleep Quality, Depression Index, Physical Performance, Self-Efficacy and Health Related Quality of Life [ Time Frame: Wks 12 and 24 ] [ Designated as safety issue: No ] Fibromyalgia (FM) is a common, complex chronic condition marked by diffuse musculoskeletal pain, fatigue, functional impairment, disability, and psychological distress that affects 6-10 million people in the United States (US).
There are currently no satisfactory pharmacological or non-pharmacological treatments for FM. New cost-effective strategies that reduce musculoskeletal pain and improve emotional and physical functioning as well as quality of life in people with FM are urgently needed. This is a pilot randomized controlled trial of Tai Chi for fibromyalgia. Www.MyFibroStudy.com. NFA: Listing of Current Clinical Trials.
Effectiveness of Physical Exercise in Women With Fibromyalgia - A Pilot Study of TMS Effects on Pain and Depression in Patients. In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms. The focus on African Americans is due to the mandate from the funding source (internal), as well as possible higher prevalence of FM in AA women. If recruitment is slow, the PI proposes to open up the study to other groups.
Twenty subjects will be randomized to either sham or active TMS condition. Inclusion/exclusion criteria are well thought out and seem appropriate. mTreatments will be administered at IOP 5 times/wk with each session lasting 20 minutes. Pain intensity and unpleasantness will be measured pre and post each TMS session using three different pain evaluation paradigms. Clinical Trials. Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients. Primary Outcome Measures: pain disability fatigue psychological distress at post treatment and 6 month follow-up Secondary Outcome Measures: passive coping illness cognitions social support at post treatment and 6 month follow-up The fibromyalgia syndrome is a chronic condition with widespread pain that poses a great challenge for patients, rheumatologists and society because of the lack of optimal treatment options.
There is extensive evidence that, in comparison with patients with rheumatoid arthritis, fibromyalgia patients report higher levels of functional disability, pain, fatigue, and lower levels of quality of life. Although effectiveness of pharmacological agents and other interventions is generally limited, most promising effects have been found for non-pharmacological treatments, particularly those with a primary focus on cognitive-behavioral treatment components. However, also these treatment outcomes are characterized by large individual variation.
Fibromyalgia. HRV Biofeedback in Fibromyalgia - Full Text View - ClinicalTrial. A growing body of evidence suggests that the symptoms of many fibromyalgia syndrome (FMS) sufferers might be the result of an imbalance in one of the major stress response systems, the autonomic nervous system. Thus respiratory sinus arrhythmia (RSA) biofeedback, which has shown promise in other conditions associated with an autonomic nervous system imbalance, could be effective in FMS. With the aid of sensors and computers, biofeedback involves modifying and/or learning how to control normally involuntary processes like blood pressure, heart rate and the autonomic nervous system through relaxation and breathing. The goal of this study is to test the effectiveness of a 10-session RSA biofeedback treatment for the symptoms of fibromyalgia. Forty patients receiving the RSA biofeedback treatment will be compared to 40 patients receiving another form of biofeedback thought to be minimally helpful (control group).
Neurotropin to Treat Fibromyalgia - Full Text View - ClinicalTri. This study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles.
Neurotropin has been used in Japan for many years to treat various chronic painful conditions, including fibromyalgia. Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be eligible for this study. Patients must have a history of widespread pain for more than half of the days in each of the three months before they enter the study. Candidates are screened with a medical history, physical examination, blood and urine tests, questionnaires and an electrocardiogram (EKG). Participants take their usual medications for fibromyalgia in addition to either neurotropin or a placebo (look-alike medicine with no active ingredient).
Eszopiclone in the Treatment of Insomnia and Fibromyalgia - Full. Primary Outcome Measures: Total sleep time (TST) as recorded in patient diaries [ Time Frame: week 12 ] [ Designated as safety issue: No ] Secondary Outcome Measures: Wake time after sleep onset (WASO) [ Time Frame: week 12 ] [ Designated as safety issue: No ] Sleep quality [ Time Frame: week 12 ] [ Designated as safety issue: No ] Clinician-rated overall severity of fibromyalgia [ Time Frame: week 12 ] [ Designated as safety issue: No ] Fibromyalgia Impact Questionnaire [ Time Frame: week 12 ] [ Designated as safety issue: No ] Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome.
Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Exercise-Based Motivational Interviewing for Fibromyalgia - Full. Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults. Benefits of Tanning in Fibromyalgia Patients - Full Text View -