Fibromyalgia: An Environmental Scan

Table of Contents

APPENDIX L-b

ADDITIONAL RESEARCH STUDIES FIBROMYAGIA

Canada
Title of Trail A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome
Date Start Date: April 2007  Estimated completion September 2009
Primay Contact Alexander W McIntyre, FRCPC
Email: dramcintyre@telus.net
Phone: 250 492 0053
Purpose To compare the efficacy of Quetiapine SR versus placebo over 8 weeks in unipolar non-psychotic adult outpatients depression and comorbid fibromyalgia. This will be measured by the last observation carried forward (LOCF) mean change from baseline to week 8 on the Hamilton Depression Scale (HAM-D) total score. For the purposes of this study, response regarding improvement in depressive symptoms will be defined as a 50% decrease in HAM-D scores over 8 weeks. Furthermore, proportion of patients achieving remission is defined as an HAM-D total score of 7 at end of treatment. The anxiety comorbid symptoms often associated with major depression will be assessed with the HAM-A (14 items) scale. Proportion of patients responding and achieving remission of anxiety symptoms are defined respectively as a reduction of 50% in the HAM-A total score from baseline and a HAM-A total score of 7 at the end of treatment.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy219668.aspx
Title of Trail Effects of Pregabalin (Lyrica) on Sleep Maintenance in Subjects With Fibromyalgia
Date Start Date: June 2009 Estimated study completion Oct 2010
Primay Contact Pfizer CT
1-800-718-1021
Purpose The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy317807.aspx
Title of Trail Qigong For Treatment Of Fibromyalgia
Date Start Date: August 2009 Estimated study completion August 2010
Primay Contact Pain Management Unit – CDHA Halifax, Nova Scotia, Canada
Purpose Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain and hyperalgesia with a prevalence of 2-4% in the general population; it is often accompanied by fatigue, insomnia, anxiety, depression and other conditions. It is a difficult condition to treat, and only recently have drugs been approved by the FDA specifically for the treatment of this condition (Lyrica was approved in 2007, Duloxetine in 2008). There are now several clinical trials of drugs commonly used to treat neuropathic pain (amitriptyline, gabapentin, pregabalin, acetaminophen/tramadol, duloxetine, minserin) reporting some degree of efficacy in treating fibromyalgia. This efficacy makes it practical to consider fibromyalgia along with other neuropathic pain conditions. However, such drug trials report only partial efficacy in relieving pain and/or other symptoms. Current treatment recommendations indicate the need for a multimodal approach; this includes medical management using appropriate drug therapies, psychological therapies, exercise and complementary approaches. The current proposal is for a randomized controlled trial to compare qigong (a complementary modality) to a wait list control to determine if qigong is a useful complementary therapy for fibromyalgia.  The investigators recently completed a pilot trial in which they examined a specific form of qigong (CFQ Qigong, available locally in Halifax), and observed beneficial effects against pain, fibromyalgia impact, and on quality of life scores; importantly, these benefits were all sustained for 6 months to the end of the trial. On the basis of these preliminary observations, the investigators now propose a controlled trial in which CFQ Qigong is compared to a wait list control group. The latter group will be offered qigong training at the end of the trial, so could really be characterized as a delayed treatment group. The study will consist of a 3-day training period, weekly review of technique sessions for 8 weeks, daily practice for 8 weeks, with assessments at baseline, at 8 weeks following the training and practice, and follow-up assessments at 4 and 6 months. Study outcomes will include: (a) pain (numeric rating scale – pain intensity), (b) impact (fibromyalgia impact questionnaire), (c) quality of life measures (SF-36), (d) patient assessments (patient global impression of change and satisfaction scales), (e) sleep measures (Pittsburgh sleep quality index, actigraphy, sleep diary). In addition to these assessments, the investigators will also conduct qualitative assessments in which participants provide a more open-ended assessment of their health status at these same intervals. The main hypothesis being examined is that CFQ Qigong will produce benefits compared to the wait list group.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy301954.aspx
Title of Trail Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic
Musculoskeletal Pain
Date Start Date:  August 2005
Primay Contact Nicolette S Bradley, BSc
Email: nicolette.bradley@sickkids.ca
Phone: 416-813-8925
Purpose This study is comparing two different exercise programs, Qi Gong (gentle stretching, and breathing) with an aerobics program (boxing and dancing) to see if children with chronic pain or fibromyalgia are able to take part in the program. We would also like to know if it is easy to take part in an exercise program. We hypothesize that children with chronic musculoskeletal pain and FM, who engage in Qigong fitness training, will be more compliant, and have an equivalent or possibly superior improvement on measures of motor function (peak power, endurance, and metabolic efficiency) compared to children given an aerobic fitness exercise program.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy140665.aspx
 
Title of Trail Quetiapine (Seroquel XR) for the Treatment of Fibromyalgia: a Clinical and
Mechanistic Pilot Study
Date Start Date: April 2008 Estimated study completion January 2010
Primay Contact Veronique Dagenais, Nurse
Email: vdagenais.chus@ssss.gouv.qc.ca
Phone: 819-346-1110
Purpose This is a double-blind, randomized, placebo-controlled trial measuring the impact of quetiapine on clinical and experimental measures of pain in fibromyalgia and its biochemical correlates.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy352464.aspx
Germany
Title of Trail Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in
Chronic Functional Pain
Date Start Date: September 2005 Estimated study completion November 2007
Primay Contact Dieter Kleinboehl, Dr. phil.
Email: kleinboehl@osi.uni-mannheim.de
Phone: +49 621 181 2111
Purpose The project investigates on the role of pain avoidance, comorbidity and stress response for the development of chronic somatic and visceral pain. We, the researchers at University Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central mechanism of the process of pain becoming chronic, which is augmented by fear and by avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are further promoting factors in chronic pain development.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy130919.aspx
 
Title of Trail Effects of Pregabalin (Lyrica) on Sleep Maintenance in Subjects With Fibromyalgia
Date Start Date: June 2009 Estimated study completion Oct 2010
Primay Contact Pfizer CT
1-800-718-1021
Purpose The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy364753.aspx
Title of Trail Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and
Chronic Back Pain
Date Start Date: August 2005 Estimated study completion August 2008
Primay Contact Christoph Konrad, MD, PhD
Email: christoph.konrad@anaes.ma.uni-heidelberg.de
Phone: 0049 621 383 2608
Purpose It is known, that a so called “pain memory” usually evolves in chronic pain syndromes which both aggravates the disorder and modifies the patients pain perception. Thus, the principal object of pain therapy is to “delete” this dysfunctional pain memory. The combination of medication, physiotherapy and psychological therapy seems to be the most effective treatment. This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on the effectiveness of behavioral therapy. It is hypothesized that the combination of behavioral therapy and Dronabinol will be most effective in deleting the pain memory.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy129030.aspx
France
Title of Trail Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain
Disorders
Date Start Date: October 2006 Estimated study completion January 2010
Primay Contact Nadine ATTAL, MD, PHD
Email: nadine.attal@apr.aphp.fr
Phone: 33 1 49 09 59 31
Purpose Objectives : To investigate the analgesic effects of repeated sessions of unilateral rTMS in patients with chronic pain syndrome due to fibromyalgia, IBS or burning mouth syndrome. Primary outcome will be numerical pain scores on the patient’s self diaries. Methods : The study will be randomized and performed in parallel groups and double blind versus sham stimulation, and will include 90 patients (45 patients per treatment arm). The rTMS will be performed on the right cortical area corresponding to the contralateral arm, 5 consecutive days , then once a week during 3 weeks then twice a month during 2 months, then once a month during 1 year. Clinical assessment will include an assessment of pain, quality of life, sleep, depression and anxiety, catastrophizing, and a neuropsychological evaluation. Conclusion : this study should allow to determine for the first time the long term efficacy and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes which are often refractory to conventional treatments.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy149395.aspx
Title of Trail Improving Quality of Life of Fibromyalgia Patients
Date Start Date: September 2007 Estimated study completion July 2010
Primay Contact Christian GUY-COICHARD, MD
Email: christian.guy-coichard@sat.aphp.fr
Phone: 33(0)149282308
Purpose Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in “Plurifocal educational group” than in control group
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy230853.aspx
Title of Trail Repetitive Trans-Cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
Date Start Date: October 2008 Estimated study completion October 2011
Primay Contact Eric Guedj, MD
Email: eric.guedj@ap-hm.fr
Phone: 49-138-5558
Purpose Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy225956.aspx
Japan
Title of Trail A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients
WithFibromyalgia
Date Start Date: July 2009 Estimated study completion February 2011
Primay Contact Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Purpose This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy363559.aspx
Title of Trail Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients
With Fibromyalgia – NCT00830167-Aoi-ku – 0024
Date Start Date: March 2009 Estimated study completion July 2011
Primay Contact Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Purpose This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Link http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy333848.aspx
Sweden
Title of Trail Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
Date Start Date: January 2008 Estimated study completion February 2009
Primay Contact Kaisa E Mannerkorpi, Ass prof
Phone: 0046313424692
Email: kaisa.mannerkorpi@rheuma.gu.se
Purpose The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.