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Myofascial Pain Syndromes clinical trials

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NCT ID: NCT03582085 Withdrawn - Fibromyalgia Clinical Trials

Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia

Start date: January 1, 2022
Phase: Phase 2
Study type: Interventional

The investigators are doing this research study to explore whether the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. The researchers believe that the BCG vaccine can benefit people with fibromyalgia by increasing immune signaling molecules, called cytokines. The Faustman Immunobiology Laboratory has previously studied BCG in long term type 1 diabetics, and found that BCG vaccinations showed a short and small pancreas effect of restored insulin secretion. Eligible volunteers will be vaccinated with BCG in repeat fashion over a period of three years or receive placebo treatment. The investigators hypothesize that these repeat injections of BCG will reduce symptom severity by increasing immune signaling cytokines.

NCT ID: NCT02987855 Withdrawn - Fibromyalgia Clinical Trials

Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia

ADcSVF-CRPS
Start date: December 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and Fibromyalgia represent progressive systemic pain conditions which often worsen over time. They appear to be dysregulation of the central nervous system (CNS) and the autonomic system (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and disabilities. They are often associated with injury sites (including surgical) which produce constant, often disabling pain and motor-sensory losses. Treatments are often ineffective and include medications (often high dose opiates), Physical Therapy (PT), and surgical interventions (sympathectomy, ablation) or insertion stimulators of the CNS. Study is an interventional study to document the safety and efficacy of use of adipose-derived cellular stromal vascular fraction (AD-cSVF) in chronic pain and dysfunction disease groups.

NCT ID: NCT02866461 Withdrawn - Fibromyalgia Clinical Trials

Endogenous Opioid Systems and Symptom Change in Fibromyalgia

Start date: November 2021
Phase:
Study type: Observational

This study is designed to study brain mechanisms associated with symptoms and severity of Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported and objective measures of disease severity.

NCT ID: NCT02717585 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Effect of CPAP on Symptoms of Patients With Fibromyalgia and Obstructive Sleep Apnea

FM-OSA
Start date: December 2018
Phase: N/A
Study type: Interventional

Fibromyalgia (FM) is a chronic pain disorder associated with a wide spectrum of sleep disorders. In fact, insomnia and waking unrefreshed are currently considered part of the criteria for diagnosis. Recent studies show that sleep quality and symptoms of FM are inversely correlated. Obstructive sleep apnea (OSA) is a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway. Nonrestorative sleep and fatigue are common symptoms of FM and OSA and may suggest related pathophysiology or co-morbidity that is yet to be diagnosed. This prospective randomized controlled clinical trial will enroll adult FM patients who screen positive for OSA by the STOP-Bang questionnaire. OSA will be confirmed by a laboratory polysomnography (PSG) study. After undergoing further baseline questionnaires and investigations, patients confirmed to have FM with moderate to severe OSA will be randomized to one of two different treatments: 1) Treatment for FM at the Chronic Pain Clinic together with Continuous Positive Airway Pressure (CPAP) devices for their OSA OR 2) Control group receiving treatment for FM at the Chronic Pain Clinic only.

NCT ID: NCT02581332 Withdrawn - Fibromyalgia Clinical Trials

The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of a brief mindfulness meditation intervention on clinical and experimental pain in fibromyalgia (FM) patients as compared to a wait-list control condition. Based on prior research, investigators' working hypothesis is that this intervention will decrease the severity of FM-associated clinical pain and experimentally induced pain in comparison to pre-intervention scores and a wait-list control group. Additionally, based on prior work, investigators postulate that mindfulness meditation training will decrease a) depression, b) state anxiety, c) overall disease severity, and d) perceived stress, while increasing e) quality of sleep, and f) mindfulness skills in comparison to pre-intervention scores and the wait-list control group. Investigators will also be testing if decreases in pain ratings during meditation correspond to increases in parasympathetic activity. The relative systemic contributions of the parasympathetic and sympathetic branches of the Autonomic Nervous System (ANS) can be examined by measuring heart rate variability (HRV), or the variability in the beat-to-beat interval. Fast acting, parasympathetically-mediated high frequency (HF) changes in heart rate variability (HF HRV; 0.15-0.40 Hz) provide a reliable indicator of parasympathetic activity. Importantly, decreased HF HRV correlates with increased pain. Investigators therefore will employ psychophysical and physiological methodologies to test the hypothesis that the analgesic effects of mindfulness meditation in FM patients are associated with increases in HF HRV.

NCT ID: NCT02332694 Withdrawn - Fibromyalgia Clinical Trials

Whole Body Hyperthermia (WBH) as a Rapid Treatment for Fibromyalgia

Fibro and WBH
Start date: February 2015
Phase: N/A
Study type: Interventional

Fibromyalgia has become an increasingly pressing public health problem in the United States. Although some treatments exist for Fibromyalgia, many individuals suffering with Fibromyalgia do not adequately respond to currently available treatment options, highlighting the need to develop and test new interventions for the disorder. To address this pressing clinical issue, we will conduct a pilot study to determine if Whole Body Hyperthermia (WBH) reduces symptoms in adults suffering from Fibromyalgia. We plan to recruit individuals with Fibromyalgia who will receive a single session of WBH to determine if this single session improves Fibromyalgia symptoms and if so whether this improvement will last at least 2 weeks. To do this, the study will include self-report symptom assessments immediately before and one and two weeks after WBH. In addition blood will be collected at these time points to explore whether WBH changes immune system chemicals that are believed to contribute to fibromyalgia. We intend to conduct the study until 10 individuals with fibromyalgia have received a single treatment of WBH and have completed all pre-treatment and post-treatment assessments. Given scientific evidence from our research group that WBH may improve depression, we anticipate that it may also be of benefit or adults suffering from Fibromyalgia.

NCT ID: NCT02202070 Withdrawn - Clinical trials for Temporomandibular Joint Disorders

Botox for Treatment of TMJ Disorder With Bruxism

TMJ
Start date: January 2015
Phase: Phase 1
Study type: Interventional

Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up. The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study

NCT ID: NCT01619566 Withdrawn - Fibromyalgia Clinical Trials

Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed

Start date: June 2012
Phase: Phase 4
Study type: Interventional

Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.

NCT ID: NCT01397006 Withdrawn - Fibromyalgia Clinical Trials

Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

Start date: September 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. the purpose of the study is to see if subjects identified through their primary care physicians who have fibromyalgia and have had symptoms for less than one year respond to pregabalin and to identify characteristics of that response.

NCT ID: NCT01359826 Withdrawn - Fibromyalgia Clinical Trials

The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients

Start date: October 2011
Phase: Phase 4
Study type: Interventional

Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting the physical, social, psychological health and quality of life of patients. Fatigue and pain are aspects of SLE patients which affect their health related quality of life (HRQOL). The purpose of this study is to determine the effect of milnacipran on fatigue in SLE patients with widespread pain (WSP) or fibromyalgia syndrome (FMS). A secondary objective will be to determine the effect of milnacipran on pain and quality of life measurements. Fifty SLE male and female patients, 18 years and older, will be recruited for a 15-week study, in which patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo. Measurements of fatigue, pain, and HRQOL will be compared between the milnacipran and placebo groups at the screening visit, baseline visit, week number 6, and week number 14. Milnacipran has been shown to be an effective treatment for pain, fatigue and physical function in FMS patients. To date, no clinical trials have demonstrated efficacy for the treatment of fatigue in SLE patients with concomitant WSP or FMS. The investigators hypothesize, based on FMS studies, that the milnacipran treated patients will have less fatigue than those in the placebo group. In addition, compared to control arm, those treated with the study drug will have less pain and improved quality of life.