Active clinical trials for "Somatoform Disorders"

ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessment regarding the therapeutic effects of acupuncture. Methods: Sixty patients with CP/CPPS will be randomly assigned to receive either acupuncture or sham-acupuncture (30 patients, each). Treatment will be conducted 3 times/week, for 4 weeks. The primary outcomes will each be the change from baseline of the total NIH (National Institutes of Health) CPSI (Chronic Prostatitis Symptom Index) score associated with 3 modes of assessment: Mode 1, the scale recorded at the hospital within 10minutes after the last session of 4 weeks of acupuncture treatment, in the company of the outcome assessors; Mode 2, the scale recorded the same day, but not at the hospital; and Mode 3, the scale recorded at the hospital 1 to 3 days after the last acupuncture session. The 3 key secondary outcomes include will be the 3 modes assessment of the changes from baseline of the NIH-CPSI total scores in the acupuncture group at week 4 after treatment. Analysis was by intention-to-treat, and multiplicity was controlled for with a step-down closed-testing procedure.

Patients with myofascial pain syndrome at upper trapezius will be randomized into 2 groups, fascial injection group and subcutaneous control injection group. Pain condition pain, range of motion and function will be evaluated in 1 week, 4 weeks and 12 weeks after injection.

To investigate the efficacy and safety according to the frequency of focused ESWT in patients with myofascial pain syndrome.

This single-center, randomized, controlled, quadruple-blinded, superiority trial is performed to test the hypothesis that children with IBS and FAP-NOS who receive a low-FODMAP diet will have a lower mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.

To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of zoledronic acid in managing pain in Complex Regional Pain Syndrome patients.

This study will try to learn more about complex regional pain syndrome, or CRPS (previously known as reflex sympathetic dystrophy, spreading neuralgia, and sympathalgia), by examining the release of small proteins in the blood of patients with this condition. Patients with CRPS usually have three types of symptoms: Sensory abnormalities increased sensitivity to pain or a painful reaction to a harmless stimulus Perfusion abnormalities alterations in blood flow, temperature abnormality, swelling, decrease or increased nail growth, and hair and skin changes Motor abnormalities weakness, guarding (Holding the limb in such a fashion that it minimizes accidental or intentional contact from possible sources of pain), and atrophy (wasting) The cause of CRPS is unknown, and there are no definitive diagnostic tests for the condition. Because early treatment improves the prognosis of CRPS, a test that enables early diagnosis would be important for optimal medical management. The findings of this study may contribute to the development of such a test and possibly new drug treatments. Normal healthy volunteers and patients of any age with complex regional pain syndrome who are in otherwise good general health may be eligible for this study. Participants will have a medical history, physical examination and collection of a blood sample. They will fill out several questionnaires, providing information on their health, personality, mood, pain levels, and symptoms. Participation in the study requires one outpatient clinic visit.

Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back, accounts for approximately 2.63 million visits in the United States, or 2.3 percent of annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is lost from LBP. Approximately one-third of this is direct costs. Previous studies have established the safety of trigger point injections (TPI). However, the results of these studies are highly heterogeneous regarding TPI's ability to treat pain or improve functional outcomes. The two most promising TPI studies conducted in the ED have been published in the last two years. They both suffered from a small sample size. Additionally, they suffered from a combination of limitations including: lack of randomization, inconsistent medical management, lack of a follow-up assessment, and lack of patient centered functional outcomes. These studies were both two armed and either compared standard medical management to TPI with local anesthetic or TPI with local anesthetic to TPI with Normal Saline (NS). One of these studies concluded that TPI is generally beneficial. The other concluded that TPI with NS is superior. Research Hypothesis: The investigators hypothesize that standard therapy (ST) plus TPI with 8 mL of 0.5 percent Bupivacaine is superior to ST alone or ST plus TPI with 8 mL of NS for the treatment of the pain associated with MPS of the low back. Significance: This will be the first TPI study to compare ST, to TPI with local anesthetic, and TPI with NS for LBP conducted in an ED. It will also be the first TPI study to incorporate a patient centered functional outcome and patient follow-up after discharge from an ED. TPI's are a popular treatment modality for LBP among many Emergency Medicine Providers. However, to date, there is limited evidence for or against it. The investigators are hopeful that this study will answer whether or not trigger point injections are benefiting patients and, if so, which type of TPI is most beneficial.

Interstitial Cystitis / bladder pain syndrome (CI / BPS) is a debilitating pathology with a negative impact on the quality of life of affected individuals. It is characterized as the sensation of pain or discomfort related to the urinary bladder, accompanied by symptoms of the lower urinary tract, in the absence of infection. Among the phenotypes are Cystitis with Hunner's ulcer, essentially inflammatory pathology and without Hunner's lesion, non-inflammatory frequently associated with somatoform systemic changes. Functional changes in urothelium and epithelial barrier, neurogenic inflammation and autoimmune mechanisms are involved in the development of the disease. Medical ozone has anti-inflammatory, antioxidant, cytoprotective, antimicrobial and immunomodulatory properties. When administered, it is dissolved in biological fluids, immediately reacting with glycoproteins composed of carbohydrates and polypeptide chains. This reaction results in the formation of hydrogen peroxide (H2O2), lipid oxidation products (LOS), increased activation of erythroid-related nuclear transcription factors (Nrf2) activation of antioxidant response transcription elements (ARE) and increased variety of antioxidant enzymes that act as free radical scavengers. Benefits of O3 have been demonstrated in the treatment of neuropathic pain and hyperalgesia associated with the analgesic and anti-inflammatory effect. The objective of this work is to evaluate the effect of intravesical ozone gas administration in patients with Interstitial Cystitis / Painful Bladder Syndrome with low response to conventional therapy.

Objective: The primary aim is to evaluate the efficacy of botulinum toxin A in reducing overall limb pain in patients with complex regional pain syndrome (CRPS). Additionally the investigators would like to see if quality of life is improved and disability scores decreased. Research Design: This is a double blinded, randomized cross-over study that will be conducted over a 7 month period. It is a pilot study that will include twenty subjects recruited from the Neurology CRPS clinic at VA Connecticut and from outside VA hospitals within a 150 mile radius. Subjects will receive an intramuscular injection Treatment A which is only 1% lidocaine or Treatment B which is mixture of botulinum toxin A + 1% lidocaine in the affected limb only. This is a cross over study where patients will receive Treatment A or B initially during the first of four study visits and during the third study visit while receive whichever treatment not given during the first visit. Dr. Sameer Ali, VA neurology fellow, will be blinded when administering the treatments. Dr. Hajime Tokuno, VA neurologist who is the principal investigator of the trial will prepare the treatments. Clinical pharmacy will be randomizing the treatments. Dr. Tokuno will not be blinded as he needs to know which treatment has been given in case of complications. Impact/Significance: The significance of this study is the possible discovery of a new, safer, less invasive, and more efficacious therapeutic option for patients suffering from CRPS. Currently medical management with neuropathic pain meds, interventions such as sympathetic nerve blocks and ketamine infusion has helped some patients and not others. The investigators are trying to see whether either of the two treatments and especially the treatment with botulinum toxin may be a more viable alternative than existing modalities.