View clinical trials related to Somatoform Disorders.
Filter by:Patellofemoral Pain Syndrome (PFPS) is characterized by diffuse pain around the knee joint. This presence of pain is the most common manifestation in sports medicine among adults and young people. Women are more likely to develop PFPS. Among the young adult population, it is estimated that 13% of the women are affected by PFPS. There is a consensus among clinicians that PFPS etiology is multifactorial, including local factors (structures present or acting directly on the patellofemoral joint) and nonlocal factors [extrinsic to the patellofemoral joint, including proximal factors (hip, trunk and pelvis), and distal factors (ankle and foot)]. PFPS is not a degenerative syndrome, and conservative treatment offers good results. However, the most appropriate therapeutic approach is still unclear, and the rate of nonresponders to treatment is high. One of the possible explanations for failure of the therapeutic intervention is that the triggering mechanisms of PFPS are not the same for all subjects, and probably some patients cannot be reached by standard treatment. The traditional intervention model focuses on the strengthening of the knee extensor muscles, but recent literature has pointed out that multi-articular treatment models (i.e., exercises for the proximal or distal factors, in addition to exercises for the quadriceps) have shown better results. It is believed that the elaboration of treatment protocols combining local and non-local factors, present greater responsiveness and results retention, thus reducing treatment failure. Based on this, and due to the lack of experimental studies that aimed to compare the effects of a multi-articular intervention protocol combining local and non-local factors in women affected by PFPS, this study aims to evaluate the effects of two multi-articular intervention protocols based on exercises (1) for the proximal and local factors versus (2) for the distal and local factors on the clinical, functional and neuromechanical outcomes of young women with PFPS. Participants of the PFPS group will be submitted to one of two intervention models for an 12-week rehabilitation program. Model 1 will be composed of exercises focusing on local and proximal PFPS factors, and Model 2 will be composed of exercises focused on the local and distal factors.
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.
Background: Physiotherapists (PTs) in primary health care manage patients with a large variation in medical diagnosis, age, functional status, disability and prognosis. Lack of knowledge and systematically collected data about patients treated by PTs in primary health care has prompted this longitudinal observational physiotherapy project in Norway. This paper aims to describe a method for developing a database of patients managed by PTs in primary health care to study patients' characteristics, treatment courses and prognostic factors. The study is a longitudinal observational project, following patients through physiotherapy treatment periods in primary health care in Norway and until one year after inclusion. The project involves both private practice and municipally employed PTs working in primary health care in eight municipalities in Norway. The participants are recruited to three different parts of the project depending on age and whether they are referred to a private practice or a municipally employed PT. All data are recorded electronically, transferred and stored securely. All patients complete extensive questionnaires providing information about demographics, disability and function, pain related variables, treatment and evaluation of treatment as well as clinical tests. The PTs have access to their own patients' data. The investigators have also prepared for linkage to national patient registers and population-based studies to be able to gather further important data. This project will have important implications for physiotherapy services in primary health care. The database already contains almost 3000 patients, and data collection is ongoing. Preliminary analyses suggest that the patients included so far are representative of the larger population of patients treated by private practice or municipally employed PTs in Norway. This large scale prospective physiotherapy project will provide knowledge about the patient groups treated, treatment given as well as short and long term outcome of the patients.
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.
The objective of this prospective, observational study is to determine the association between the composition of the gut microbiota and the severity and persistence of Complex Regional Pain Syndrome symptoms (Study A). The objective of Study B, a longitudinal study of microbiota biomarkers of patients with newly diagnosed CRPS is to determine if the researchers can predict which patients are more likely to recover compared to those who do not. A secondary objective of both studies is to examine cognitive flexibility in relation to outcomes (study A and B).
The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS). The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid 100 mg or placebo) over 10 days, and a Follow-up Period 1 until Week 26. At Week 26, participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52. Participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52.
About 70-80% of patients with somatic symptom disorder (SSD) visit the general medical hospital instead of psychiatric or other mental health settings. The current self-reporting questionnaires are neither sufficiently considering companioned anxiety or depression nor validated for monitor the treatment efficacy of such group. The Somatic Symptom Scale-China (SSS-CN) is developed due to the urging clinical demanding in general hospital. The study aims to investigate whether the SSS-CN could serve as a timely and practical instrument to detect SSD and assess the severity of the disorder.
This is a randomized, multi-center, double-blind, parallel-group study, enrolling approximately 100 male subjects diagnosed with CP/CPPS to evaluate the effect of 12-week treatment with AQX-1125 (active drug) compared to placebo. The subjects will be randomized to receive orally once-daily either AQX-1125 (200 mg) or placebo in a 1:1 ratio across approximately 30 centers in North America (United States and Canada). The study will consist of a screening period of up to 3 weeks, a 12-week treatment period followed by a 4-week off drug safety follow-up period, and an ophthalmic safety follow-up call at 3 months and visit at 6 months post last dose, for a total study duration of about 41 weeks.
Greater Trochanteric Pain Syndrome (GTPS), also known as Trochanteric Bursitis, is a painful condition predominantly affecting middle aged women. It is characterised by pain in the lateral hip exacerbated by movement and lying on the affected side. GTPS encompasses different conditions including gluteus medius/minimus tendinopathy and bursal inflammation. The treatment for this condition begins with conservative treatments of analgesia and physiotherapy, which normally results in a resolution of symptoms. If this fails then steroid injections have been shown to be effective. If this is not successful patients are offered surgery. Steroid injections however may only be effective in the short term and sometimes patients require repeat injections. Platelet rich plasma (PRP) is plasma taken from the blood of the patient that has been treated so that it has a higher than usual concentration of platelets in it. It has been postulated to promote healing in damaged or inflamed tissues. Platelets contain a variety of growth factors, which are involved in healing. It has been used in a variety of orthopaedic conditions such as lateral elbow epicondylitis, patellar tendonitis, rotator cuff pathology and planter fasciitis. Studies have shown varying effects of PRP in these conditions with most promise in plantar fasciitis and patellar tendonitis. These conditions are similar to GTPS. A recent review of treatments for GTPS concluded that more research into PRP efficacy in GTPS is required. We hypothesise that PRP is effective in treating GTPS in patients who have not responded to conservative management (analgesia and physiotherapy). This is an area that lacks research and could be valuable to those suffering from GTPS. Further study is required as PRP could be used as instead of steroid injections or if steroid treatments have failed and this could prevent patients from suffering further or needing surgery. The investigators propose a randomised control trial comparing a normal saline injection with a PRP injection in patients with GTPS, diagnosed by MRI scan, who have not responded to conservative treatments. Patients will receive either PRP or normal saline under ultrasound guidance by a consultant rheumatologist. Sample size calculation has shown that the investigators will need to recruit a total of 100 patients who will be randomised into either arm (50 in each arm). The recruitment period will last 2 years with the whole trial aiming to finish in 4 years from the proposed start date. Neither patients or the study team members assessing the outcomes will know which treatment the patient received. Patients will be followed up at 3, 6 and 12 months. The primary outcome measure will be a patient reported outcome measure (PROM) i-HOT12 (international hip outcome tool) which is a valid and reliable scoring system that assesses patient's ability to return to an active lifestyle through obtaining subjective measures of symptoms, as well as determining emotional and social health status. This will be alongside secondary outcome measures Visual Analogue Pain Score, Modified Harris Hip Score and EQ-5D collected. The proposal was discussed with a group of patients who previously had treatment with Platelet Rich Plasma (PRP) injection for hip pain. A discussion was had with regards the setup of a study and they were enthusiastic about this. A patient information sheet was shown to them and modified as per their comments. Their advice was obtained with regards the setup of this study, the randomisation into placebo arm, followup frequency and the outcome measures. In particular, patients suggested that if placebo was not working then a switch over to treatment arm should be discussed sooner than the initially planned one year. This has been taken into account and six month has been agreed. The proposal was also discussed in the NRES committee who are satisfied with the proposal. Ethical approval has been granted and the study is registered with Health Research Authority England.
The study purpose is to investigate the effectiveness of a program combining biomechanical taping with lower extremity neuromuscular exercises for runners with patellofemoral pain syndrome (PFPS) and hallux valgus