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Somatoform Disorders clinical trials

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NCT ID: NCT03479190 Completed - Clinical trials for Greater Trochanteric Pain Syndrome

Platelet Rich Plasma Versus Placebo for the Treatment of Greater Trochanteric Pain Syndrome (HiPPO Trial)

Start date: September 3, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03445403 Completed - Clinical trials for Chronic Pain Syndrome

Offset Analgesia as a Measure of Central Sensitization in Children

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Pediatric chronic pain disorders are common and consequential in Western societies, occurring in 25-80% of population-based samples with a median prevalence of 11-38% and significant pain-related disability in 3-5% of these children. Pediatric chronic pain disorders have a negative impact on many aspects children's lives including mobility, night sleep, school attendance, peer relationships, family functioning, and overall quality of life. Parents caring for these children risk loss of parental earnings, and these disorders place a high financial burden on healthcare. In a nationally representative sample in the United States, costs related to health care were significantly higher ($1,339 per capita) for children with chronic pain disorders compared to children with common pediatric health conditions of ADHD, asthma and obesity. In children with clinical chronic pain conditions, such as daily headaches or fibromyalgia, chronic pain is presumably a persistent state of an overly excitable nervous system. This phenomenon known as central sensitization is characterized by excessive pain sensitivity that occurs in response to non-painful stimuli, such as light touch or contact with clothing, and slightly painful stimuli, such as a light pinprick. This hypersensitivity results from peculiar changes in the working of the central nervous system, including the spinal cord and brain, and leads to unusual intensification of pain that is out of proportion to the inciting stimulus. For example, light touch from clothing on the skin is perceived as intensely painful. Central sensitization is also thought to contribute to the spreading of pain to other body sites in several chronic pain disorders. In chronic pain disorders, the function of the central descending inhibitory modulating system is likely impaired and is traditionally measured by a phenomenon identified as "conditioned pain modulation (CPM)" and more recently measured by a phenomenon of "offset analgesia" (OA). The OA test is more robust than the CPM test and likely more acceptable to most patients, especially children, because it is shorter in duration and uses a more tolerable painful stimulus. Compared to CPM, the OA test is more tolerable because it is conducted using a painful test stimulus that is less than the maximal (suprathreshold). Additionally, the time of exposure to the painful stimulus is significantly shorter, a few seconds, in the OA test compared to CPM. The central descending inhibitory pathway that modulates pain as tested by OA is functional and mature in healthy children as young as 6 year of age, but it has yet to be investigated in children with chronic pain disorders. The investigators plan to test OA responses in a population of common pediatric pain disorders with overlapping symptomology attributed to central sensitization (such as chronic musculoskeletal pain, chronic abdominal pain and chronic headaches and chronic regional pain syndromes) and compare their responses with an age- and sex-matched control group. The characteristics of OA responses in each group will allow for assessment of the presence or absence of central sensitization as a mechanism driving the persistent, abnormal pain in a subgroup of these chronic pain disorders. The investigators hypothesize that central sensitization is the potential contributory mechanism of the central nervous system heightened sensitivity to two testing stimuli of painful (moderate heat discomfort sensation) and non-painful (warmth sensation) in children with chronic pain disorders. These types of sensations mimic those that children would be expected to experience their natural environment during typical activities of daily living such as showering/bathing in warm water or hand washing. Additionally, the Pain Sensitivity Questionnaire (PSQ) and Central Sensitization Inventory (CSI) will be used as clinical screening tools for subjective report of sensitization symptoms, and are simple and easy to administer in a clinical setting. The investigators hypothesize that these measures will correlate with the objective offset analgesia responses thus allowing for assessment of central sensitization in children with chronic pain disorders. These tests are advantageous because they are feasible to perform rapidly in a clinic setting and have utility for measurement of patient responses to therapeutic interventions. If this concept is supported by this study, future studies could utilize OA to examine the effects of various pharmacological and physical interventions used to manage children with chronic pain disorders including intensive interdisciplinary rehabilitation or specific interventions such as aerobic exercise, which likely modulates pain via similar mechanisms.

NCT ID: NCT03436459 Completed - Clinical trials for Myofascial Pain Syndrome

Effects of Extracorporeal Shock Wave Therapy and Low Level Laser Therapy in Myofascial Pain Syndrome

Start date: February 2016
Phase: N/A
Study type: Interventional

This study evaluates the effects of low level laser therapy and extracorporeal shock wave therapy in patients with myofascial pain syndrome of the upper trapezius. Half of the patients receive laser therapy, half of them receive shock wave therapy for three weeks.

NCT ID: NCT03377504 Completed - Clinical trials for Complex Regional Pain Syndrome Type I

Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

CRPS Type 1 can occur after traumas, surgical applications or central nervous system disorders. The triggering factor in CRPS type 1 is fracture in about half of the cases. Mirror therapy is an innovative treatment approach that is cheap, easy to administer and non-invasive. It is thought that this treatment may be complementary to other rehabilitation methods.Neurophysiologic effects of mirror therapy are noted in the brain, especially in the parietal region, cerebellum, basal ganglia and premotor cortex. Mirror therapy is also effective through the mirror neuron system. Mirror therapy triggers neuroplasticity by increasing the connection between neurons in the brain and thereby enhances communication between the motor and the sensory cortex. Recent studies have shown the positive effects of mirror therapy in patients with CRPS Type 1 disease. There are two randomized controlled trials showing the efficacy of mirror therapy in patients with CRPS Type 1 after stroke. Only one pilot study was performed in patients with CRPS Type 1 who were traumatic origin. There are no randomized controlled trials investigating the efficacy of mirror therapy in CRPS Type 1 patients who developed secondary to trauma in the literature. The purpose of this study is to investigate the clinical effects of mirror therapy applied in addition to routine rehabilitation program in patients with traumatic CRPS Type 1. The investigators hypothesized that adjunctive mirror therapy to classical rehabilitation program would result in better outcomes compared with the classical program only.

NCT ID: NCT03376269 Completed - Fibromyalgia Clinical Trials

HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma

HBOTCSA
Start date: December 2014
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury.

NCT ID: NCT03338465 Completed - Mobility Limitation Clinical Trials

Extracorporeal Shockwave Treatment for Greater Trochanteric Pain Syndrome

ESTATE
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Greater trochanteric pain syndrome (GTPS) is characterized by pain over the greater trochanter, which can refer down the lateral aspect of the hip. Historically, conservative treatments such as rest/activity modification, anti-inflammatory medication, physiotherapy and local corticosteroid injection, are employed as first-line management, with some refractory cases requiring surgical intervention. Acknowledging the unpredictable response and frequent recurrences associated with traditional non operative treatment, the risks and prolonged rehabilitation associated with surgery, and the favorable results from prior studies involving radial pressure waves as a treatment for GTPS, the aim of this study is to investigate the dose-related effect of focalized shockwave treatment at different total energy influx in patients with chronic GTPS.

NCT ID: NCT03338283 Completed - Clinical trials for Subacromial Pain Syndrome

Electro-massage in Subjects With Subacromial Pain Syndrome

Start date: December 15, 2017
Phase: N/A
Study type: Interventional

Objectives: Establishing and validating an electrotherapy procedure with interferential current (IFC) application using electro-massage on patients who have undergone acromioplasty surgery. To evaluate the possible decrease in pain perception and improvement of functionality following surgical intervention. Design: Randomized, single blind clinical trial. Subjects: 18-patients, aged 18 to 65, with a similar distribution of male and female participants Methods: 10-patients will be enrolled in the experimental group and 8 patients as the control group. Both groups of patients will undergo six physiotherapy sessions (three times a week). The experimental group will undergo a treatment consisting of electro-massage with constant voltage (CV) IFC bipolar application, 4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes will be used. Session length with electrotherapy will be approximately ten minutes.

NCT ID: NCT03317808 Completed - Clinical trials for Subacromial Pain Syndrome

Exercise for Subacromial Pain Syndrome

Start date: October 16, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in comparison with traditional supervised exercise as treatment for patients with subacromial shoulder pain. The purpose is to evaluate if HSR is feasible fir these patients, and compare its effect to traditional exercise at pain and function of the shoulder. One half will complete the heavy slow resistance exercise, the other will complete the conventional exercise.

NCT ID: NCT03293940 Completed - Clinical trials for Post-Mastectomy Chronic Pain Syndrome (Disorder)

Cryoablation for Post Mastectomy Pain Syndrome

Start date: January 10, 2018
Phase: N/A
Study type: Interventional

This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.

NCT ID: NCT03286881 Completed - Depression Clinical Trials

Brief Evidence-based Psychological Treatments for Emotional Disorders

PsycBrief
Start date: January 15, 2017
Phase: N/A
Study type: Interventional

The present work aims to develop a randomized clinical trial with a sample of 165 patients diagnosed with an emotional disorder. All participants are tested by several self-reports related to common mental disorders in a repeated measures design, pre and post treatment as well as a six month follow up. We think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life while simultaneously reducing costs.