Active clinical trials for "Fibromyalgia"

The purpose of this study is to determine if addition of Transcutaneous Electrical Nerve Stimulation (TENS) to routine physical therapy improves movement-evoked pain in patients with fibromyalgia (FM). The study will also determine if addition of TENS to routine physical therapy (PT) improves disease activity and symptoms, increases adherence to physical therapy, increases the likelihood of meeting patient specific functional goals, and reduces medication use.

The aim of this study is to compare the developed home-based surface electrical stimulation program to the controls in computer office workers with MPS.

Sonodyn is an investigational device that within this clinical investigation is intended for use in patients suffering from low back pain, tension headache or neck pain, originating from therapy-resistant myofascial pain syndrome. Myofascial pain syndrome is a prevalent pain condition in the adult population and a common cause of pain and dysfunction in the musculoskeletal system. It is a trigger point-induced regional musculoskeletal pain disorder affecting one or more muscles or groups of muscles. Sonodyn is a handheld medical device that combines low-energy ultrasound, electrical and magnetic field stimulation for non-invasive transcutaneous treatment of chronic myofascial pain syndrome. Sonodyn is a battery-operated, rechargeable stimulation device to be placed over specific trigger points for associated pain patterns in the human body. It emits ultrasound, electrical and magnetic stimulation signals with a pre-defined set of parameters for each of the independently operated power sources. The study will follow a prospective, randomized, sham-controlled, double-blind parallel group design. It will be conducted as a multi-center investigation at 6 sites in Austria and Switzerland. Patients are randomized in a 2:1 ratio into Treatment and Control. Active Sonodyn therapy (Treatment) No therapy (Sham Control) Two types of Sonodyn devices will be used: a fully functional one for Therapy arm patients that can deliver stimulation, and a non-functional one for Control arm patients that cannot convey any energy signals to the device output. The devices will look fully identical. Randomization will be stratified by study site, pain diagnosis and sex of the patient. For each subject, after a screening phase of 1 week, patients will be treated for 3 weeks with a follow-up of additional 8 weeks, adding up to 12 weeks. During treatment patients will activate their device 3 times a day for 10 minutes each. During screening, treatment and follow-up period, all patients will twice per day report the average and maximum intensity of their pain Numeric Rating Scale (NRS). Patients will also enter the date, amount, and time of intake of rescue medication, if applicable. The primary objective of this study is to assess the impact on pain. Secondary objectives are to compare the performance between active therapy and sham, as well as to correlate changes in pain intensity with other pain related scales.

To determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.

The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.

The aim of the study is to demonstrate a significant improvement in quality of life specific to patients with fibromyalgia syndrome in patients with fibromyalgia syndrome with comorbid posttraumatic stress disorder, treated with reconsolidation blockade. Patients receive a treatment with propranolol associated with reconsolidation blockade of traumatic story once a week during 6 weeks, with evaluation at inclusion and at 3 months.

This is a parallel-group randomised clinical trial: Primary purpose: To analyse the clinical changes produced by two different physiotherapy treatments (Intratissue Percutaneous Electrolysis and Dry Needling) for myofascial trigger points in the infraspinatus muscle in subjects with non-specific shoulder pain. Hypothesis: A physiotherapy treatment including Intratissue Percutaneous Electrolysis therapy present greater benefits in terms of pain reduction and increased mobility and functionality rather than Dry Needling treatment in subjects with non-specific shoulder pain. The intervention consisted of 3 treatment sessions, different according to the group, once a week. Seven evaluation points were performed, two pre-intervention evaluations one week apart and after the second one the first treatment session was performed. The third and fourth assessments were prior to the second and third treatment sessions, one week apart. The fifth, sixth and seventh assessments were conducted one week, one month and two months after the last treatment session in each group.

Arthritis is a common condition in the United States, and a leading cause of pain and disability. Physical exercise is recommended for managing arthritis, but access to evidence-based exercise programs is limited, particularly in rural areas. Therefore, the investigators propose to evaluate remote delivery of an evidence-based exercise program called Enhance Fitness (EF) that is recommended for arthritis management. The primary purpose of this study is to determine if remotely delivered EF is non-inferior to in-person EF on primary and secondary outcomes.

Treatment options for chronic non-oncologic musculoskeletal pain are varied and include both pharmacological and non-pharmacological interventions, such as physical activity and psychotherapy. In clinical practice, the prevalent approach is pharmacological, based mainly on the use of pain modulators, such as antidepressants, cannabinoids and anti-epileptics, and on the use of traditional painkillers such as NSAIDs and opioids. In particular, the latter are still widely prescribed in clinical practice. Initially very effective in combating fibromyalgia pain, opioids, when taken chronically, lead to the development of tolerance with the need for the patient to gradually increase the dosage or switch to more powerful active drugs to obtain the same effect. In the face of fleeting and limited benefits, the risk, therefore, is that of falling back into a framework of abuse with consequent negative impact on both health and social status. In this context, the non-pharmacological approach plays a role of primary importance. In particular, exercise is currently recommended as one of the most effective management strategies. However, the implementation of exercise as a treatment for chronic pain is significantly hampered by poor patient compliance. Another non-pharmacological strategy is biofeedback (BF); however, although existing data support the use of BF, in clinical practice the results obtained have not supported expectations. A solution to these limitations could come from virtual reality (VR), an innovative method capable of simulating real-world situations and cognitive and motor tasks in a safe and stimulating environment, making the completion of activities rewarding and benefiting all those patients who need motor rehabilitation or musculoskeletal pain management. This is a single-center interventional randomized device-controlled study, with two study arms: The treatment group: subjected to 5 days of VR experience and subsequently monitored using questionnaires until the 15th day after the end of the experience. The control group: initially placed on hold and subsequently also subjected to 5 days of VR experience only when the treatment group has finished its shift; subsequently each patient will be monitored until the 15th day after the end of the experience. Primary endpoint: - Demonstration of a pain reduction of at least 30% according to the VAS scale (0-100) in patients undergoing VR compared to those not undergoing VR. Inclusion criteria - Patients aged 30-50 years who complain of chronic musculoskeletal pain lasting at least three months, without diagnosis of inflammatory causes Exclusion criteria Concomitant diagnosis of major psychiatric pathologies with the exception of anxiety-depressive disorder; Concomitant diagnosis of neurological pathologies; Concomitant diagnosis of inflammatory rheumatological diseases that may cause chronic pain. Statistical analysis On the basis of the primary endpoints set, it is planned to enroll a sample of 20 patients, 10 per treatment group, considering an alpha error of 0.05 and a power of 80%. Considering a dropout of approximately 2 patients, a final sample of 24 patients is considered, 12 for each group. Comparisons between the two groups of patients will be performed using parametric or non-parametric statistical tests, based on the distribution of the variables, using the Student or Mann-Whitney t test for continuous variables, and Chi-square or Fischer, for variable dichotomous or ordinal. Any correlations will be determined through the calculation of the Odds Ratio.

This study evaluates whether differences exist between adolescent females with juvenile-onset fibromyalgia and healthy controls in processing of pain and emotion at the neural level as assessed by functional magnetic resonance imaging (fMRI). The study includes a longitudinal component to evaluate changes in neural processing of pain and emotion before and after different treatment strategies.