None listed
Conditions
Brief summary
Fibromyalgia is one of the most important health problem in developed countries with a prevalence of 2,1% and health costs growing every year. Patients with fibromyalgia suffer pain all over the body and many other symptoms such as depression, headache, irritable colon, painful menstruation, irritability, thermal sensitivity, fatigue, joint stiffness and sleep disturbances. At the moment, fibromyalgia lacks of an effective treatment, among others things because there is no consensus about its etiology. Its approach consist on symptomatic treatment of pain and the associated symptoms by medication. The poor results of medication at relief pain at long time and the adverse effects as risk of dependence and tolerance of some drugs make necessary to find alternative safer and good quality treatments. Dielectric Monopolar Electromagnetic Signals treatment has been successfully tried to treat neuropathic pain and some types of chronic pain, presenting no adverse effects and with a reduce cost of maintenance, reasons that show it has an interesting alternative for fibromyalgia treatment. Hypothesis -Dielectric Monopolar Electromagnetic Signals (DMES) treatment will improve at short time the upper trapezius and the general pain of fibromyalgia patients. -DMES treatment will improve at short time the quality of life impact, the depression, the anxiety and the quality of sleep in fibromyalgia patients. -Standard treatment added to DMES treatment will be more effective than only the standard treatment of the patients. Objectives: -To check the efficacy at short time of DMES treatment in releasing upper trapezius and general pain in fibromyalgia patients. -To check the influence of DMES treatment on quality of life impact, depression, anxiety and quality of sleep in fibromyalgia patients. -To measured if DMES treatment added to the standard treatment of patients get bigger improvement in subjects variables than only the standard treatment of patients.
Interventions
There will be two study arms: Intervention and control.
-Intervention group will receive eight treatment sessions of 20 minutes of duration along two weeks (from Monday to Friday the first week and Monday, Wednesday and Friday the second week). In each of them, a Dielectric Monopolar Electromagnetic Signals Device will be used to treat the patient upper trapezius by massaging and heating (38 degrees Celsius) it with the device applicator, which will use a 30 volts and 800-900 kilohertz range em
There will be two study arms: Intervention and control. -Intervention group will receive eight treatment sessions of 20 minutes of duration along two weeks (from Monday to Friday the first week and Monday, Wednesday and Friday the second week). In each of them, a Dielectric Monopolar Electromagnetic Signals Device will be used to treat the patient upper trapezius by massaging and heating (38 degrees Celsius) it with the device applicator, which will use a 30 volts and 800-900 kilohertz range emission. The pressure used will be of 2kg in order to reach pressure enough without producing pain. The treatment will be held on a wood portable physiotherapy table, situated in a climatized room. The patients will be on the table in prone position all along the treatment. A physiotherapist with over 5 years of experience will deliver the treatment. In order to maintain adherence to the treatment, the physiotherapist who treat the intervention group will remember the patients to come to treatment by phoning them the day before.
Sponsors
Alfonso Javier Ibañez Vera
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women diagnosed of fibromyalgia by the ACR Criteria of 1990, in treatment for the fibromyalgia syndrome symptoms (pain, depression, fatigue...)
Exclusion criteria
-To have make any change in medication intake in the previous SIX months before the study begins or during it. -Being or have being under humoral treatment in last two years -To suffer alterations of thermal sensivity -To present any of the contraindications of the treatment device: be carriers of pacemakers, heart valves or any other implanted electrical or electronic device, be pregnant, have active or acute hemorrhagic areas, have open wounds or undiagnosed skin pathologies.
Outcome results
None listed