Effects of Diatermy in Patients With Fibromyalgia.
- Conditions
- Fibromyalgia
- Interventions
- Other: DiathermyOther: Simulated Diathermy
- Registration Number
- NCT06414369
- Lead Sponsor
- Camilo Jose Cela University
- Brief Summary
Diathermy is a non-invasive pain therapy based on the local application of high-frequency electromagnetic waves. This procedure produces deep heat promotes tissue repair and influences pain sensitivity. The main characteristic of fibromyalgia (FM) is generalized musculoskeletal pain. This may be accompanied by muscle and joint stiffness, sleep and mood disorders, anxiety and depression, cognitive dysfunction, and chronic fatigue. Endemic in developed countries, with a higher prevalence among women than men, and the etiology is still unknown. Diagnosis is made on chronic generalized pain and through the presence of tender points. The objective of this study will be to analyze the efficacy of diathermy on pain in patients with fibromyalgia
- Detailed Description
The researchers aimed will be to observe the effect of diathermy (DT) on chronic fatigue, anxiety, and depression; analyze whether there are improvements in the impact of the disease in patients with FM after the application of DT; and check if there is an improvement in the quality of sleep after the application of DT.
The aim is to collect a sample of more than 30 patients with fibromyalgia. Variables to be collected include the overall pain experienced by the patients (Visual Analog Scale), Presure Pain Threshold using an algometer of the right and left trochanteric prominence, the Fibromyalgia Impact Questionnaire (FIQ) measures the impact of FM, the Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression, the Pittsburgh Sleep Quality Questionnaire (PSQI) to measure sleep quality and the modified Fatigue Impact Scale (MFI-S) to measure self-reported general fatigue.
Subjects will be randomized into two groups: a control group (CG) that will not recive treatment and a experimental group (EU).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Experience chronic generalized pain and be diagnosed with FM for at least three months
- Recent surgery, skin conditions unsuitable for DT application, presence of certain neuropathic conditions (lupus, rheumatoid arthritis, diabetic polyneuropathy), ongoing pharmacological treatment such as anticoagulants within three days before participation, any underlying medical conditions like fractures or tumors; cardiac pathologies including heart failure, uncontrolled arterial hypertension, arrhythmias, phlebitis thrombi arteriopathies; having a pacemaker or suffering from epilepsy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Diathermy This group will receive eight sessions of 20 minutes, for four weeks, twice a week. Control group Simulated Diathermy The treatment will be simulated during eight sessions of 20 minutes (machine will be off), for four weeks, twice a week.
- Primary Outcome Measures
Name Time Method Pain (VAS) base line; after finish the treatment (4 weeks) and 15 days after completing treatment. visal analogue scale, on a scale of 1-10, with higher scores indicating more pain.
Pain (algometry) base line; after finish the treatment (4 weeks) and 15 days after completing treatment. Algometer, on a scale of 0-5. with higher scores indicating less pain.
- Secondary Outcome Measures
Name Time Method The impact of fibromyalgia. base line; after finish the treatment (4 weeks) and 15 days after completing treatment. The Fibromyalgia Impact Questionnaire (FIQ) measures the impact of FM. The values range between 0 and 100, with a higher score indicating a greater impact of the disease.
anxiety and depression base line; after finish the treatment (4 weeks) and 15 days after completing treatment. The Hospital Anxiety and Depression Scale (HADS) questionnaire, that consists of 14 items, divided into two subscales with 7 items each, using a Likert scale from 0 to 3. The odd-numbered items pertain to HADA, and the even-numbered ones relate to HADD. Each scale has a score range of 0-21 points. Higher scores indicate higher levels of anxiety and depression. Scores exceding 11 are classified as "cases," while those surpassing 8 are regarded as "probable cases" of anxiety and depression
sleep quality base line; after finish the treatment (4 weeks) and 15 days after completing treatment. The Pittsburgh Sleep Quality Questionnaire (PSQI)assesses seven dimensions: sleep quality, delay in falling asleep, duration of sleep, perceived effectiveness of sleep, disturbances during sleep, use of medication for sleeping, and daytime dysfunction. Each aspect is assigned a score from 0 to 3. Lower scores indicate no challenges in the specific areas while higher scores up to 3 indicate severe difficulties. The maximum achievable total score is 21 denoting critical sleep issues. A higher point total corresponds to a greater severity of sleep disorders.
self-reported general fatigue base line; after finish the treatment (4 weeks) and 15 days after completing treatment. The modified Fatigue Impact Scale (MFI-S) with a a higher score that indicates a more severe condition.
Trial Locations
- Locations (1)
University Camilo José Cela
🇪🇸Madrid, Spain