Clinical trial NCT06414369: Effects of Diatermy in Patients With Fibromyalgia.
Official title: Effects of Diatermy in Patients With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
diathermy
pain
quality of life
chronic fatigue
anxiety
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Experience chronic generalized pain and be diagnosed with FM for at least three months

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain (VAS)
timeFrame: base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
measure: Pain (algometry)
timeFrame: base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
Secondary outcomes:
measure: The impact of fibromyalgia.
timeFrame: base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
measure: anxiety and depression
timeFrame: base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
measure: sleep quality
timeFrame: base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
measure: self-reported general fatigue
timeFrame: base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Camilo José Cela
Study officials:
affiliation: University Camilo José Cela
name: Edurne Ú Docasar
role: PRINCIPAL_INVESTIGATOR
References: