Effects of Diatermy in Patients With Fibromyalgia.

NCT ID: NCT06414369

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2024-07-01

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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

This group will receive eight sessions of 20 minutes, for four weeks, twice a week.

Group Type: EXPERIMENTAL

Diathermy

Intervention Type: OTHER

A DT equipment (CET 400 VA - RET 130 Watts - Winback, France), with a frequency of 500 kHz and intensity at 40% will be used. It will be applied utilizing a flat capacitive head 4 cm in diameter. It will be applied using longitudinal and transverse movements and a conductive cream for DT. DT will be used over the TP of the right and left trochanteric prominence. The settings will be calibrated so that patients fell no more than mild warmth during the treatment.

Control group

The treatment will be simulated during eight sessions of 20 minutes (machine will be off), for four weeks, twice a week.

Group Type: PLACEBO_COMPARATOR

Simulated Diathermy

Intervention Type: OTHER

This same intervention that has been given to the experimental group, will be simulated as placebo in the control group; the DT will not be activated during administration.

Interventions

Diathermy

A DT equipment (CET 400 VA - RET 130 Watts - Winback, France), with a frequency of 500 kHz and intensity at 40% will be used. It will be applied utilizing a flat capacitive head 4 cm in diameter. It will be applied using longitudinal and transverse movements and a conductive cream for DT. DT will be used over the TP of the right and left trochanteric prominence. The settings will be calibrated so that patients fell no more than mild warmth during the treatment.

Intervention Type: OTHER

Simulated Diathermy

This same intervention that has been given to the experimental group, will be simulated as placebo in the control group; the DT will not be activated during administration.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Camilo Jose Cela University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edurne Ú Docasar

Role: PRINCIPAL_INVESTIGATOR

University Camilo José Cela

Locations

University Camilo José Cela

Madrid, , Spain

Countries

Spain

Other Identifiers

CamiloJDF

Identifier Type: -

Identifier Source: org_study_id