Effects of Diatermy in Patients With Fibromyalgia. (FIBDIAT)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Diathermy; Other: Simulated Diathermy

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edurne Ú Docasar; Phone Number: +34918153131; Email: eubeda@ucjc.edu
• Study Contact Backup: Name: Edurne Ú Docasar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; This group will receive eight sessions of 20 minutes, for four weeks, twice a week.	Other: 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.
Placebo Comparator: Control group; The treatment will be simulated during eight sessions of 20 minutes (machine will be off), for four weeks, twice a week.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (VAS)	visal analogue scale, on a scale of 1-10, with higher scores indicating more pain.	base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
Pain (algometry)	Algometer, on a scale of 0-5. with higher scores indicating less pain.	base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of fibromyalgia.	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.	base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
anxiety and depression	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	base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
sleep quality	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.	base line; after finish the treatment (4 weeks) and 15 days after completing treatment.
self-reported general fatigue	The modified Fatigue Impact Scale (MFI-S) with a a higher score that indicates a more severe condition.	base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University
• Investigators: Principal Investigator: Edurne Ú Docasar, University Camilo José Cela

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pain; quality of life; fibromyalgia; anxiety; diathermy; chronic fatigue
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CamiloJDF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No