Effects of Diatermy in Patients With Fibromyalgia.

Fibromyalgia Clinical Trial

— FIBDIAT  

Official title:

Effects of Diatermy in Patients With Fibromyalgia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414369
• Other study ID #: CamiloJDF
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: Camilo Jose Cela University
• Contact: Edurne Ú Docasar
• Phone: +34918153131
• Email: eubeda[@]ucjc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Camilo Jose Cela University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.