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Completed

NCT Number: NCT06414369

Effects of Diatermy in Patients With Fibromyalgia.

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

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Key information

Conditions

Fibromyalgia Anxiety Disorders Body Temperature Changes Fever Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Camilo José Cela

Madrid, 28692, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diathermy

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.

Simulated Diathermy

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.

Primary outcomes

  1. Pain (VAS)

    Time frame: 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.

  2. Pain (algometry)

    Time frame: 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 outcomes

  1. The impact of fibromyalgia.

    Time frame: 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.

  2. anxiety and depression

    Time frame: 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

  3. sleep quality

    Time frame: 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.

  4. self-reported general fatigue

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Acronym: FIBDIAT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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