## Protocol Section
### Identification Module
**NCT ID:** NCT06414369

**Acronym:** FIBDIAT

**Brief Title:** Effects of Diatermy in Patients With Fibromyalgia.

**Official Title:** Effects of Diatermy in Patients With Fibromyalgia.

#### Organization Study ID Info
**ID:** CamiloJDF
#### Organization
**Class:** OTHER
**Full Name:** Camilo Jose Cela University
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Camilo Jose Cela University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Fibromyalgia

**Keywords:**

- fibromyalgia

- diathermy

- pain

- quality of life

- chronic fatigue

- anxiety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Diathermy

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Simulated Diathermy

**Label:** Control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** 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.

**Name:** Diathermy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** 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.

**Name:** Simulated Diathermy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** visal analogue scale, on a scale of 1-10, with higher scores indicating more pain.

**Measure:** Pain (VAS)

**Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

**Description:** Algometer, on a scale of 0-5. with higher scores indicating less pain.

**Measure:** Pain (algometry)

**Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

#### Secondary Outcomes

**Description:** 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.

**Measure:** The impact of fibromyalgia.

**Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

**Description:** 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

**Measure:** anxiety and depression

**Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

**Description:** 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.

**Measure:** sleep quality

**Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

**Description:** The modified Fatigue Impact Scale (MFI-S) with a a higher score that indicates a more severe condition.

**Measure:** self-reported general fatigue

**Time Frame:** base line; after finish the treatment (4 weeks) and 15 days after completing treatment.

### Eligibility Module

**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.

**Maximum Age:** 70 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eubeda@ucjc.edu

**Name:** Edurne Ú Docasar

**Phone:** +34918153131

**Role:** CONTACT

**Contact 2:**

**Name:** Edurne Ú Docasar

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University Camilo José Cela

**Name:** Edurne Ú Docasar

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M2454

- Name: Hyperthermia

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M8486

- Name: Fibromyalgia

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M12161

- Name: Myofascial Pain Syndromes

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005356

- Term: Fibromyalgia

- ID: D000009209

- Term: Myofascial Pain Syndromes

### Misc Info Module

- Version Holder: 2024-05-31
