Effects of Diatermy in Patients With Fibromyalgia.

NCT06414369 | Completed

• 1 other identifier: CamiloJDF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia

Keywords

fibromyalgia; diathermy; pain; quality of life; chronic fatigue; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The impact of fibromyalgia.

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

• anxiety and depression

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

• sleep quality

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

• self-reported general fatigue

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Diathermy

Control group

PLACEBO COMPARATOR

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

Other: Simulated Diathermy

Interventions

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.

Experimental group

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.

Control group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience chronic generalized pain and be diagnosed with FM for at least three months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

University Camilo José Cela

Madrid, 28692, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Fever; Pain; Anxiety Disorders

Interventions

Diathermy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Edurne Ú Docasar

  University Camilo José Cela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: May 20, 2024
• Primary Completion: May 30, 2024
• Study Completion: July 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)