NCT03801109

Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia

Completed NA Last updated 26 November 2021

What this trial tests

NA trial testing Hyperbaric group in Fibromyalgia in 69 participants. Completed in 26 June 2020.

Timeline

1 February 2019

Primary endpoint
23 December 2019

26 June 2020

Quick facts

Lead sponsor	University of Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	69
Start date	1 February 2019
Primary completion	23 December 2019
Estimated completion	26 June 2020
Sites	1 location across Spain

Drugs / interventions tested

• Hyperbaric group
• Magnetic group
• Physical group
• Baseline group

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

University of Valencia

Who can join

Adults 40 to 70, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms are back pain, headaches, irritable bowel, balance problems and deterioration of physical function in general. Patients with fibromyalgia (FM) often show pain at specific points that are known as "tender spots or tender spots, with an increased sensitivity to painful stimuli" (hyperalgesia) and a decreased pain threshold (allodynia). which can be evidenced in the physical examination and in the absence of anomalies that justify in the biological or image tests. These pain points to pressure, based on the most specific and specific criteria for the diagnosis of the disease, traditionally based on the criteria of the American College of Rheumatology (ACR), according to which, should be presented so minus 11 out of 18 painful points to confirm it. Although the etiology remains unknown and unclear, its appearance is attributed to a problem of central sensitization, that is, changes in central processing, which causes an alteration of the mechanisms that regulate the sensation of pain, with amplification of nociceptive input . and perpetuation of painful stimuli. Fibromyalgia is becoming a common syndrome in the countries of Western Europe, with a prevalence in the general population that ranges between 1-3%, and specifically in Spain, around 2.4%. In addition, it has a higher incidence in women than men (73-95%), predominantly affecting women between the ages of 40-50 years. About 3% of women with fibromyalgia are at an age when menopause occurs, so not only do they experience the symptoms of both states but they even exacerbate the syndrome with each other. On the other hand, and in relation to its chronicity, the care of this type of patients involves large costs for society with a significant consumption of health resources in the field of primary care, as well as the costs of work absenteeism. For these reasons, it is considered an important problem with a great impact on the health system, and therefore more and more studies are being developed with the aim of better understanding the pathophysiology of this disease. The therapeutic approach includes low cost and easy access measures, such as physical exercise (EF) programs to improve the symptoms of FM. Physical exercise has positive effects directly on pain, joint and muscle stiffness, generalized sensitivity and fatigue, among others, and secondarily on cognitive disorders. Thus, the vast majority of studies focus on low-impact aerobic exercise, performed between 60% and 70% of the maximum heart rate two to three times a week. However, to date, there is no study that compares the effectiveness of physical exercise with other innovative therapeutic actions, such as transcranial magnetic stimulation (TMS), the hyperbaric chamber (HBOT), in parameters related to pain and quality of life. the life of patients with fibromyalgia. The general objective is the effectiveness of transcranial magnetic stimulation and the hyperbaric chamber in women with fibromyalgia. As specific objectives we propose:

To assess the effect of HBOT, TMS and EF on quality of life in women with fibromyalgia.

* Object the effect of HBOT, TMS and EF in cortical functioning.
* Evaluate the effect of HBOT, TMS and EF on fatigue.
* Evaluate the effect of HBOT, TMS and EF on psychological aspects, such as depression and anxiety.
* Evaluate the effect of HBOT, TMS and EF on the perception of pain and the number of painful points.
* Evaluate the effect of HBOT, TMS and EF on the quality of sleep.
* Evaluate the effect of HBOT, TMS and EF on the quality of life.
* Evaluate the effect of HBOT, TMS and EF on the pain constructs.
* Determine the effect of HBOT, TMS and EF on plasma endorphin levels.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Low-Intensity Physical Exercise Improves Pain Catastrophizing and Other Psychological and Physical Aspects in Women with Fibromyalgia: A Randomized Controlled Trial.
   Izquierdo-Alventosa R, Inglés M, Cortés-Amador S, Gimeno-Mallench L, et al · · 2020 · cited 73× · PMID 32455853 · DOI 10.3390/ijerph17103634
2. Comparative study of the effectiveness of a low-pressure hyperbaric oxygen treatment and physical exercise in women with fibromyalgia: randomized clinical trial.
   Izquierdo-Alventosa R, Inglés M, Cortés-Amador S, Gimeno-Mallench L, et al · · 2020 · cited 16× · PMID 32636943 · DOI 10.1177/1759720x20930493
3. Effects of a low-pressure hyperbaric oxygen therapy on psychological constructs related to pain and quality of life in women with fibromyalgia: A randomized clinical trial.
   Izquierdo-Alventosa R, Inglés M, Cortés-Amador S, Muñoz-Gómez E, et al · · 2024 · cited 1× · PMID 38383268 · DOI 10.1016/j.medcli.2023.12.016