Clinical trial NCT03801109: Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia
Official title: Study of the Effectiveness of Transcranial Magnetic Stimulation and the Hyperbaric Chamber in Women With Fibromyalgia. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: transcranial magnetic stimulation
hyperbaric chamber
pain
endorphins
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 69
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology of 1990.
* Having taken pharmacological treatment for more than three months without clinical improvement.
* Have the capacity to sign the informed consent form in accordance.
* Not having previously received treatment with a hyperbaric chamber or transcranial magnetic stimulation.
* Absence of other pathologies associated with the locomotor system at an advanced stage that makes physical activity impossible (arthritis, osteoarthritis, uric acid).

Exclusion Criteria:

* Pregnancy or lactation period.
* Epilepsy, drugs that lower the convulsive threshold, history of intense headaches, e endocranial and auditory elements, pathology related to the nervous system, either central or peripheral, not associated with fibromyalgia, endocranial hypertension.
* Hospital hypertension not controlled, heart and / or respiratory failure, cardiac pacemaker, pneumothorax.
* Claustrofobia and / or psychiatric pathologies; schizophrenia, bipolar disorder, psychosis.
* Patients with problems of alcohol addiction, psychoactive drugs or narcotics.
* Patients presenting neoplasia.
* Surgical interventions of less than 4 months.
* Tympanic perforations.
* Cardiac slides.

Primary outcomes:
measure: Changes in pain intensity
timeFrame: Hyperbaric, Physical and Baseline groups: change from baseline in the intensity of pain at 8 weeks. Magnetic group: change from baseline in the intensity of pain at 3 weeks.
Secondary outcomes:
measure: Rating of pain
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Pain catastrophizing
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Acceptance of pain
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Pain self perception
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Psychological inflexibility
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Number of painful points
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Quality of life: perceived well-being
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Quality of sleep
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Level of depression
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Level of stress
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Level of anxiety
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Evoked motor potential
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Motor threshold
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
measure: Plasma pain biomarkers.
timeFrame: Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Fundación Fivan
Study officials:
affiliation: University of Valencia
name: Ruth Izquierdo Alventosa, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Gimeno-Mallench L, Sempere-Rubio N, Serra-Ano P. Effectiveness of High-Frequency Transcranial Magnetic Stimulation and Physical Exercise in Women With Fibromyalgia: A Randomized Controlled Trial. Phys Ther. 2021 Oct 1;101(10):pzab159. doi: 10.1093/ptj/pzab159.
citation: Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Gimeno-Mallench L, Sempere-Rubio N, Chirivella J, Serra-Ano P. Comparative study of the effectiveness of a low-pressure hyperbaric oxygen treatment and physical exercise in women with fibromyalgia: randomized clinical trial. Ther Adv Musculoskelet Dis. 2020 Jun 24;12:1759720X20930493. doi: 10.1177/1759720X20930493. eCollection 2020.