Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia

NCT03801109 | Completed

• 1 other identifier: H1548771544856
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

transcranial magnetic stimulation; hyperbaric chamber; pain; endorphins

Outcome Measures

Primary Outcomes (1)

• Changes in pain intensity

  Analog visual scale

  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 (14)

• Rating of pain

  Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks

• Pain catastrophizing

  Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks

• Acceptance of pain

  Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks

• Pain self perception

  Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks

• Psychological inflexibility

  Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks

Study Arms (4)

Hyperbaric group

EXPERIMENTAL

Other: Hyperbaric group

Magnetic group

EXPERIMENTAL

Other: Magnetic group

Physical group

ACTIVE COMPARATOR

Other: Physical group; Other: Baseline group

Baseline group

NO INTERVENTION

Interventions

Hyperbaric group OTHER

Participants in this group performed 5 sessions per week for 8 weeks (40 sessions in total) . The time of each session is 90 minutes and the chamber pressure is 1.4 ATA with a 100% oxygen mask.

Hyperbaric group

Magnetic group OTHER

There will be 5 sessions per week for 2 consecutive weeks (10 sessions in total), stimulating the left motor cortex at high frequencies, 10 Hz, for 30 minutes.

Magnetic group

Physical group OTHER

A protocol of low-impact physical exercise will be performed twice a week for 8 weeks, with a total of 16 sessions.

Physical group

Baseline group OTHER

This group will be the control group that did not take any action, perform the activities of daily life

Physical group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Fundación Fivan

Valencia, 46005, Spain

Location

Related Publications (3)

• Izquierdo-Alventosa R, Ingles M, Cortes-Amador S, Munoz-Gomez E, Molla-Casanova S, Gimeno-Mallench L, Chrivella-Garrido J, Serra-Ano P. 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. Med Clin (Barc). 2024 Jun 14;162(11):516-522. doi: 10.1016/j.medcli.2023.12.016. Epub 2024 Feb 20. English, Spanish.

  PMID: 38383268 DERIVED

• 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.

  PMID: 34216139 DERIVED

• 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.

  PMID: 32636943 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Ruth Izquierdo Alventosa, PT

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: January 11, 2019
• Study Start: February 1, 2019
• Primary Completion: December 23, 2019
• Study Completion: June 26, 2020
• Last Updated: November 26, 2021

Record last verified: 2019-12

Locations

ES (1)