Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia

NCT ID: NCT03801109

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-06-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hyperbaric group

Group Type: EXPERIMENTAL

Hyperbaric group

Intervention Type: 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.

Magnetic group

Group Type: EXPERIMENTAL

Magnetic group

Intervention Type: 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.

Physical group

Group Type: ACTIVE_COMPARATOR

Physical group

Intervention Type: OTHER

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

Baseline group

Intervention Type: OTHER

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

Baseline group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric group

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.

Intervention Type: OTHER

Magnetic group

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.

Intervention Type: OTHER

Physical group

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

Intervention Type: OTHER

Baseline group

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruth Izquierdo Alventosa, PT

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

Fundación Fivan

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 38383268 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34216139 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32636943 (View on PubMed)

Other Identifiers

H1548771544856

Identifier Type: -

Identifier Source: org_study_id