Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia
Kľúčové slová
Abstrakt
Termíny
Naposledy overené: | 11/30/2019 |
Prvý príspevok: | 11/13/2018 |
Odhadovaná registrácia bola odoslaná: | 01/07/2019 |
Prvý príspevok: | 01/10/2019 |
Posledná aktualizácia bola odoslaná: | 04/05/2020 |
Posledná aktualizácia bola zverejnená: | 04/06/2020 |
Aktuálny dátum začatia štúdie: | 01/31/2019 |
Odhadovaný dátum dokončenia primárneho okruhu: | 12/22/2019 |
Odhadovaný dátum dokončenia štúdie: | 06/25/2020 |
Stav alebo choroba
Intervencia / liečba
Other: Hyperbaric group
Other: Magnetic group
Other: Physical group
Other: Physical group
Fáza
Skupiny zbraní
Arm | Intervencia / liečba |
---|---|
Experimental: Hyperbaric group | Other: 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. |
Experimental: Magnetic group | 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. |
Active Comparator: Physical group | 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. |
No Intervention: Baseline group |
Kritériá oprávnenosti
Vek vhodný na štúdium | 40 Years To 40 Years |
Pohlavia vhodné na štúdium | Female |
Prijíma zdravých dobrovoľníkov | Áno |
Kritériá | 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. |
Výsledok
Primárne výstupné opatrenia
1. Changes in pain intensity [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.]
Opatrenia sekundárnych výsledkov
1. Rating of pain [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
2. Pain catastrophizing [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
3. Acceptance of pain [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
4. Pain self perception [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
5. Psychological inflexibility [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
6. Number of painful points [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
7. Quality of life: perceived well-being [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
8. Quality of sleep [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
9. Level of depression [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
10. Level of stress [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
11. Level of anxiety [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
12. Evoked motor potential [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
13. Motor threshold [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]
14. Plasma pain biomarkers. [Hyperbaric, Physical and Baseline groups: baseline and 8 weeks. Magnetic group: baseline and 3 weeks]