Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03801109
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2018-11-14
Brief Title:
Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Study of the Effectiveness of Transcranial Magnetic Stimulation and the Hyperbaric Chamber in Women With Fibromyalgia Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 24 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None