Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554106
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Neuromuscular Electrical Stimulation in Fibromyalgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Neuromuscular Electrical Stimulation in Fibromyalgia Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia syndrome FMS is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology ACR 1990 criteria Neuromuscular electrical stimulation NMES stimulates nerve fibers providing innervation in healthy muscle and muscle fibers in denervated muscle to produce contraction All patients will be taught neck normal joint motion exercises upper trapezius stretching exercise and posture exercises Patients included in the study will be randomly distributed equally between the two groups In addition to the study group NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks Pain disability and sleep quality of all patients will be evaluated
Detailed Description:
Fibromyalgia syndrome FMS is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the 1990 criteria of the American College of Rheumatology ACR 1 Pain and other symptoms associated with fibromyalgia interfere with daily functions work and social activities leading to a decrease in quality of life Neuromuscular electrical stimulation NMES stimulates nerve fibers that provide innervation in healthy muscle and muscle fibers in denervated muscle to produce contraction Studies on TENS current in patients with FM have shown that pain decreases and functional status improves However although muscle weakness has been described in patients with FM there are no studies on the effects of NMES application All patients will be taught neck normal joint motion exercises upper trapezius stretching exercise and posture exercises Patients included in the study will be randomly distributed equally between the two groups In addition to the study group NMES will be applied to the upper trapezius muscle for 30 minutes 5 days a week for 4 weeks Pain disability and sleep quality of all patients will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None