Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616181
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
TDCS and Tele-rehabilitation Exercise in Fibromyalgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia The study will compare these effects with each other and with placebo tDCS on the following variables pain intensity pain mechanosensitivity quality of life fatigue anxiety depression sleep quality pain catastrophizing functional capacity isometric strength and exercise adherence
Secondary objectives include
Describing the sociodemographic clinical and functional characteristics of fibromyalgia patients
Comparing exercise intensity levels between patients receiving tDCS on M1 DLPFC and placebo stimulation
Reporting any adverse effects of the intervention Adult participants with fibromyalgia will be randomized into three groups a anodal tDCS over M1 telerehabilitation b anodal tDCS over DLPFC telerehabilitation and c sham-tDCS telerehabilitation The intervention will last for 12 weeks The telerehabilitation exercise program will include an aerobic phase and a resistance phase with four intensity levels regulated based on the Borg Rating of Perceived Exertion 0-10 The program will be conducted remotely through phone contact with materials and videos provided to guide exercise execution tDCS will be applied once per week for 20 minutes at 2 mA either over M1 or DLPFC
The dependent variables-pain intensity fibromyalgia impact fatigue anxiety and depression levels pain catastrophizing sleep quality functional capacity and isometric muscle strength-will be collected in the week prior to the intervention the week following the intervention and 12 weeks after its completion Additionally pain intensity fibromyalgia impact fatigue severity anxiety and depression levels pain catastrophizing and sleep quality will be evaluated during the 6th week of the intervention
Exercise intensity exercise adherence and any adverse effects related to the intervention will be recorded weekly
Secondary objectives include
Describing the sociodemographic clinical and functional characteristics of fibromyalgia patients
Comparing exercise intensity levels between patients receiving tDCS on M1 DLPFC and placebo stimulation
Reporting any adverse effects of the intervention Adult participants with fibromyalgia will be randomized into three groups a anodal tDCS over M1 telerehabilitation b anodal tDCS over DLPFC telerehabilitation and c sham-tDCS telerehabilitation The intervention will last for 12 weeks The telerehabilitation exercise program will include an aerobic phase and a resistance phase with four intensity levels regulated based on the Borg Rating of Perceived Exertion 0-10 The program will be conducted remotely through phone contact with materials and videos provided to guide exercise execution tDCS will be applied once per week for 20 minutes at 2 mA either over M1 or DLPFC
The dependent variables-pain intensity fibromyalgia impact fatigue anxiety and depression levels pain catastrophizing sleep quality functional capacity and isometric muscle strength-will be collected in the week prior to the intervention the week following the intervention and 12 weeks after its completion Additionally pain intensity fibromyalgia impact fatigue severity anxiety and depression levels pain catastrophizing and sleep quality will be evaluated during the 6th week of the intervention
Exercise intensity exercise adherence and any adverse effects related to the intervention will be recorded weekly
Detailed Description:
None
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