Ignite Creation Date:
2024-05-06 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05933941
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-06-19
Brief Title:
Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
Sponsor:
Camilo Jose Cela University
Organization:
Camilo Jose Cela University
Study Overview
Official Title:
Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
Status:
RECRUITING
Status Verified Date:
2024-09
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:
VRTCNPPFM
Brief Summary:
Fibromyalgia FM is a disease characterized by widespread pain fatigue and cognitive alterations among other symptoms neck pain being the most frequent and debilitating Virtual reality VR has emerged as a breakthrough for the treatment of such chronic conditions The objective of this study is to evaluate the efficacy of VR in the treatment of chronic neck pain in patients with FM Material and methods Single-blind randomized clinical trial study Patients with FM who meet the inclusion criteria will be recruited and will be distributed into three groups GC G1 G2 G1 VR cervical mobility exercises G2 cervical mobility exercises control group CG The treatment will be administered twice a week for 4 weeks Measurements of variables such as FIQ EQ-5D kinesiophobia pain VAS and algometer range of motion ROM fatigue and adherence to treatment will be performed
A follow-up is intended to be carried out 15 days and a month after the end of the study
A follow-up is intended to be carried out 15 days and a month after the end of the study
Detailed Description:
RESEARCH QUESTIONS Can virtual reality combined with exercise improve the quality of life and impact of fibromyalgia Can exercise performed with VR improve kinesiophobia cervical range of motion and pain Will VR lead to improvements in patients exercise functional capacity
The aim is to collect a sample of more than 50 patients with fibromyalgia and cervical pain lasting more than three months Variables to be collected include cervical range of motion measured with goniometry pain measured with a visual analog scale and pressure algometry at two cervical points kinesiophobia TSK questionnaire impact of fibromyalgia FIQ quality of life EQ-5D fatigue BORG visual scale disability caused by cervical pain questionnaire central sensitization questionnaire and functional capacity measured with the timed-up and go physical test
Recruitment was conducted through the Fibromyalgia and Chronic Pain Association of Mostoles A one-month treatment will be administered with two sessions per week with at least one day in between totaling 8 sessions lasting approximately 30 to 40 minutes each Measurements will be taken before starting the treatment at the end of the treatment 15 days after completion and 30 days after completing the entire treatment
Subjects will be randomized into three groups a control group CG that will not receive treatment Group 1 G1 that will receive cervical mobility exercise combined with exercise using virtual reality VR and Group 2 G2 that will receive cervical mobility exercise alone
The aim is to collect a sample of more than 50 patients with fibromyalgia and cervical pain lasting more than three months Variables to be collected include cervical range of motion measured with goniometry pain measured with a visual analog scale and pressure algometry at two cervical points kinesiophobia TSK questionnaire impact of fibromyalgia FIQ quality of life EQ-5D fatigue BORG visual scale disability caused by cervical pain questionnaire central sensitization questionnaire and functional capacity measured with the timed-up and go physical test
Recruitment was conducted through the Fibromyalgia and Chronic Pain Association of Mostoles A one-month treatment will be administered with two sessions per week with at least one day in between totaling 8 sessions lasting approximately 30 to 40 minutes each Measurements will be taken before starting the treatment at the end of the treatment 15 days after completion and 30 days after completing the entire treatment
Subjects will be randomized into three groups a control group CG that will not receive treatment Group 1 G1 that will receive cervical mobility exercise combined with exercise using virtual reality VR and Group 2 G2 that will receive cervical mobility exercise alone
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