Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03882567
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2018-09-04
Brief Title:
Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia
Sponsor:
Universidad Rey Juan Carlos
Organization:
Universidad Rey Juan Carlos
Study Overview
Official Title:
Effectiveness of Electro Neuro Adaptive Regulator on Pain Disability and Central Sensitization in Patients With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2019-10
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:
SCENAR
Brief Summary:
Background There is evidence linking conditioned pain modulation CPM deficiency with musculoskeletal pain syndromes such as fibromyalgia Evidence shows that different physical therapies could activation situations of chronic pain there is no activation of CPM
Objectives The purpose of this study is to measure the CPM response and determine whether Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the improvement of CPM TS pain intensity disability
Design Double-blind randomized placebo clinical trial Methods Patients with fibromyalgia will be randomly allocated into two groups the Electro Neuro Adaptative Regulator group SCENAR or the sham technique ST group
Main outcomes measures Pain intensity with visual analogue scale Conditioned Pain Modulation CPM Temporal Summation TS and Pressure Pain Thresholds PPTs were the primary outcomes and will be assessed at baseline and at 3-months follow-up Secondary outcome measures were the Fibromyalgia Impact Questionnaire to measure disability Pain Catastrophizing Scale and the Pain Anxiety Symptoms Scale Beck Depression Inventory Jenkins Sleep Scale Questionnaire of quality of life SF36
Participants will be selected if they met the following inclusion criteria a fulfilled the 1990 and 2010 American College of Rheumatology classification criteria for FM b reported an average pain intensity 4 on a 0 to 10 cm visual analogue scale during the previous week to study commencement c were on stable doses of medication for FM 4 weeks and d were aged between 18 and 65 years
Objectives The purpose of this study is to measure the CPM response and determine whether Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the improvement of CPM TS pain intensity disability
Design Double-blind randomized placebo clinical trial Methods Patients with fibromyalgia will be randomly allocated into two groups the Electro Neuro Adaptative Regulator group SCENAR or the sham technique ST group
Main outcomes measures Pain intensity with visual analogue scale Conditioned Pain Modulation CPM Temporal Summation TS and Pressure Pain Thresholds PPTs were the primary outcomes and will be assessed at baseline and at 3-months follow-up Secondary outcome measures were the Fibromyalgia Impact Questionnaire to measure disability Pain Catastrophizing Scale and the Pain Anxiety Symptoms Scale Beck Depression Inventory Jenkins Sleep Scale Questionnaire of quality of life SF36
Participants will be selected if they met the following inclusion criteria a fulfilled the 1990 and 2010 American College of Rheumatology classification criteria for FM b reported an average pain intensity 4 on a 0 to 10 cm visual analogue scale during the previous week to study commencement c were on stable doses of medication for FM 4 weeks and d were aged between 18 and 65 years
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