Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05998889
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-07-25
Brief Title:
Feasibility of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
Sponsor:
University of Vic - Central University of Catalonia
Organization:
University of Vic - Central University of Catalonia
Study Overview
Official Title:
A Feasibility Study of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1
Status:
RECRUITING
Status Verified Date:
2024-01
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:
ABILITIES-1
Brief Summary:
Background
There is low quality evidence supporting the use of rehabilitation in Complex Regional Pain Syndrome CRPS despite it is the first line approach in the Guidelines Graded Motor Imagery GMI may be useful to improve pain and function at mid term 6 months Graded Pain Exposure Approaches GPE seem to improve pain but not function at mid term In other type of chronic pain conditions GPE offers better outcomes than pain contingent exercises avoiding pain approaches at short term 3 months and similar at mid term Following the recommendations of Authors we will evaluate the efficacy and safety of a combined therapy of GMI and GPE in people with CRPS type 1
Objective
To evaluate the feasibility of a combined therapy of GPE and GMI in front of only GMI in people with CRPS-1 and the clinical impact on the primary outcome Severity of the disease of the intervention
Design
Feasibility Randomized controlled Trial single blind of evaluator 2 parallel arms Measurement pre-intervention post-intervention 1 and 3 months follow-up
Population
People 18 years old or above with CRPS type 1 diagnosed by Budapest criteria and 1 without any psychological or psychiatric disease 2 nor any neurosensorial issue that could compromise the realization of the therapy proposed 3 neither any major surgery intervention related to CRPS eg neurostimulation or sympathectomy 4 nor minor intervention on the last 3 months eg nerve blocks
Outcomes
Primary outcomes Complex Regional Pain Syndrome Severity Scale severity of the disease and Safety Outcomes oedema pain temperature Range of Motion Secondary outcomes 5Q-5D-5L quality of life SF-MPQ Quality Intensity and location of pain PPT pain pressure threshold CPM pain inhibition pathways FAAM or Quick Dash function PCS catastrophism Self efficacy in chronic pain questionnaire self-efficacy Dynamometry Hand Grip strength
There is low quality evidence supporting the use of rehabilitation in Complex Regional Pain Syndrome CRPS despite it is the first line approach in the Guidelines Graded Motor Imagery GMI may be useful to improve pain and function at mid term 6 months Graded Pain Exposure Approaches GPE seem to improve pain but not function at mid term In other type of chronic pain conditions GPE offers better outcomes than pain contingent exercises avoiding pain approaches at short term 3 months and similar at mid term Following the recommendations of Authors we will evaluate the efficacy and safety of a combined therapy of GMI and GPE in people with CRPS type 1
Objective
To evaluate the feasibility of a combined therapy of GPE and GMI in front of only GMI in people with CRPS-1 and the clinical impact on the primary outcome Severity of the disease of the intervention
Design
Feasibility Randomized controlled Trial single blind of evaluator 2 parallel arms Measurement pre-intervention post-intervention 1 and 3 months follow-up
Population
People 18 years old or above with CRPS type 1 diagnosed by Budapest criteria and 1 without any psychological or psychiatric disease 2 nor any neurosensorial issue that could compromise the realization of the therapy proposed 3 neither any major surgery intervention related to CRPS eg neurostimulation or sympathectomy 4 nor minor intervention on the last 3 months eg nerve blocks
Outcomes
Primary outcomes Complex Regional Pain Syndrome Severity Scale severity of the disease and Safety Outcomes oedema pain temperature Range of Motion Secondary outcomes 5Q-5D-5L quality of life SF-MPQ Quality Intensity and location of pain PPT pain pressure threshold CPM pain inhibition pathways FAAM or Quick Dash function PCS catastrophism Self efficacy in chronic pain questionnaire self-efficacy Dynamometry Hand Grip strength
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