Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272539
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-15
Brief Title:
Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome
Sponsor:
Fundación Universidad Católica de Valencia San Vicente Mártir
Organization:
Fundación Universidad Católica de Valencia San Vicente Mártir
Study Overview
Official Title:
Spinal Cord Stimulation Combined With Exercise in Patients Diagnosed With Persistent Spinal Pain Syndrome A Randomized Control Trial RCT
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Introduction At the neurophysiological level it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome PSPS-T12 potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain Administration of high doses of spinal cord stimulation to individuals with PSPS-T12 may induce supraspinal descending activation Similarly exercise is recognized as a fundamental aspect of spinal pain management Studies have demonstrated its impact on neurophysiological factors including the release of spinal and supraspinal beta-endorphins which activate μ-opioid receptors Therefore the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain quality of life and disability in failed back surgery syndrome FBSS patients MethodsMaterials A double-blind randomized clinical trial RCT has been designed All participants will be randomized from a pre-set sequence The intervention design has been elaborated from the CONSORT guidelines This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area protocol number PI 2023 101435 in 24012024 in accordance with the ethical guidelines of the Helsinki declaration Sample size was calculated using G Power Sample size software University of Düsseldorf The calculation was based on a moderate effect size of 04 partial η2 040 α 05 power 090 resulting in a total of 28 patients Assuming a 30 dropout rate 36 participants will be recruited in total Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions Each work session will have a duration of 60 minutes The exercise will be adapted according to the phases based on the results already published limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration Primary outcomes will be functionality satisfaction strength psychosocial variables quality of life and pain perception
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