Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00887419
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2009-04-23
Brief Title:
Spinal Cord Stimulator Implant Study
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates
Status:
COMPLETED
Status Verified Date:
2018-07
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:
SCS
Brief Summary:
This study is for patients who have been approved by their doctors and insurance companies to receive spinal cord stimulator implants
The goal of this study is to investigate if pain and disability is improved in patients with an implant in combination with coping skills training These patients are compared with those with an implant that receive chronic education information and those with an implant that are in the control group and receive no additional training or information
The goal of this study is to investigate if pain and disability is improved in patients with an implant in combination with coping skills training These patients are compared with those with an implant that receive chronic education information and those with an implant that are in the control group and receive no additional training or information
Detailed Description:
This study tests the hypotheses that a pain coping skills program in combination with an SCS implant can improve short- and long-term outcomes in self-efficacy for coping with chronic pain physical disability psychological distress and pain intensity
Participants are patients who have been approved by their doctors and insurance companies to receive the spinal cord stimulator trial After patients have been approved they can be enrolled in this study After completing a baseline evaluation patients are randomized into 1six individual pain coping skills training sessionsrelaxations techniques communication skills goal setting 2 six individual chronic pain education sessions discussion approach to etiology and treatment of chronic pain and information on spinal cord stimulator implants or 3 treatment as usual no study intervention
Participants are evaluated prior to or shortly after their surgery at post treatment at 6 month follow-up and at 12 month follow-up All participants continue their routine medical care throughout the study
Participants are patients who have been approved by their doctors and insurance companies to receive the spinal cord stimulator trial After patients have been approved they can be enrolled in this study After completing a baseline evaluation patients are randomized into 1six individual pain coping skills training sessionsrelaxations techniques communication skills goal setting 2 six individual chronic pain education sessions discussion approach to etiology and treatment of chronic pain and information on spinal cord stimulator implants or 3 treatment as usual no study intervention
Participants are evaluated prior to or shortly after their surgery at post treatment at 6 month follow-up and at 12 month follow-up All participants continue their routine medical care throughout the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH R01-NS-053759 | None | None | None |