Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
1 other identifier
interventional
40
1 country
1
Brief Summary
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-pain
Started Sep 2013
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
March 16, 2021
CompletedMarch 16, 2021
February 1, 2021
2.7 years
October 15, 2013
February 1, 2018
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numeric Rating Scale (Pain)
0 (no pain)- 10 (worst pain imaginable)
Weeks 4, 6 and 8
Secondary Outcomes (1)
Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.
weeks 4, 6, and 8
Study Arms (3)
program 1
ACTIVE COMPARATORpreset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
program 2
ACTIVE COMPARATORpreset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
program 3
ACTIVE COMPARATORpreset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs
Interventions
Change to different present program using epidural and peripheral lead to cover pain
Eligibility Criteria
You may qualify if:
- spinal cord stimulator implant within last 3 weeks
- NRS \> 6
- at least 22 years old
- patients who agree not to add or increase their pain medications during the study
You may not qualify if:
- patients with prior spinal cord stimulators
- pregnancy
- infusion pump
- history of substance abuse or dependency in last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolinas Center For Advanced Management of Pain
Spartanburg, South Carolina, 29303, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- J Kelby Hutcheson MD
- Organization
- CCAMP
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 15, 2013
First Posted
January 27, 2015
Study Start
September 1, 2013
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
March 16, 2021
Results First Posted
March 16, 2021
Record last verified: 2021-02