Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611397
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Discogen for Low Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic BackRadicular Leg Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be a double-blinded two-arm prospective randomized controlled pilot feasibility study in 40 evaluable subjects 20 in each arm at one study site within the United States Subjects in Arm 1 will receive unilateral Discogen treatment subjects in Arm 2 will receive unilateral sham treatment control Treatment in both arms can include medications eg NSAIDs or muscle relaxants for axial or radicular pain
Detailed Description:
This study will be a double-blinded two-arm prospective randomized controlled pilot feasibility study in 40 evaluable subjects 20 in each arm at one study site within the United States Subjects in Arm 1 will receive unilateral Discogen treatment subjects in Arm 2 will receive unilateral sham treatment control Treatment in both arms can include medications eg NSAIDs or muscle relaxants for axial or radicular pain This study will enroll 40 evaluable subjects and follow them for 60 days
1 Investigate the safety and feasibility of the Discogen device to alleviate backradicular leg pain
2 Assess the mean reduction in back and radicular leg pain following Discogen treatment
Primary Safety - collection of all adverse events including any device- or procedure-related adverse events
Primary Effectiveness -percent change from baseline for Numerical Pain Scale NPS radicular leg pain at 30 and 60 days The scale ranges from 0No pain to 10 Severe pain
Secondary Effectiveness
Change from baseline in Oswestry Disability Index at 30 and 60 days The Index ranges from 0-20 minimal disability 21-40 moderate disability 41-60 severe disability 61-80 crippled to 81-100 bed bound
Percent change from baseline NPS back pain at 30 and 60 days
1 Investigate the safety and feasibility of the Discogen device to alleviate backradicular leg pain
2 Assess the mean reduction in back and radicular leg pain following Discogen treatment
Primary Safety - collection of all adverse events including any device- or procedure-related adverse events
Primary Effectiveness -percent change from baseline for Numerical Pain Scale NPS radicular leg pain at 30 and 60 days The scale ranges from 0No pain to 10 Severe pain
Secondary Effectiveness
Change from baseline in Oswestry Disability Index at 30 and 60 days The Index ranges from 0-20 minimal disability 21-40 moderate disability 41-60 severe disability 61-80 crippled to 81-100 bed bound
Percent change from baseline NPS back pain at 30 and 60 days
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