Trial Outcomes & Findings for An Implantable Spinal Cord Stimulation Pain Management System (NCT NCT00205855)
NCT ID: NCT00205855
Last Updated: 2012-10-26
Results Overview
The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
2 weeks post initial fitting
Results posted on
2012-10-26
Participant Flow
Participant milestones
| Measure |
Spinal Cord Stimulation (SCS) Group
Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered "trial" durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Spinal Cord Stimulation (SCS) Group
Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered "trial" durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System.
|
|---|---|
|
Overall Study
Only received temporary implants
|
16
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
An Implantable Spinal Cord Stimulation Pain Management System
Baseline characteristics by cohort
| Measure |
Spinal Cord Stimulation (SCS) Group
n=65 Participants
Precision Spinal Cord Stimulation therapy group
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
|
Age Continuous
|
52 years
STANDARD_DEVIATION 14 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 weeks post initial fittingThe VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
Outcome measures
| Measure |
Spinal Cord Stimulation (SCS) Group
n=46 Participants
Precision Spinal Cord Stimulation therapy group
|
|---|---|
|
Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.
|
35 participants with > 50% VAS improvement
|
Adverse Events
Spinal Cord Stimulation (SCS) Group
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Spinal Cord Stimulation (SCS) Group
n=65 participants at risk
Precision Spinal Cord Stimulation therapy group
|
|---|---|
|
Surgical and medical procedures
Lead Migration
|
7.7%
5/65 • Number of events 5
|
|
Surgical and medical procedures
Loss of Therapy
|
1.5%
1/65 • Number of events 1
|
|
Surgical and medical procedures
New Lead Placement
|
3.1%
2/65 • Number of events 2
|
|
Infections and infestations
Infection
|
3.1%
2/65 • Number of events 2
|
|
Surgical and medical procedures
Implantable Pulse Generator Movement
|
1.5%
1/65 • Number of events 1
|
|
Surgical and medical procedures
Pain
|
1.5%
1/65 • Number of events 1
|
|
Surgical and medical procedures
Device Malfunction
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Death
|
1.5%
1/65 • Number of events 1
|
Other adverse events
| Measure |
Spinal Cord Stimulation (SCS) Group
n=65 participants at risk
Precision Spinal Cord Stimulation therapy group
|
|---|---|
|
Nervous system disorders
Abstinence syndrome
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
CSF leak
|
4.6%
3/65 • Number of events 3
|
|
Infections and infestations
Infection
|
1.5%
1/65 • Number of events 1
|
|
Surgical and medical procedures
Lead Migration
|
6.2%
4/65 • Number of events 4
|
|
Injury, poisoning and procedural complications
Device Malfunction
|
12.3%
8/65 • Number of events 8
|
|
Nervous system disorders
Grand-Mal Seizure
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Nausea & Vomiting
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Reduced Telemetry Range
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Seroma
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pain during SCS Trial
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Over and Under stimulation during SCS Trial
|
6.2%
4/65 • Number of events 4
|
|
Injury, poisoning and procedural complications
Unpleasant Stimulation
|
3.1%
2/65 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60