Trial Outcomes & Findings for Spinal Cord Stimulation for Low Back Pain (NCT NCT00205868)
NCT ID: NCT00205868
Last Updated: 2021-06-18
Results Overview
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
COMPLETED
PHASE4
304 participants
1 year
2021-06-18
Participant Flow
Efforts were made but the information is not accessible at this time. Hence assignment not available.
Participant milestones
| Measure |
Spinal Cord Stimulation
Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
|
|---|---|
|
Overall Study
STARTED
|
304
|
|
Overall Study
COMPLETED
|
304
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Cord Stimulation for Low Back Pain
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.
Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.
Outcome measures
Outcome data not reported
Adverse Events
Spinal Cord Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place