Trials / Terminated
TerminatedNCT00749554
Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain
Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Baylis Medical Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Disc biacuplasty | The lesion duration will be 15 minutes with a ramp rate of 2°C per minute and a peak set temperature of 45°C (Temperature in posterior annulus of disc reaches 65°C). |
| DEVICE | Sham biacuplasty | Probes not inserted into disc, no RF electricity applied. |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2010-08-01
- First posted
- 2008-09-09
- Last updated
- 2010-06-07
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00749554. Inclusion in this directory is not an endorsement.