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Primary Investigator Retired.
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| Name | Class |
|---|---|
| University of Alberta | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disc biacuplasty | Active Comparator |
| |
| Sham treatment. | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disc biacuplasty | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | 12 months | |
| Assessment of Quality of Life | 12 months | |
| SF-36 for physical functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Burnham, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lacombe Hospital | Lacombe | Alberta | T4L 1G8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18254768 | Background | Kapural L, Ng A, Dalton J, Mascha E, Kapural M, de la Garza M, Mekhail N. Intervertebral disc biacuplasty for the treatment of lumbar discogenic pain: results of a six-month follow-up. Pain Med. 2008 Jan-Feb;9(1):60-7. doi: 10.1111/j.1526-4637.2007.00407.x. | |
| 18489632 | Background | Kapural L. Intervertebral disk cooled bipolar radiofrequency (intradiskal biacuplasty) for the treatment of lumbar diskogenic pain: a 12-month follow-up of the pilot study. Pain Med. 2008 May-Jun;9(4):407-8. doi: 10.1111/j.1526-4637.2008.00464.x. No abstract available. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Sham biacuplasty | Device | Probes not inserted into disc, no RF electricity applied. |
|
| 12 months |
| Reduction in Medication Intake | 12 months |
| Patient satisfaction | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |