Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain
Pulsed RadioFrequency (PRF) is a relatively new technique derived from a well established and proven intervention, thermal radiofrequency (RF). Both procedures are used in the treatment of chronic pain. Unlike RF treatment, PRF does no direct damage to the nerve. During PRF treatment, electrical energy is applied with a small needle to the affected nerve using a pulsed time cycle that delivers short bursts of RF current. This study is interested in looking at the efficacy of PRF for chronic lumbar radicular pain (CLR) and to assess whether a larger scale clinical study with the same methods can be used.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Placebo Controlled, Double-blinded Trial to Assess the Effectiveness of Pulse RadioFrequency Treatment of Dorsal Root Ganglion in Patients With Chronic Lumbar Radicular Pain|
- Feasibility of doing a larger scale trial [ Time Frame: 8 month point ] [ Designated as safety issue: No ]Expected recruitment is at least 4 patients per month. At least 80% of eligible patients fulfilling the selection criteria can be recruited. The final assessment will be at the end of 8 months, at which time all the expected number of subjects must have been enrolled. Participants withdrawing within 4 weeks after the interventional shall not be included in the study. However participants withdrawing after 4 weeks of the intervention shall be included in the final analysis, on intention to treat principle.
- Is PRF an effective treatment for patients with CLR pain? [ Time Frame: 4 week point ] [ Designated as safety issue: No ]Is PRF an effective treatment for patients with CLR pain? It will be measured by a decrease in VAS scores from baseline measurement at recruitment. The definition would be at least a 50% decrease of VAS scores at the 4 week assessment. Definition of success, at east 50% decrease in VAS scores assessed at 4 weeks.
- Assessment of short term side effects and persisting side effects [ Time Frame: 1 week or longer ] [ Designated as safety issue: Yes ]Percentage of patients having side effects after PRF treatment assessed at 1 week compared to placebo group. Assessment of persisting side effects, percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment
- Improvement in Oswestry Disability Index (ODI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Success defined as at least 50% improvement in ODI-measured at 4 weeks compared to placebo group.
- Decrease in the analgesic medications used. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Percentage of patients with increase or decrease in medication use (either in dose, frequency, or no use), compared with the placebo group.
|Study Start Date:||July 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.
Experimental: PRF treatment
PRF will be applied for 120 seconds at 42 degrees celsius.
Other: Pulsed RadioFrequency
120 seconds at 42 degrees celsius
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117870
|East End Clinic, St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Harsha Shanthanna, MD||St. Joseph's Healthcare Hamilton|
|Principal Investigator:||Philip Chan, MD||St. Joseph's Healthcare Hamilton|