Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain
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|ClinicalTrials.gov Identifier: NCT01117870|
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : March 21, 2017
Last Update Posted : March 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Back Pain||Other: Pulsed Radiofrequency Other: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||November 2012|
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: Pulsed Radiofrequency
PRF will be applied for 120 seconds at 42 degrees celsius.
Other: Pulsed Radiofrequency
120 seconds at 42 degrees celsius
- Recruitment Rate [ Time Frame: 15 month point ]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 was at the end of 15 months, at which time all the subjects were 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.
- Number of Participants Lost to Follow-up at 3 Months [ Time Frame: 3 months ]Patients who were lost to follow-up at 3 months were recorded.
- Change in Mean Visual Analogue Scale (VAS) Scores From Baseline to 4 Weeks [ Time Frame: baseline (at recruitment) and at 4 Weeks ]
Secondary outcomes were considered as exploratory. Is PRF an effective treatment for patients with CLR pain? It will be measured by a change in VAS scores from baseline measurement at recruitment.
Visual analog scale (VAS) - For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10) on a 10-cm scale.
- Assessment of Side Effects [ Time Frame: 1 week and up to 3 months ]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
- Change in Oswestry Disability Index (ODI) From Baseline to 4 Week [ Time Frame: baseline (at recruitment) and at 4 weeks ]ODI is an index derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to: care for oneself, walk, sit, sexual function, stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
- Number of Participants Who Discontinued Analgesics After Intervention [ Time Frame: 4 weeks ]Number of PRF treatment patients with increase or decrease in medication use (either in dose, frequency, or no use), compared with the placebo group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|