Back Pain Clinical Trial
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
Verified date | February 2012 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | November 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - > 18 years of age - CLR for at least 4 months of more, with concordant findings on either MRI and CT scan - VAS score of at least 60/100 at presentation - informed consent Exclusion Criteria: - < 18 years of age - patient refusal - any contraindication to neuraxial injection such as coagulation disturbance, anticoagulant therapy, bleeding disorder, or infection at site of injection - anatomical deformity or derangement, either congenital or surgical such as: extreme scoliosis, previous implant or instrumentation making it difficult to access the foramen as evidence by MRI, CT, or plain x-rays - uncontrolled diabetes or severe coronary vascular disease necessitating continuation of anticoagulation therapy - known history of psychiatric illness-such as depression or psychosis - presence of cancer accounting for present symptoms - patient's inability of communicate in English and inability to understand and fill out the required follow-up questionnaire and form - allergy to local anesthetics or steroid or contrast medium - any patient with a history of acute neurological weakness or neurodeficit in the affected limb in terms of measurable motor weakness or abnormal reflexes |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | East End Clinic, St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | The Canadian Pain Society |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of doing a larger scale trial | 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. | 8 month point | No |
Secondary | Is PRF an effective treatment for patients with CLR pain? | 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. | 4 week point | No |
Secondary | Assessment of short term side effects and persisting side effects | 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 | 1 week or longer | Yes |
Secondary | Improvement in Oswestry Disability Index (ODI) | Success defined as at least 50% improvement in ODI-measured at 4 weeks compared to placebo group. | 4 weeks | No |
Secondary | Decrease in the analgesic medications used. | Percentage of patients with increase or decrease in medication use (either in dose, frequency, or no use), compared with the placebo group. | 4 weeks | No |
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