Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117870
• Other study ID #: PRF-1
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: April 23, 2013
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic

Intervention

Other:
• Pulsed RadioFrequency
120 seconds at 42 degrees celsius
• Placebo
Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.

Locations

Country	Name	City	State
Canada	East End Clinic, St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	The Canadian Pain Society

Country where clinical trial is conducted

Canada, 

Outcome

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