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

This study has been completed.
Sponsor:
Collaborator:
The Canadian Pain Society
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01117870
First received: May 4, 2010
Last updated: April 23, 2013
Last verified: February 2012
  Purpose

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.


Condition Intervention
Chronic
Back Pain
Other: Pulsed RadioFrequency
Other: Placebo

Study Type: Interventional
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

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.
Other: Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117870

Locations
Canada, Ontario
East End Clinic, St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
The Canadian Pain Society
Investigators
Principal Investigator: Harsha Shanthanna, MD St. Joseph's Healthcare Hamilton
Principal Investigator: Philip Chan, MD St. Joseph's Healthcare Hamilton
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01117870     History of Changes
Other Study ID Numbers: PRF-1
Study First Received: May 4, 2010
Last Updated: April 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
chronic
pain
lumbar
Radicular

ClinicalTrials.gov processed this record on September 30, 2014