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

This study has been completed.
Sponsor:
Collaborator:
Canadian Pain Society
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01117870
First received: May 4, 2010
Last updated: January 30, 2017
Last verified: January 2017
  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 Pain
Back Pain
Other: Pulsed Radiofrequency
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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: Pulsed Radiofrequency
PRF will be applied for 120 seconds at 42 degrees celsius.
Other: Pulsed Radiofrequency
120 seconds at 42 degrees celsius

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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

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
Results First Received: June 6, 2016
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by McMaster University:
chronic
pain
lumbar
Radicular

Additional relevant MeSH terms:
Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on March 29, 2017