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

NCT01117870 | Completed Results

• 1 other identifier: PRF-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Back Pain

Keywords

chronic; pain; lumbar; Radicular

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  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.

  15 month point

• Number of Participants Lost to Follow-up at 3 Months

  Patients who were lost to follow-up at 3 months were recorded.

  3 months

Secondary Outcomes (4)

• Change in Mean Visual Analogue Scale (VAS) Scores From Baseline to 4 Weeks

  baseline (at recruitment) and at 4 Weeks

• Assessment of Side Effects

  1 week and up to 3 months

• Change in Oswestry Disability Index (ODI) From Baseline to 4 Week

  baseline (at recruitment) and at 4 weeks

• Number of Participants Who Discontinued Analgesics After Intervention

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.

Other: Placebo

Pulsed Radiofrequency

EXPERIMENTAL

PRF will be applied for 120 seconds at 42 degrees celsius.

Other: Pulsed Radiofrequency

Interventions

Pulsed Radiofrequency OTHER

120 seconds at 42 degrees celsius

Pulsed Radiofrequency

Placebo OTHER

Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• McMaster University: lead
• The Canadian Pain Society: collaborator

Study Sites (1)

East End Clinic, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Shanthanna H, Chan P, McChesney J, Paul J, Thabane L. Assessing the effectiveness of 'pulse radiofrequency treatment of dorsal root ganglion' in patients with chronic lumbar radicular pain: study protocol for a randomized control trial. Trials. 2012 Apr 28;13:52. doi: 10.1186/1745-6215-13-52.

  PMID: 22540851 DERIVED

MeSH Terms

Conditions

Chronic Pain; Back Pain; Bronchiolitis Obliterans Syndrome; Pain

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Results Point of Contact

• Title: Dr. Harsha Shanthanna
• Organization: McMaster University/ St. Joseph's Healthcare Hamilton

harshamd@gmail.com

905-522-1155

Study Officials

• Harsha Shanthanna, MD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• Philip Chan, MD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 6, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 21, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)