A Single-Blind, Prospective, Randomised Control Trial Comparing Two Radiofrequency Neurotomy (RFN) Techniques For the Treatment of Chronic Lower Back Pain Originating from Facet Joints
- Conditions
- Chronic Lower Back PainNeurological - Other neurological disorders
- Registration Number
- ACTRN12618001041246
- Lead Sponsor
- Monash Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 98
To participate in this study, subjects must meet all of the following inclusion criteria:
1.Have been diagnosed with lumbar medial branch derived facet pain via positive medial branch blocks
2.Have received pain relief from a prior RFN procedure.
3.Have agreed to undergo another RFN treatment.
4.Have an average pain intensity of 5 or more out of 10 on the NPRS.
5.Aged 40 to 70 years of age.
6.Be capable of subjective evaluation, able to read and understand ethics committee approved written questionnaires, and are able to read, understand and sign the EC-approved written informed consent, all of which will be in Australian English.
7.Be willing and able to comply with study-related requirements, procedures and visits.
To participate in this study, subjects must not meet any of the following exclusion criteria:
8.Have a body mass index (BMI) >40.
9.Unable to give informed consent.
10.Have a medical condition or pain in other area(s) not intended to be treated with RFN, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
11.Have evidence of an active disruptive psychological disorder or other known condition significant enough to impact perception of pain and/or the ability to evaluate treatment outcome as determined by the investigator and the subject’s medical history.
12.Have a co-existing major illness which may interfere with the treatment, as determined by the investigator.
13.Are currently taking > 10 morphine milligram equivalents (MME) per day.
14.Are suffering pain that is different to the previously treated pain from RFN treatment.
15.Are on workcover, TAC or similar.
16.Need treatment for 4 or more spine levels on one side.
17.Have a life expectancy of less than 1 year.
18.Be pregnant or planning to become pregnant during the course of the study (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
19.Have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs).
20.Be concomitantly participating or planning to participate in another clinical study overlapping in time with the present clinical study.
21.Have a condition currently requiring or likely to require surgery during the study period.
22.Be concomitantly undertaking a physical therapy regimen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be a comparison of pain intensity scores with the NPRS between the two groups[2 months after the intervention]
- Secondary Outcome Measures
Name Time Method Comparison of pain intensity scores with the NPRS between the two groups[1, 6 and 12 months after the intervention.];Comparison of Depression, Anxiety and Stress Scores (DASS21) between the two groups[1, 2, 6 and 12 months after the intervention];Comparison of Oswestry Disability Index (ODI) scores between the two groups[1, 2, 6 and 12 months after the intervention]