Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000426583
Ethics application status
Approved
Date submitted
16/02/2015
Date registered
5/05/2015
Date last updated
5/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiofrequency (RF) ablation for the treatment of chronic lumbar facets arthropathy; comparing the use of bipolar RF at two points versus monopolar RF at one point
Scientific title
Radiofrequency (RF) ablation for the treatment of chronic lumbar facets arthropathy; comparing the use of bipolar RF at two points versus monopolar RF at one point
Secondary ID [1] 286136 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic lumbar facets arthropathy 294142 0
low back pain 294143 0
Condition category
Condition code
Anaesthesiology 294463 294463 0 0
Pain management
Musculoskeletal 294987 294987 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be under one of the two procedures according to the randomization.
All patients will have the procedure once only by aqualified anesthetist specialized in pain management under fluoroscopic guidance with use of Cosman RF generator G4TM, 20 gauge curved sharp cannula, 10 cm shaft,
10 mm tip and 10 cm electrodes (Cosman autoclavable CSK-TC10).
1. Group 1: Thirty patients....Two RF needles are inserted at transverse process(10 mm distance is kept between the two needles). After sensory and motor stimulation for both sites, bipolar lesion RF at 80 degrees Celsius for 90 sec will be applied.

2. Group 2: Thirty patients.....One needle will be inserted at the transverse process. After sensory and motor stimulation, monopolar lesion RF at 80 degrees Celsius for 90 sec will be applied.
Intervention code [1] 291136 0
Treatment: Devices
Comparator / control treatment
active control using monopolar lesion RF (a procedure incorporating heat at the active tip of a single electrode to interrupt pain signals travelling through spinal nerves)

a temperature of 80 degrees Celsius will be applied for 90 sec once only.

tools used: Cosman RF generator G4TM, 20 gauge curved sharp cannula with 10 cm shaft and 10 mm tip with 10 cm electrodes (Cosman autoclavable CSK-TC10).

procedure is done by an qualified anesthetist specialized in pain management
Control group
Active

Outcomes
Primary outcome [1] 294247 0
Patients will be evaluated by a specialized pain nurse unaware of the method used intraooperatively. Evaluation will be done after 2 weeks, one month, 3 months for pain score using the visual analogue pain scale.
Timepoint [1] 294247 0
Evaluation will be done 2 weeks, one month and 3 months after the procedure.
Secondary outcome [1] 312871 0
Overall patient satisfaction with pain relief will be evaluated by patient satisfaction questionnaire from 1 to 6 according to the following.
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
6..very poor
Timepoint [1] 312871 0
6 months after the procedure

Eligibility
Key inclusion criteria
*18 years old or older.
*Moderate-to-severe low back pain for more than six months with tenderness over lumbar fact joint.
*Pain is not responding to the usual medical treatment.
*More than 50 % pain relief after diagnostic injection with local anesthetic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patient refusal to do the procedure or to share in the study.
*Focal Neurologic Signs.
*Significant anticoagulation e.g.clopedogril(low-dose aspirin will be excluded).
*Pregnancy, breast feeding or planning on becoming pregnant during the trial.
*Infection at the intended injection site.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be under one of the two procedures according to the randomization. All patients will do the procedure under fluoroscopic guidance with use of Cosman RF generator G4TM, 20 gauge curved sharp cannula, 10 cm shaft,
10 mm tip and 10 cm electrodes (Cosman autoclavable CSK-TC10).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly divided in two groups. There will be a box with
60 closed envelopes divided randomly into two groups with 30 envelops in each group. On arrival to theatre, one of the envelopes will be opened and the assigned method will be applied.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analyses will be performed using a standard statistical program (Sigma stat 3.5, Systat Software, San Jose, CA). Sample size is determined by using PASS softwarew for sample size and power calculations.
A difference of 3 or more in the VAS score between the treatment and the control group was considered clinically relevant and a sample size (power=90% and a=0.05) of 25 patients per group was calculated (two sample t-test). To correct for failed blocks and patient drop out, 30 patients per group were included in the study. Demographic data will be analysed using Student’s t-test or Fisher’s exact test. The data will be tested for normality using the Kolmogorov-Smirnov normality test. Repeated measurements
(pain scores, time consumed) will be analyzed by repeated measures analysis of variance if normally distributedwith further paired comparisons at each time interval performed using the t-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2015
Actual
3/02/2015
Date of last participant enrolment
Anticipated
4/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6664 0
Bahrain
State/province [1] 6664 0

Funding & Sponsors
Funding source category [1] 290754 0
Self funded/Unfunded
Name [1] 290754 0
Country [1] 290754 0
Primary sponsor type
Hospital
Name
king Hamad university hospital
Address
Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain.
Country
Bahrain
Secondary sponsor category [1] 289440 0
None
Name [1] 289440 0
Address [1] 289440 0
Country [1] 289440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292386 0
Research and Ethics Committee King Hamad University Hospital.
Ethics committee address [1] 292386 0
Ethics committee country [1] 292386 0
Bahrain
Date submitted for ethics approval [1] 292386 0
Approval date [1] 292386 0
29/01/2015
Ethics approval number [1] 292386 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54778 0
Dr mohamed mourad ibrahim hashim
Address 54778 0
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain.
Country 54778 0
Bahrain
Phone 54778 0
+97333312317
Fax 54778 0
Email 54778 0
[email protected]
Contact person for public queries
Name 54779 0
mohamed mourad ibrahim hashim
Address 54779 0
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain.
Country 54779 0
Bahrain
Phone 54779 0
+97333312317
Fax 54779 0
Email 54779 0
[email protected]
Contact person for scientific queries
Name 54780 0
mohamed mourad ibrahim hashim
Address 54780 0
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain.
Country 54780 0
Bahrain
Phone 54780 0
+97333312317
Fax 54780 0
Email 54780 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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