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Trial registered on ANZCTR


Registration number
ACTRN12613000549729
Ethics application status
Approved
Date submitted
23/04/2013
Date registered
15/05/2013
Date last updated
17/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Radiofrequency Treatment of Phantom and Residual Limb Pain in Persons with a Lower Limb Amputation: A Randomised Double Blinded Control Trial
Scientific title
Radiofrequency Treatment of Phantom and Residual Limb Pain in Persons with a Lower Limb Amputation: A Randomised Double Blinded Control Trial.
Secondary ID [1] 282391 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phantom and Residual Limb Pain in Persons with a Lower Limb Amputation 288972 0
Condition category
Condition code
Anaesthesiology 289310 289310 0 0
Pain management
Physical Medicine / Rehabilitation 289479 289479 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulsed Radiofrequency Treatment (PRF)
This will be delivered via percutaneous radio frequency needle which will be inserted under ultrasound guidance with the tip positioned next to the neuroma.
PRF will be performed at a frequncy of 2Hz, 20msec pulses in a 1 second cycle of 120 seconds duration at a temperature of 42 C. This will be repeated three times whilst the needle is rotated until a 360 degree area of neuroma is covered.

Before the needle is removed, a 2mL mixture of 1.5mL 1% lignocaine and 0.5mL Celestone will be injected around the neuroma.

The estimated total duration of the procedure will be 30 minutes.

There will be one treatment session.

Intervention code [1] 287024 0
Treatment: Devices
Comparator / control treatment
Same radiofrequency needle will be inserted under ultrasound guidance.

No pulsed radiofrequency will be delivered through the needle.

Before the needle is removed, a 2mL mixture of 1.5mL 1% lignocaine and 0.5mL Celestone will be injected.
Control group
Placebo

Outcomes
Primary outcome [1] 289419 0
Brief Pain Inventory (BPI) including Verbal Numerical Rating Score (VNRS)
Timepoint [1] 289419 0
1 week, 4 weeks, 12 weeks post intervention
Primary outcome [2] 289420 0
Depression Anxiety Stress Scale (DASS)
Timepoint [2] 289420 0
1 week, 4 weeks, 12 weeks post intervention
Primary outcome [3] 289421 0
Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R)
Timepoint [3] 289421 0
1 week, 4 weeks, 12 weeks post intervention
Secondary outcome [1] 302438 0
The Patient Global Expression of Pain (PGIC) Scale
Timepoint [1] 302438 0
1 week, 4 weeks, 12 weeks post intervention
Secondary outcome [2] 302439 0
Short-Form MacGill Pain Questionnaire
Timepoint [2] 302439 0
1 week, 4 weeks, 12 weeks post intervention
Secondary outcome [3] 302780 0
Healthcare Utilisation (Information about medical attendance/s will be asked and recorded)
Timepoint [3] 302780 0
1 week, 4 weeks, 12 weeks post intervention

Eligibility
Key inclusion criteria
Inclusion criteria will be age >18, at least 1 major amputation above the ankle, the presence of persistent residual limb or phantom limb pain for at least 3 months with a peripheral trigger clinically +/- ultrasound (US) confirmation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are previous radiofrequency denervation of neuroma, contraindications to steroid, local anaesthetic and sedative agent administration, bleeding dyscrasias, immunosuppression, concomitant active infection of the procedure site or systemic infection, fragile residual limb skin prone to non-healing and breakdown, and severe cognitive impairment

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)
Sealed opaque envelops will be used for allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to receive percutaneous PRF neurotomy or the same procedure without effective neurotomy using a computer-generated randomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Based on a power of 80% and a two-tailed alpha of 0.05, the sample size required for the present study will be 30 per group for a total of 60 patients to detect a standardised difference of 0.75.

Two-way repeated measures analysis of variance (ANOVA) with Tukey tests for multiple comparisons will be used to compare the changes from baseline VNRS pain scores among baseline, post-procedure 1, 4, and 12 weeks. To compare the differences of VAS pain scores and satisfaction between groups, the Mann–Whitney U test will be used at each time point. To compare patients’ characteristics variables,
the Fisher’s exact test will be used for sex, treatment sites. The unpaired t-test will be used for body weight, height, body mass index, duration. Data analysis will be performed using SPSS 11.0 for window (SPSS Inc) on a personal computer. Values will be estimated as mean +/- standard deviation. A P value of <0.05 will be taken to indicate a significant difference.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 944 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 945 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [3] 946 0
Western Hospital - Footscray
Recruitment postcode(s) [1] 6798 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 6799 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 287163 0
Hospital
Name [1] 287163 0
The Royal Melbourne Hospital
Address [1] 287163 0
Grattan Street
Parkville, VIC
3050
Country [1] 287163 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Grattan Street
Parkville
VIC 3050
Country
Australia
Secondary sponsor category [1] 285930 0
None
Name [1] 285930 0
Address [1] 285930 0
Country [1] 285930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289160 0
Melbourne Health
Ethics committee address [1] 289160 0
Grattan Street
Parkville, VIC
3050
Ethics committee country [1] 289160 0
Australia
Date submitted for ethics approval [1] 289160 0
Approval date [1] 289160 0
04/12/2012
Ethics approval number [1] 289160 0
2012.090

Summary
Brief summary
Multicentre randomised double-blinded sham-lesion control trial to evaluate the role and effectiveness of pulsed radiofrequency treatment (PRF) of a peripheral nociceptive trigger (i.e. neuroma) in the management of phantom and residual limb pain.
Participants will be recruited through the Victorian Artificial Limb Program Outpatient Clinic at Royal Park Campus RMH.

Eligible patients will undergo perineuromal injections with local anaesthetic performed under ultrasound. Responses will be recorded as positive if the participant experiences a decrease in pain intensity of at least 50%.
Patients with a positive response will proceed to PRF or placebo assigned in a random manner.
Participants will be followed up at 1 week, 4 weeks and 3 months.
Measures of pain intensity (BPI), pain quality (SF MacGill Pain Questionaire), physical functioning (BPI), emotional functioning (DASS), patients global rating of improvement and satisfaction (PGIC), health-related quality of life, prosthetic use (TAPES-R), healthcare utilisation will be obtained at each review.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39530 0
Dr Kevin Young
Address 39530 0
Royal Park Campus, Royal Melbourne Hospital
34-54 Poplar Rd
Parkville, VIC 3052, Australia
Country 39530 0
Australia
Phone 39530 0
+61 3 8387 2194
Fax 39530 0
Email 39530 0
kevin.young@mh.org.au
Contact person for public queries
Name 39531 0
Dr Kevin Young
Address 39531 0
Royal Park Campus, Royal Melbourne Hospital
34-54 Poplar Rd
Parkville, VIC 3052, Australia
Country 39531 0
Australia
Phone 39531 0
+61 3 8387 2194
Fax 39531 0
Email 39531 0
kevin.young@mh.org.au
Contact person for scientific queries
Name 39532 0
Dr Kevin Young
Address 39532 0
Royal Park Campus, Royal Melbourne Hospital
34-54 Poplar Rd
Parkville, VIC 3052, Australia
Country 39532 0
Australia
Phone 39532 0
+61 3 8387 2194
Fax 39532 0
Email 39532 0
kevin.young@mh.org.au

No information has been provided regarding IPD availability
Summary results
No Results