Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000146291
Ethics application status
Approved
Date submitted
21/08/2007
Date registered
12/03/2009
Date last updated
12/03/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Percutaneous Pulse radiofrequency treatment for knee pain
Scientific title
Percutaneous Pulse radiofrequency treatment to relieve pain of knee osteoarthritis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee pain 2250 0
Condition category
Condition code
Musculoskeletal 2341 2341 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open label follow-on pilot study of percutaneous Pulse radiofrequency treatment to relieve knee pain in patients awaiting knee replacement surgery that obtained temporary pain relief from selective nerve blocks to the knee. The treatment involves performing 2 120s or 240 pulse dose 45 volt 2 Hz 20 millisecond pulse radiofrequency treatments to each tender cutaneous nerve branch around the knee with a 10mm 20g active tip electrode.
Intervention code [1] 1962 0
Treatment: Devices
Comparator / control treatment
Patient pre and post treatment comparison
Control group
Historical

Outcomes
Primary outcome [1] 3235 0
Visual Analogue Pain Scale (VAPS) 0-100 pain score
Timepoint [1] 3235 0
Baseline, 1 hour, 1 week, 1, 3 and 6 months
Secondary outcome [1] 5399 0
Brief pain inventory
Timepoint [1] 5399 0
Baseline, 1 week, 1, 3 and 6 months
Secondary outcome [2] 5400 0
Timed 5 chair stands, 20m and 400m walks
Timepoint [2] 5400 0
Baseline, 1 hour, 1 week, 1, 3 and 6 months
Secondary outcome [3] 5401 0
knee osteoarthritis outcome score (KOOS)
Timepoint [3] 5401 0
Baseline, 1 week, 1, 3 and 6 months
Secondary outcome [4] 5402 0
Medical Outcome Survey (36) short form (MOS SF36)
Timepoint [4] 5402 0
Baseline, 1 week, 1, 3 and 6 months
Secondary outcome [5] 5403 0
Pain self efficacy questionnaire score
Timepoint [5] 5403 0
Baseline, 1 hour, 1 week, 1, 3 and 6 months

Eligibility
Key inclusion criteria
Waiting list patients with painful knees rated >=5/10 on a verbal rating scale awaiting knee arthroplasty, who obtained temporary pain relief from the selective nerve block with lignocaine or N-saline in a preceding DBRPCT study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject on waiting list for a revision knee replacement, Subject has terminal cancer, is unable to communicate or refuses to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Waiting list patients with painful knees rated >=5/10 on a verbal rating scale awaiting knee arthroplasty, who obtained temporary pain relief from the selective nerve block with lignocaine or N-saline in a preceding DBRPCT study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 384 0
3199
Recruitment postcode(s) [2] 385 0
3930
Recruitment postcode(s) [3] 386 0
3910
Recruitment postcode(s) [4] 387 0
3931
Recruitment postcode(s) [5] 388 0
3197
Recruitment postcode(s) [6] 389 0
3915
Recruitment postcode(s) [7] 390 0
3934

Funding & Sponsors
Funding source category [1] 2538 0
Hospital
Name [1] 2538 0
Frankston Hospital
Country [1] 2538 0
Australia
Primary sponsor type
Individual
Name
Dr Murray Taverner
Address
Frankston Hospital
PO Box 52
Frankston, 3199
Country
Australia
Secondary sponsor category [1] 2296 0
Individual
Name [1] 2296 0
Dr Terence Loughnan
Address [1] 2296 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country [1] 2296 0
Australia
Other collaborator category [1] 16 0
Individual
Name [1] 16 0
Dr Ashley Webb
Address [1] 16 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country [1] 16 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4456 0
Frankston Hospital
Ethics committee address [1] 4456 0
Frankston Hospital
PO Box 52
Frankston, 3199
Ethics committee country [1] 4456 0
Australia
Date submitted for ethics approval [1] 4456 0
Approval date [1] 4456 0
07/08/2006
Ethics approval number [1] 4456 0
2006-21

Summary
Brief summary
Knee pain is a common problem with 19-23% prevalence in people aged 40 and over. Frankston hospital has 138 patients awaiting knee replacement and a waiting time exceeding 18 months. Preliminary work suggest patient with anterior, medial and lateral compartment knee pain who have not had open knee surgery may obtain good but temporary pain relief and functional improvement from selectively anaesthetising the cutaneous nerves supplying the knee joint. This study seeks to validate the injection technique, determine which nerves need to be injected and which patients, pain patterns and pathology may benefit from this treatment or may benefit from a follow-on study of pulse radiofrequency treatment to these nerves.
Trial website
Trial related presentations / publications
• Taverner, MG, Loughnan, TE. A pilot study comparing three pulsed radiofrequency treatment techniques for knee pain in patients awaiting knee replacement. ANZCA/FPM, Annual Scientific Meeting. Sydney 2/5/2008. Pain Medicine. 9(6):763-764, September 2008
Public notes

Contacts
Principal investigator
Name 27980 0
Address 27980 0
Country 27980 0
Phone 27980 0
Fax 27980 0
Email 27980 0
Contact person for public queries
Name 11137 0
Dr Murray Taverner
Address 11137 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country 11137 0
Australia
Phone 11137 0
03 9784 7445
Fax 11137 0
03 9784 7441
Email 11137 0
[email protected]
Contact person for scientific queries
Name 2065 0
Dr Murray Taverner
Address 2065 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country 2065 0
Australia
Phone 2065 0
03 9784 7445
Fax 2065 0
03 9784 7441
Email 2065 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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