Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000351415
Ethics application status
Approved
Date submitted
10/06/2007
Date registered
29/06/2007
Date last updated
29/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcutaneous Pulse Radiofrequency Treatment for Knee Pain
Scientific title
Transcutaneous 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 osteoarthritis 1908 0
Condition category
Condition code
Musculoskeletal 1999 1999 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double Blind Randomised Control Trial of Active (5 two-minute 20ms 2Hz 80V in one treatment session) and Inactive (5 two-minute 0V in one treatment session) Transcutaneous Pulse Radiofrequency Treatment For Knee Pain in patients awaiting knee replacement surgery.
Intervention code [1] 1819 0
Treatment: Devices
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 2821 0
VAS 0-100 pain score
Timepoint [1] 2821 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [1] 4754 0
Brief Pain Inventory (BPI),
Timepoint [1] 4754 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [2] 4755 0
Ability to perform 4 desired tasks previously limited by pain,
Timepoint [2] 4755 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [3] 4756 0
Pain Self-Efficacy questionnaire,
Timepoint [3] 4756 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [4] 4757 0
MOS Short Form-36, Knee injury
Timepoint [4] 4757 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [5] 4758 0
Osteoarthritis Outcome Scale (KOOS) questionnaire
Timepoint [5] 4758 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [6] 4759 0
Global Treatment Satisfaction score,
Timepoint [6] 4759 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [7] 4760 0
Medication usage and perceived need for more treatment.
Timepoint [7] 4760 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [8] 4761 0
Range of movement measured with a goniometer,
Timepoint [8] 4761 0
Baseline, 1 week, 1, 3, 6 and 12 months
Secondary outcome [9] 4762 0
'Timed chair stands, 20m and 400m walks.
Timepoint [9] 4762 0
Baseline, 1 week, 1, 3, 6 and 12 months

Eligibility
Key inclusion criteria
Waiting list patients with painful knee(s) rated >=5/10 on a verbal rating scale awaiting knee arthroplasty.
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, or with ipsilateral hip or ankle pain interfering with walking.Subject has terminal cancer, is unable to communicate or refuses to participate.

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 envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The patients and assessors will be blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2140 0
University
Name [1] 2140 0
Grant from Frankston Hospital
Country [1] 2140 0
Australia
Primary sponsor type
Individual
Name
Dr Murray Taverner
Address
Country
Secondary sponsor category [1] 1944 0
Individual
Name [1] 1944 0
Dr Terence Loughnan
Address [1] 1944 0
Country [1] 1944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3936 0
Frankston Hospital
Ethics committee address [1] 3936 0
Ethics committee country [1] 3936 0
Australia
Date submitted for ethics approval [1] 3936 0
Approval date [1] 3936 0
Ethics approval number [1] 3936 0
2007-24

Summary
Brief summary
The aim of this follow-on study is to determine if a transcutaneous pulse radiofrequency treatment can provide useful pain relief in patients with complex knee pain awaiting knee arthroplasty.
Knee pain is a common problem with 19-23% prevalence in people aged between 40 and 79 years. An earlier study has shown some patients awaiting knee replacement surgery obtain good pain relief and functional improvement from selective nerve blocks lasting several weeks or months. This however still leaves a significant number of patients experiencing pain while waiting for surgery and other strategies need to be explored.
Favourable outcomes have been reported from case series of transcutaneous pulse radiofrequency treatment described in conference proceedings and the literature. Transcutaneous PRF is a painless, non-invasive, non-destructive, needle-free alternative treatment that applies a pulsing electrical field around the target nerve using TENS electrodes that ‘stuns’ rather than destroys the nerve, rendering the nerve incapable of transmitting pain signals.
It is not known how transcutaneous PRF works, however, it is thought to induce long lasting biochemical changes in the target spinal nerves without disrupting sensation or motor function. Treatment can be repeated if there is a good response to the first transcutaneous PRF.
40 knee arthroplasty waiting list patients rating their knee pain =5/10 on a verbal rating scale will be invited to participate in a DBRPC trial of transcutaneous pulse radiofrequency treatment. Patients with awaiting a revision hip replacement, with hip or ankle pain interfering with walking, terminal cancer, unable to communicate in English or don’t want to participate will be excluded.
The outcome will be determined by comparing pre and post transcutaneous pulse radiofrequency treatment self report questionnaires and objective physical measures
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27633 0
Address 27633 0
Country 27633 0
Phone 27633 0
Fax 27633 0
Email 27633 0
Contact person for public queries
Name 11008 0
Dr Murray Taverner
Address 11008 0
Department of Medicine
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 11008 0
Australia
Phone 11008 0
+61 3 97847777
Fax 11008 0
+61 3 97847441
Email 11008 0
mtaverner@phcn.vic.gov.au
Contact person for scientific queries
Name 1936 0
Dr Murray Taverner
Address 1936 0
Department of Medicine
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 1936 0
Australia
Phone 1936 0
+61 3 97847777
Fax 1936 0
+61 3 97847441
Email 1936 0
mtaverner@phcn.vic.gov.au

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
No additional documents have been identified.