ANZCTR - Registration

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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

Condition category

Condition code

Musculoskeletal

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]

Treatment: Devices

Comparator / control treatment

Control group

Placebo

Outcomes

Primary outcome [1]

VAS 0-100 pain score

Timepoint [1]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [1]

Brief Pain Inventory (BPI),

Timepoint [1]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [2]

Ability to perform 4 desired tasks previously limited by pain,

Timepoint [2]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [3]

Pain Self-Efficacy questionnaire,

Timepoint [3]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [4]

MOS Short Form-36, Knee injury

Timepoint [4]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [5]

Osteoarthritis Outcome Scale (KOOS) questionnaire

Timepoint [5]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [6]

Global Treatment Satisfaction score,

Timepoint [6]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [7]

Medication usage and perceived need for more treatment.

Timepoint [7]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [8]

Range of movement measured with a goniometer,

Timepoint [8]

Baseline, 1 week, 1, 3, 6 and 12 months

Secondary outcome [9]

'Timed chair stands, 20m and 400m walks.

Timepoint [9]

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]

University

Name [1]

Grant from Frankston Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Murray Taverner

Address

Country

Secondary sponsor category [1]

Individual

Name [1]

Dr Terence Loughnan

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Frankston Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Dr Murray Taverner

Address

Department of Medicine
Frankston Hospital
PO Box 52
Frankston VIC 3199

Country

Australia

Phone

+61 3 97847777

Fax

+61 3 97847441

Email

mtaverner@phcn.vic.gov.au

Contact person for scientific queries

Name

Dr Murray Taverner

Address

Department of Medicine
Frankston Hospital
PO Box 52
Frankston VIC 3199

Country

Australia

Phone

+61 3 97847777

Fax

+61 3 97847441

Email

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.