Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000171011
Ethics application status
Not yet submitted
Date submitted
9/02/2010
Date registered
22/02/2010
Date last updated
22/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcutaneous Pulse Radiofrequency (PRF) Treatment For Shoulder Pain
Scientific title
Transcutaneous Pulse Radiofrequency (PRF)Treatment For Shoulder Pain in Waiting list patients for non-stabilisation shoulder surgery
Secondary ID [1] 1425 0
nil
Universal Trial Number (UTN)
U1111-1113-5982
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 256790 0
Condition category
Condition code
Musculoskeletal 256937 256937 0 0
Other muscular and skeletal disorders
Anaesthesiology 257003 257003 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double Blind Randomised Control Trial of a single Active (6x two-minute 10ms 5pps 80V in one treatment session) and a single Inactive (6x two-minute 0V in one treatment session) Transcutaneous Pulse Radiofrequency Treatment For Shoulder Pain in patients awaiting non-stabilisation shoulder surgery that takes about 15 minutes to perform. There is a gap of about 30 seconds between the 6 treatments which is the time to reposition the two topical self-adhesive electrodes. Transcutaneous PRF is a non-invasive, non-destructive, needle-free treatment that applies a precisely targeted pulsing electrical field around the target nerve that ‘stuns’ rather than destroys the nerve and making the nerve incapable of transmitting pain signals. Although it is not known how transcutaneous PRF works, 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 was a good response to the first transcutaneous PRF.
Intervention code [1] 255995 0
Treatment: Devices
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 257816 0
Visual analogue pain score 0-100
Timepoint [1] 257816 0
Baseline, 1, 3 and 6 months.
Secondary outcome [1] 263232 0
Oxford Shoulder Score
Timepoint [1] 263232 0
Baseline, 1, 3 and 6 months.
Secondary outcome [2] 263233 0
Ability to perform 4 desired tasks previously limited by pain
Timepoint [2] 263233 0
Baseline, 1, 3 and 6 months.
Secondary outcome [3] 263234 0
Medication usage will be assessed by number of tablets per day for pain and medication quantification scale. Perceived need for more treatment is asked a yes/no question do you need more pain relief to do your normal activties.
Timepoint [3] 263234 0
Baseline, 1, 3 and 6 months.

Eligibility
Key inclusion criteria
Waiting list patients for non-stabilisation shoulder surgery with primary complaint of shoulder pain.
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 stabilisation shoulder surgery or complaints of ipsilateral neck, arm or hand pain. 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 using a computerised randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
the patients and assessors will be blinded
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2572 0
3199
Recruitment postcode(s) [2] 2573 0
3930
Recruitment postcode(s) [3] 2574 0
3931
Recruitment postcode(s) [4] 2575 0
3910
Recruitment postcode(s) [5] 2576 0
3200
Recruitment postcode(s) [6] 2577 0
3915
Recruitment postcode(s) [7] 2578 0
3939

Funding & Sponsors
Funding source category [1] 256499 0
Hospital
Name [1] 256499 0
Frankston Hospital
Country [1] 256499 0
Australia
Primary sponsor type
Individual
Name
Dr Murray Taverner
Address
PO Box 52
Frankston, Vic 3199
Country
Australia
Secondary sponsor category [1] 255810 0
Individual
Name [1] 255810 0
A/Prof Terence Loughnan
Address [1] 255810 0
PO Box 52
Frankston, Vic 3199
Country [1] 255810 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258546 0
Frankston Hospital
Ethics committee address [1] 258546 0
PO Box 52
Frankston, Vic 3199
Ethics committee country [1] 258546 0
Australia
Date submitted for ethics approval [1] 258546 0
05/02/2010
Approval date [1] 258546 0
Ethics approval number [1] 258546 0
tba

Summary
Brief summary
The aim of this follow-on study is to determine if transcutaneous pulsed radiofrequency treatment (PRFT) can reduce shoulder pain and if multiple treatments are better than one.
Shoulder pain is third most common musculoskeletal problem in the general population and accounts for 5% of general practitioner musculoskeletal consults. The incidence of shoulder pain is 6.6 to 25 cases per 1000 patients, with a peak incidence in the fourth through sixth decades.
Favourable outcomes have been reported from case series of transcutaneous PRFT described in conference proceedings and the literature. Our earlier double blind “active” versus “sham” study of 2 Hz 20ms 80V transcutaneous PRFT(ACTRN12609000146291) reduced knee pain by 30% at 1 month.
Transcutaneous PRFT is a painless, non-invasive, non-destructive, needle-free treatment that applies a pulsing electrical field around the target nerve using surface mounted electrodes to ‘stun’ rather than destroy the nerves, rendering the nerve incapable of transmitting pain signals. It is not known how transcutaneous PRFT 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 PRFT.
50 patients referred to Frankston Hospital for non-stabilisation surgery for shoulder pain will be invited to participate in a double blind randomised placebo controlled (DBRPC) trial of transcutaneous PRFT. Patients with an unstable shoulder or 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 PRFT self-report of pain intensity, global satisfaction, medication use and Oxford Shoulder Score questionnaire.
Trial website
n/a
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30824 0
Address 30824 0
Country 30824 0
Phone 30824 0
Fax 30824 0
Email 30824 0
Contact person for public queries
Name 14071 0
Dr Murray Taverner
Address 14071 0
Frankston Hospital
PO Box 52
Frankston, Victoria, 3199
Country 14071 0
Australia
Phone 14071 0
+61 3 9874 7250
Fax 14071 0
+61 3 9784 7567
Email 14071 0
[email protected]
Contact person for scientific queries
Name 4999 0
Dr Murray Taverner
Address 4999 0
Frankston Hospital
PO Box 52
Frankston, Victoria, 3199
Country 4999 0
Australia
Phone 4999 0
+61 3 9874 7250
Fax 4999 0
+61 3 9784 7567
Email 4999 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
No additional documents have been identified.