Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000492459
Ethics application status
Approved
Date submitted
23/09/2007
Date registered
24/09/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating the effectiveness of pulsed electrical stimulation in treating osteoarthritis of the knee
Scientific title
A randomised placebo-controlled trial to determine the effectiveness of pulsed electrical stimulation (E-PES) in the management of osteoarthritis of the knee as measured by changes in pain, function and patient global assessment.
Universal Trial Number (UTN)
Trial acronym
E-PES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ostearthritis of the knee 2388 0
Condition category
Condition code
Musculoskeletal 2492 2492 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two group double-blind, randomised, placebo-controlled, repeated measures trial will be conducted to investigate the effectiveness of pulsed electrical stimulation (PES) in the management of people with osteoarthritis of the knee over a 26 week period. Subjects in both the intervention and placebo groups will be asked to use the transcutaneously applied PES and placebo-PES respectively at sub-sensory levels for a minimum of seven hours per day (overnight recommended) during the study period. All subjects will be able to continue their usual arthritis management throughout the trial period.
Intervention code [1] 2114 0
Treatment: Other
Comparator / control treatment
Placebo pulsed electrical stimulation
Control group
Placebo

Outcomes
Primary outcome [1] 3389 0
Pain (100 mm visual analogue scale)
Timepoint [1] 3389 0
Baseline, four, 16 and 26 weeks.
Secondary outcome [1] 5623 0
Patient global assessment (100 mm visual analogue scale)
Timepoint [1] 5623 0
Baseline, four, 16 and 26 weeks
Secondary outcome [2] 5624 0
Function (Western Ontario and McMaster Universities Osteoarthritis Index)
Timepoint [2] 5624 0
Baseline, four, 16 and 26 weeks

Eligibility
Key inclusion criteria
Primary knee osteoarthritis diagnosed using the American College of Rheumatology modified clinical classification criteria; persistent, stable pain for a minimum of three months; pain score of at least 25mm on a 100mm visual analogue scale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-existing inflammatory arthropathies, contraindications to electrical stimulation, existence of skin disorders in the area of the knee to be treated, scheduled to have a knee joint replacement during the study period, unable to read or understand English

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)
Initial phone screening followed by final screening to ensure study criteria are met. Written informed consent gained, Stratification details sent to a person independent of the study for group allocation using computer software. Equipment allocated to subjects by serial number to maintain blinding of groups to all investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation (age, gender and initial pain score). Permuted block allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2641 0
Charities/Societies/Foundations
Name [1] 2641 0
Arthritis Australia
Country [1] 2641 0
Australia
Funding source category [2] 2642 0
Charities/Societies/Foundations
Name [2] 2642 0
Physiotherapy Research Foundation
Country [2] 2642 0
Australia
Primary sponsor type
Individual
Name
Robyn Fary
Address
Curtin University of Technology
School of Physiotherapy
Kent Street
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 2389 0
Individual
Name [1] 2389 0
Dr N K Briffa
Address [1] 2389 0
Curtin University of Technology
School of Physiotherapy
Kent Street
Bentley WA 6102
Country [1] 2389 0
Australia
Secondary sponsor category [2] 2390 0
University
Name [2] 2390 0
Curtin University of Technology
Address [2] 2390 0
Kent Street
Bentley WA 6102
Country [2] 2390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4559 0
Curtin University of Technology Human Research Ethics Committee
Ethics committee address [1] 4559 0
Kent Street
Bentley WA 6102
Ethics committee country [1] 4559 0
Australia
Date submitted for ethics approval [1] 4559 0
Approval date [1] 4559 0
13/12/2006
Ethics approval number [1] 4559 0
HR 122/2006

Summary
Brief summary
The primary purpose of this study is to determine whether PES is an effective treatment choice for people with osteoarthritis of the knee. The hypothesis is that PES will produce a clinically important and sustained improvement in pain, function, patient global assessment, quality of life and physical activity when compared with placebo treatment in individuals with osteoarthritis of the knee.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28064 0
Address 28064 0
Country 28064 0
Phone 28064 0
Fax 28064 0
Email 28064 0
Contact person for public queries
Name 11221 0
Robyn Fary
Address 11221 0
Curtin University of Technology
School of Physiotherapy
Kent Street
Bentley WA 6102
Country 11221 0
Australia
Phone 11221 0
08 9266 3667
Fax 11221 0
Email 11221 0
[email protected]
Contact person for scientific queries
Name 2149 0
Robyn Fary
Address 2149 0
Curtin University of Technology
School of Physiotherapy
Kent Street
Bentley WA 6102
Country 2149 0
Australia
Phone 2149 0
08 9266 3667
Fax 2149 0
Email 2149 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of pulsed electrical stimulation in the treatment of osteoarthritis of the knee: A randomized controlled trial.2009https://dx.doi.org/10.1002/art.25926
N.B. These documents automatically identified may not have been verified by the study sponsor.