Fary 2008.

Trial name or title	ACTRNI2607000492459
Methods	Double‐blind, randomised placebo‐controlled trial Randomisation method: computer‐generated block randomisation with stratification for gender, age and intensity of pain Concealment of allocation: by independent administrator Blinding: patients, those administering treatment/s, those assessing outcomes, those analysing results/data Sample size calculation: reported Analyses based on intention‐to‐treat principle Trial duration: 26 weeks Sponsored by: non‐profit organisation Arthritis Australia and Physiotherapy Research Foundation
Participants	70 patients with primary knee OA to be randomised Study joints: 70 knees Selection criteria: persistent, stable pain for minimum of 3 months, at least 25 mm on a 100 mm VAS
Interventions	Experimental intervention: pulsed electrostimulation, daily Control intervention: sham pulsed electrostimulation, daily Duration of treatment period: 26 weeks Analgesics allowed and measured with diary Device: Metron Digi‐10s, adapted by engineer Self‐administered: yes Waveform: pulsed, exponentially declining Pulse width: not reported Pulse frequency: 100 Hz Amplitude: below sensory threshold Duration of stimulation: minimally 7 hours per day Electrodes: not reported Electrode placement: not reported Sham device: identical in appearance
Outcomes	Primary outcomes: conflicting information reported in Australian/New Zealand clinical trial register (ANZCTR) and subsequent publication in BMC. In ANZCR reported as pain on VAS, in BMC more than 2 primary outcomes are reported; pain (VAS and WOMAC), function (WOMAC), and patient global assessment (VAS). Main time points of interest are reported consistently as baseline, 4, 16 and 26 weeks. Secondary outcomes: in ANZCTR reported as function (WOMAC) and patient global assessment (VAS); in BMC reported as stiffness (WOMAC 3.1), quality of life (SF‐36), global perceived effect scale (GPES), physical activity (Human Activity Profile (HAP) questionnaire plus accelerometers Safety outcomes: in BMC, the recording of adverse events was reported
Starting date	26th of September 2007
Contact information	Robyn E Fary Curtin University of Technology, School of Physiotherapy, Kent Street, Bentley, WA, 6102, Australia Tel: 08 9266 3667 Email: R.Fary@curtin.edu.au
Notes	Status at 17 July 2009: open to recruitment