Testosterone to treat men with painful osteoarthritis of the knee

Study type A pilot randomised controlled trial (RCT) to test whether addition of testosterone to usual care (exercise rehabilitative program) will improve function, pain and muscle strength in N=30 men with significant knee OA. The trial will be conducted in fully double-blind fashion with a 12 week duration. Randomisation will be completed by Lawley pharmaceuticals. Outcomes will be addressed at baseline (week 0) and end-of study (week 12) Procedures Medical assessments will be performed at IIID (Murdoch University) By Tarryn Sohn (medical registrar) with supervision from Dr Helen Keen (rheumatologist), Prof Bu Yeap (endocrinologist), Merrilee Needham (neurologist) Drugs applied Active name: testosterone Trade name: AndroForte 5, transdermal cream, 100mg in 2 mls applied once daily by the patient over a 12 week period Placebo: the placebo contains exactly the same ingredients as the active (minus the testosterone) exercise training The exercise program will comprise 5 supervised sessions (1 hour each) within Murdoch Universities’ gymnasium over the 12 week period, and a supervised home-based exercise program. Exercise training The exercise program will be individually prescribed and progressed to accommodate the large variance in functional capabilities of each participant expected at baseline and in their individual exercise-response. Training variables will be modified according to exercise type, duration, frequency (based on pain and recovery) and intensity of the exercise. Resistance exercise will largely be conducted using multi-joint compound exercises of the lower limbs using body-weight and elastic bands (Therabands); with varying levels of resistance providing the different intensities (different colour bands). The initial exercise prescription will occur following baseline assessment. Progression of exercises and intensity will be based on rating of perceived exertion (RPE; a subjective scale) scores provided during fortnightly telephone calls and supervisory visits. Home-based program The Home-based progressive exercise will comprise of resistance, aerobic/ mobility, and balance exercises. All exercises will comprise of either resistance bands (therabands) or body weight movements. Resistance bands will largely be single-joint exercises while body weight movements will target movements involved in mobility and function, however focus will be on knee extensors and stabilisers. This will be supplemented with aerobic/ mobility and functional exercises (i.e. walking, sitting and rising) and balance exercises (ie narrow stance, tandem stance). The duration of the exercise program will be approximately 30 minutes which will be completed at least three times a week. The home-based exercise program will be completed only at home by participants for the intervention period. The program will be supervised via telephone and home visits. All exercise sessions will be monitored via an exercise-based log-book which will include information regarding the rating of perceived exertion scale. The participants will be asked to keep a record on a diary of their drug application, exercise and pain levels (using the visual analogue scale prior to exercise session). Additionally, all analgesia used will be recorded in patient’s diaries. Procedure timeline Medical assessments: screening, baseline and end of study Blood collection: screening, week 0 and week 12