None listed
Conditions
Brief summary
Osteoarthritis (OA) affects more than 20% of Australians aged over 55. The knee joint is commonly affected, resulting in knee pain and difficulty with everyday tasks such as walking or climbing stairs. Current treatments (e.g. medication, surgery, exercise) are only partially effective. Novel therapies that optimize the effects of current treatments are needed to reduce the social and economic burden on sufferers, caregivers and the wider community. Here we aim to conduct a ‘proof of concept’ study to investigate the use of an innovative non-invasive brain stimulation treatment to bolster the effects of exercise therapy in knee OA. We anticipate that the combination of non-invasive brain stimulation and exercise will have a greater effect on the biological mechanisms that contribute to pain, and thus provide greater benefits for pain and disability, than exercise alone.
Interventions
Participants will receive 20 minutes of active transcranial direct current stimulation (tDCS) immediately prior to exercise therapy 2 x per week for 8 weeks. The intervention will be delivered by a qualified physiotherapist trained in the use of tDCS. Participants will also complete home exercises 2 x per week to mimic typical clinical practice. Adherence to the home exercise program will be monitored using a log book.
Transcranial direct current stimulation (tDCS): will be delivered using a
Participants will receive 20 minutes of active transcranial direct current stimulation (tDCS) immediately prior to exercise therapy 2 x per week for 8 weeks. The intervention will be delivered by a qualified physiotherapist trained in the use of tDCS. Participants will also complete home exercises 2 x per week to mimic typical clinical practice. Adherence to the home exercise program will be monitored using a log book. Transcranial direct current stimulation (tDCS): will be delivered using a direct current stimulator via two 35 cm2 surface sponge electrodes. The active electrode (anode) will be placed over the primary motor cortex and the reference electrode (cathode) over the contralateral supraorbital region. Current intensity will be ramped up (0 mA to 1 mA) and down (1 mA to 0 mA) over 10 s at the beginning and end of the stimulation period. For the remainder of the 20 minute treatment, current intensity will be consistent at 1mA. Exercise: Quadriceps strengthening exercises will be performed with ankle cuff weights or elastic bands for resistance where necessary. Exercise intensity will be progressed by the physiotherapist as appropriate for each participant. Each session will last 30 minutes. A home exercise plan will be developed, monitored and progressed by the physiotherapist for each participant.
Sponsors
Dr Siobhan Schabrun
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants with knee OA (American College of Rheumatology criteria) will be recruited from the community. A minimum pain score of 40 on a 100 mm visual analogue scale (VAS) will be required.
Exclusion criteria
The main exclusion criteria are: (i) intra-articular corticosteroid injection or knee surgery in the past 6 months; (ii) systemic arthritic conditions; (iii) knee joint replacement or high tibial osteotomy; (iv) other muscular, joint or neurological conditions affecting lower limb function; (v) unable to walk unaided; (vi) currently undertaking a structured exercise program for knee OA or (vii) contraindications to tDCS (e.g. epilepsy) or central pain modulation techniques (e.g. loss of sensation).
Outcome results
None listed