None listed
Conditions
Brief summary
Knee osteoarthritis causes persistent pain and difficulty in daily activities. Although exercise is the cornerstone of conservative treatment for knee osteoarthritis, its effects are, at best, moderate. We aim to conduct a ‘proof of concept’ study to explore the use of a novel intervention combining non-invasive brain stimulation and exercise therapy in people with knee osteoarthritis. We hypothesise that this intervention will have a greater effect on the biological mechanisms that contribute to persistent pain and disability in knee osteoarthritis, and therefore provide greater benefits than exercise therapy alone.
Interventions
Repetitive transcranial magnetic stimulation (rTMS) and quadriceps strengthening exercise. Participants will receive a total of 12 treatment sessions (two sessions per week for six weeks). A qualified and registered physiotherapist with clinical experience in treating knee osteoarthritis will provide exercise therapy. Physiotherapist provides exercise intervention will be blinded to group allocation. For each session, participants will receive active rTMS (15 minutes) followed by supervised exer
Repetitive transcranial magnetic stimulation (rTMS) and quadriceps strengthening exercise. Participants will receive a total of 12 treatment sessions (two sessions per week for six weeks). A qualified and registered physiotherapist with clinical experience in treating knee osteoarthritis will provide exercise therapy. Physiotherapist provides exercise intervention will be blinded to group allocation. For each session, participants will receive active rTMS (15 minutes) followed by supervised exercise (30 minutes). For active rTMS, high-frequency rTMS will be applied to the motor cortical hotspot of the rectus femoris of the most painful knee using a Magstim Super Rapid2 and a figure-of-eight coil. This TMS machinery is registered on the Australian Register of Therapeutic Goods. For each session, 3000 stimuli (10 Hz, 30 trains of 10 seconds, 20-second intertrain interval) will be delivered at 90% of resting motor threshold. The resting motor threshold will be determined at the beginning of each treatment session. For exercise, one-to-one quadriceps strengthening exercise will be delivered by the physiotherapist blind to participants’ group allocation to all participants. A standardised set of quadriceps strengthening exercises known to be effective in knee osteoarthritis will be performed using ankle cuff weights or resistance bands. Examples of exercises include seated knee extension, hip abductor strengthening wall squats, sit-to-stand and steps. Exercise intensity will be progressed by the physical therapist as appropriate for each participant. The adherence to the supervised exercise sessions will be monitored using a treatment attendance checklist. The physiotherapist will also develop, monitor and progress a home exercise program that participants will be instructed to perform four times a week during intervention. Each home exercise session will last for 30 minutes. Participants will complete an exercise diary and return to the treating physiotherapist weekly for compliance and adherence to their home exercise program. Any adverse effects of home exercise will be recorded on the exercise diary.
Sponsors
Neuroscience Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals aged equal or older than 50 years with knee osteoarthritis based on the American College of Rheumatology Clinical Criteria (at least one of the following items: stiffness less than 30 minutes, crepitus, bony tenderness, bony enlargement, no palpable warmth). 2. Knee pain for at least 3 months and on most days of the past month. 3. Average pain intensity equal or greater than 4 on an 11-point numeric rating scale in the past week.
Exclusion criteria
1. Previous knee joint replacement or high tibial osteotomy. 2. Knee surgery or joint injection in past six months. 3. Planned surgery in the next nine months. 4. Current or past four weeks oral corticosteroids use. 5. Systemic arthritis. 6. Previous knee fracture or malignancy. 7. Other condition affecting lower limb function. 8. Participation in knee strengthening exercise in past six months. 9. Loss of sensation of the affected lower limb. 10. Neurological or psychiatric disorders. 11. Use of neuroactive drugs. 12. Contraindications to TMS (i.e., epilepsy, metal implant in the skull) based on the TMS safety screening questionnaire.
Outcome results
None listed