None listed
Conditions
Brief summary
In our proposed study, all participants will get an exercise program (so all will experience some benefit), but half will get real tDCS to apply at home and half will get sham (‘fake’) tDCS. We will explore whether delivering this intervention at home is feasible and whether it produces any negative or unwanted effects. Critically, we will examine whether home-based tDCS boosts the effects of exercise in treating pain among people with knee OA. If successful, this intervention could lead to further trials and one day provide a more accessible and cost-effective treatment for individuals with knee OA, revolutionising management of this global health concern.
Interventions
Intervention
After baseline assessments (approximately 1 hour), participants will be provided with a lower limb strengthening exercise program (face-to-face and one-on-one with the researcher in the lab). This program will involve a combination of body weight squats, bridges, lunges, and unweighted deadlift exercises. Participants will be familiarised with the exercises during their baseline session by a trained physiotherapist or exercise physiologist and then perform them at home three times p
Intervention After baseline assessments (approximately 1 hour), participants will be provided with a lower limb strengthening exercise program (face-to-face and one-on-one with the researcher in the lab). This program will involve a combination of body weight squats, bridges, lunges, and unweighted deadlift exercises. Participants will be familiarised with the exercises during their baseline session by a trained physiotherapist or exercise physiologist and then perform them at home three times per week (Mondays, Wednesdays, and Fridays). An exercise program duration of 8 weeks has been chosen as this is sufficient to observe improvements in pain intensity At the end of their baseline session, participants will be randomly allocated to receive either: i) active home-based transcranial direct current stimulation (tDCS) + exercise or ii) sham home-based tDCS + exercise. Participants will receive 20 minutes of either active or sham home-based tDCS daily from Monday-Friday during the first 2-weeks of treatment. On days where participants perform their strengthening program, the tDCS intervention will be delivered for 20 minutes immediately before strengthening exercises. Exercise progressions (one-one-one, under the same setting as the initial prescription) will be provided during a follow-up session 4 weeks after baseline assessments. This follow-up session (1 hour) will involve patients attending the lab for follow-up data collection of all outcomes and progression of exercise. Home-based tDCS The tDCS headpiece will be fitted by the researchers and participants provided with an instructional video regarding correct headpiece positioning. The tDCS device will be pre-programmed for both the active and sham conditions and the participant will be blinded to this allocation. During active tDCS, stimulation with a constant current intensity of 2mA will be applied over the motor cortex via a Soterix mini-tDCS Stimulator. The 5×7cm saline-soaked sponge electrodes snap into the custom headpiece, ensuring fail-safe electrode preparation. Participants will simply need to press a button with the headpiece appropriately positioned to receive the pre-programmed intervention and will not be able to modify any settings. Participants will remove the headpiece when the tDCS unit automatically turns off after 20 minutes. Participants will be supervised by researchers via secure videoconferencing software to provide support and monitor for adverse events. Lower limb strengthening We will use a 30-minute quadriceps strengthening program shown to be safe and effective during our previous studies in knee osteoarthritis (OA). Participants will perform the exercises twice per week for a total of 8 weeks. TheraBand and body weight exercises will be employed. A 10 Repetition Maximum (RM) test will be carried out by a trained exercise physiologist to determine appropriate exercise selection and resistance. Dosage will be 3 sets of 10 repetitions. Exercise will be unsupervised but participants can choose to receive feedback as needed via video teleconferencing. Adherence will be monitored via an exercise diary.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be deemed eligible if they meet the National Institute for Health and Care Excellence (NICE) diagnosis guidelines for clinical knee OA28 - are 45 years of age or older, have activity-related joint pain, and have either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes. We will also require participants to report an average weekly pain intensity score during movement of at least 40mm on a 100mm online visual analogue scale (VAS) with terminal descriptors of ‘no pain’ (0mm) and ‘extreme pain’ (100mm). Participants will require access to an electronic communication device (e.g., smartphone, tablet, or computer) for video conferencing sessions. Participants will be excluded if they have undergone knee or neurological surgery over the previous 12 months, present with neurological or musculoskeletal conditions affecting lower limb function, present with other chronic pain conditions (chronic low back pain, rheumatoid arthritis, fibromyalgia, etc.), present with contraindications to exercise as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)29 or have contraindications to receiving tDCS (such as the presence of implanted medical devices in the head or a history of serious brain injury). Participants will be asked to report any drugs that currently take at the time of the trial, with the medication type and dosage recorded during the baseline assessment. Participants will be excluded if they take any drugs known to interfere with tDCS such as benzodiazepines, as previously described.30 Other than drugs that may interfere with tDCS, participants will be permitted to continue to use their normal medications.
Exclusion criteria
Participants will be excluded if they have undergone knee surgery over the previous 12 months, present with other neurological or musculoskeletal conditions affecting lower limb function, or present with contraindications to exercise or tDCS.
Outcome results
None listed