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Can non-invasive electrical brain stimulation improve exercise rehabilitation outcomes in people with hip osteoarthritis?

Assessing the impact of transcranial direct current stimulation on hip osteoarthritis burden (the STIM HIPS study): a protocol for a randomised, triple blind controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000129583
Acronym
STIM Hips
Enrollment
17
Registered
2024-02-13
Start date
2024-09-20
Completion date
2026-06-26
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective of this randomised controlled trial is to quantify the effect of tDCS and exercise on pain, disability and QoL in people with hip OA. Our secondary objectives include: 1) quantifying the influence of motor cortex excitability and CPM on treatment effects, and 2) quantifying the economic cost/ benefit of tDCS for improving health-related QoL in people with hip OA.

Interventions

Transcranial direct current stimulation (tDCS) devices (Brain Premier tDCS E1 Plus) will deliver a weak current [</=2 milliamps (mA)] from a 35x35mm anodal electrode [that increases cortical excitability] on the scalp at the vertex (overlying primary motor cortex of the more symptomatic limb) to a cathodal electrode placed over the deltoid tubercle on the upper arm. The physiotherapist will also train the participant in how to self-perform tDCS on non-supervised days, but will be nearby to provi

Transcranial direct current stimulation (tDCS) devices (Brain Premier tDCS E1 Plus) will deliver a weak current [</=2 milliamps (mA)] from a 35x35mm anodal electrode [that increases cortical excitability] on the scalp at the vertex (overlying primary motor cortex of the more symptomatic limb) to a cathodal electrode placed over the deltoid tubercle on the upper arm. The physiotherapist will also train the participant in how to self-perform tDCS on non-supervised days, but will be nearby to provide any assistance if needed. Real tDCS will be performed at 2mA for 20 minutes whilst completing exercise rehabilitation. The exercise rehabilitation intervention will be identical between groups and will be reported as per the Consensus on Exercise Reporting Template (CERT). Participants will be provided an 8-week gym membership at the provider physiotherapy clinic. The intervention will involve 8 weeks of physiotherapist-supervised exercise, consisting of three in-person visits/ week in which participants receive tDCS during each session. Exercise will be based on templates, sent via Physitrack®, however these will be individually adapted as able and progressed when participants can complete the prescribed exercise. Reporting items from CERT. 1. The majority of exercises will use body weight resistance, however the following additional equipment will be utilised: knee extension machine, hamstring curl machine, leg press machine, circular TheraBand. 2. All exercises will be prescribed by a qualified physiotherapist, with greater than five years of experience in managing chronic hip pain. 3. Exercises will be prescribed individually and performed individually, however there may be other rehabilitation patients and clinicians in the rehabilitation gymnasium at the same time. 4. Participants will receive 1:1 supervision by a physiotherapist for one rehabilitation session per fortnight (which will include progressing exercises). All other rehabilitation sessions will be unsupervised. 5. Attendance at the rehabilitation centre will be recorded via private practice standard booking system. 6. Participants will receive reminder text messages about physiotherapy consultations. 7. All exercises will be prescribed so they are either pain free or have minimal pain (=2/10 on a numerical rating scale of pain) when performed. Exercises will be progressed when all sets and repetitions can be performed. 8. The exercise progressions will be based on patient function but must include: • A single joint exercise for each of the following muscle groups: lumbar extensors; abdominals; hip extensors; hip flexors, hip abductors; hip adductor; knee flexors; knee extensors; ankle plantar flexors. • A multi joint squat pattern (e.g., squat) and bend pattern (e.g., deadlift) movement. • one balance-based exercise (e.g., star excursion balance). 9. Adverse events will be reported to all study staff as they occur. 10. Exercises will be performed in a physiotherapy rehabilitation gymnasium. 11. Participants will be provided double leg single joint exercises (e.g., double leg bridge), before being progressed to single leg single joint exercises (e.g., single leg bridge) and then more highly loaded single leg single joint exercises (e.g., single leg hip thrust). Sets and repetitions will be based on endurance repetitions (e.g., 3 x 15 reps) and performed three times per week. 12. Exercises will follow the description above but will be individually tailored to the participant and progressed as able. 13. Exercises will be progressed when participants can perform 3 x 15 repetitions or regressed if they are causing pain > 2/10. 14. All participants will be commenced with double leg single joint exercises and progressed as able. 15. Adherence will be determined as the number of sessions attended across the 8-week intervention divided by the number of prescribed sessions.

Sponsors

Edith Cowan University, 270 Joondalup Drive, Joondalup, WA
Lead SponsorUniversity

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
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Clinical and radiological diagnosis of hip OA will be undertaken (includes accounting for dropouts). The clinical and radiological diagnosis will be made via a Sports and Exercise Physician. The clinical diagnosis includes activity-related hip pain (>3/10) and positive Flexion Adduction and Internal Rotation (FADDIR) tests. Radiological OA will be categorised as a Kellgren Lawrence score of greater than or equal to 2.

Exclusion criteria

Rehabilitation in past 6-months; previous lower-limb surgery; hip joint injection within 3 months; neurological conditions; cardiometabolic conditions that preclude exercise; inability to commit to rehabilitation; specific transcranial magnetic stimulation and tDCS (Pregnancy; Neurological conditions/illness, including epilepsy/convulsion/seizure Vascular, traumatic, tumorous, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication; previous or current implants in their body that may be triggered or heated by an electrical current (e.g. pacemaker, intracranial shunts, artificial cochlea, etc); Any mental implanted in their head (e.g. surgical clips, staples, shrapnel); Frequent or intense headaches; Previous brain trauma or neurosurgical intervention Serious medical complications (e.g. advanced pulmonary, cardiac, liver or kidney disease) or CPM contraindications (Cold urticaria; Raynaud’s phenomenon); inability to understand English.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026