Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000129583p
Ethics application status
Submitted, not yet approved
Date submitted
15/01/2024
Date registered
13/02/2024
Date last updated
13/02/2024
Date data sharing statement initially provided
13/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can non-invasive electrical brain stimulation improve exercise rehabilitation outcomes in people with hip osteoarthritis?
Scientific title
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.
Secondary ID [1] 311335 0
None
Universal Trial Number (UTN)
Trial acronym
STIM Hips
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 332590 0
Condition category
Condition code
Musculoskeletal 329285 329285 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327779 0
Treatment: Other
Intervention code [2] 327888 0
Treatment: Devices
Comparator / control treatment
Sham tDCS will be applied during exercise with the placebo setting active (ramping to give the sensation of tDCS, then dropping to no output with the screen falsely reporting 2mA of output) whilst completing exercise rehabilitation. Other than electrical stimulation, real and sham procedures are identical.

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.
Control group
Placebo

Outcomes
Primary outcome [1] 337107 0
Pain
Timepoint [1] 337107 0
Baseline and then 4, 8 and 16 weeks post baseline.
Primary outcome [2] 337268 0
Disability
Timepoint [2] 337268 0
Baseline and then 4, 8 and 16 weeks post baseline.
Secondary outcome [1] 430728 0
Motor cortex excitability
Timepoint [1] 430728 0
Baseline and then 8 weeks post baseline.
Secondary outcome [2] 430729 0
Quadriceps Voluntary Activation
Timepoint [2] 430729 0
Baseline and then 8 weeks post baseline.
Secondary outcome [3] 430730 0
Conditioned pain modulation (CPM) - local
Timepoint [3] 430730 0
Baseline and then 8 weeks post baseline.
Secondary outcome [4] 430731 0
Health-related quality of life
Timepoint [4] 430731 0
Baseline and then 4, 8 and 16 weeks post baseline.
Secondary outcome [5] 430735 0
Pain with sit-to-stand
Timepoint [5] 430735 0
Baseline and 8 weeks post baseline.
Secondary outcome [6] 430736 0
Hip muscle strength
Timepoint [6] 430736 0
Baseline and 8 weeks post baseline
Secondary outcome [7] 430737 0
Medications
Timepoint [7] 430737 0
Baseline and 4, 8 and 16 weeks post baseline.
Secondary outcome [8] 430738 0
Physical activity level
Timepoint [8] 430738 0
Baseline and 4, 8 and 16 weeks post baseline.
Secondary outcome [9] 430739 0
Smoking status
Timepoint [9] 430739 0
Baseline and 4, 8 and 16 weeks post baseline.
Secondary outcome [10] 430740 0
Alcohol Intake
Timepoint [10] 430740 0
Baseline and 4, 8 and 16 weeks post baseline.
Secondary outcome [11] 430741 0
Anxiety
Timepoint [11] 430741 0
Baseline and 4, 8 and 16 weeks post baseline.
Secondary outcome [12] 430742 0
Depression
Timepoint [12] 430742 0
Baseline and 4, 8 and 16 weeks post baseline.
Secondary outcome [13] 430743 0
Depression, anxiety and stress composite score
Timepoint [13] 430743 0
Baseline and 4, 8 and 16 weeks post baseline.
Secondary outcome [14] 430744 0
Exercise and consultation adherence
Timepoint [14] 430744 0
Daily from baseline to end of intervention at 8-weeks.
Secondary outcome [15] 430745 0
Adverse events
Timepoint [15] 430745 0
This will be reported by participants at any time an adverse event may occur in the 0-16 week follow up period.
Secondary outcome [16] 431277 0
CPM - Remote
Timepoint [16] 431277 0
Baseline and then 8 weeks post baseline.
Secondary outcome [17] 431278 0
Knee muscle strength
Timepoint [17] 431278 0
Baseline and 8 weeks post baseline

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each tDCS device will be numbered (numbers ranging from 1-8 as we have 10 tDCS devices, allowing 2 in reserve if devices are lost/ damaged). The study coordinator (CS) will program each tDCS device to a real or sham program [1:1 (real:sham)]. Participants will then be randomly allocated via the study coordinator to a device and will use this single device during all rehabilitation sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following recruitment, participants will be randomised using a computer-generated randomisation list to one-of-two groups: 1) real anodal tDCS + exercise or, 2) sham anodal tDCS + exercise.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis
All data will be described at baseline and across each time point. Data distributions will be examined for each outcome using Shapiro Wilk test and guide preliminary statistical between group test selections. Repeated mixed effects models will determine between-group differences for the primary outcome (iHOT-33), accounting for relevant confounders (i.e., age; sex; BMI; radiographic severity) with relevant model assumptions examined. Secondary analysis will determine between-group differences for the other outcomes of interest (cortex excitability and CPM). Results will be reported according to EQUATOR Network reporting guidelines which include SAMPL and CONSORT. Statistical analysis will be performed by a blinded biostatistician from a separate institute (A/Prof Chivers).

Economic analysis
Participants will have no out-of-pocket costs. However, usual financial costs ($AUD) associated with tDCS usage and supervised physiotherapy if not included within this trial will be recorded using market average. Furthermore, market average costs from reported medications will be included. A subsequent economic evaluation with the healthcare system as the agent subject to costs, will estimate the incremental cost associated with the intervention per quality-adjusted life year using the EQ-5D-5L.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315590 0
Charities/Societies/Foundations
Name [1] 315590 0
Raine Medical Research Foundation
Country [1] 315590 0
Australia
Primary sponsor type
University
Name
Edith Cowan University, 270 Joondalup Drive, Joondalup, WA
Address
270 Joondalup Drive, Joondalup, WA, 6027
Country
Australia
Secondary sponsor category [1] 317831 0
Individual
Name [1] 317831 0
Myles Murphy
Address [1] 317831 0
Country [1] 317831 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314482 0
Edith Cowan University Human Research Cowan University
Ethics committee address [1] 314482 0
270 Joondalup Drive, Joondalup, WA, 6027
Ethics committee country [1] 314482 0
Australia
Date submitted for ethics approval [1] 314482 0
08/01/2024
Approval date [1] 314482 0
Ethics approval number [1] 314482 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131742 0
Dr Myles Murphy
Address 131742 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 131742 0
Australia
Phone 131742 0
+618 6304 3545
Fax 131742 0
Email 131742 0
m.murphy@ecu.edu.au
Contact person for public queries
Name 131743 0
Dr Myles Murphy
Address 131743 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 131743 0
Australia
Phone 131743 0
+618 6304 3545
Fax 131743 0
Email 131743 0
m.murphy@ecu.edu.au
Contact person for scientific queries
Name 131744 0
Dr Myles Murphy
Address 131744 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027
Country 131744 0
Australia
Phone 131744 0
+618 6304 3545
Fax 131744 0
Email 131744 0
m.murphy@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data will be shared.
When will data be available (start and end dates)?
From 31/12/2026 for 25 years until data will be removed.
Available to whom?
All data will be made available upon reasonable request.
Available for what types of analyses?
For IPD meta-analysis.
How or where can data be obtained?
Final data will be stored within the Edith Cowan University Research Repository. Until data is stored in the repository requests should be emailed to m.murphy@ecu.edu.au.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.