Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000397516p
Ethics application status
Submitted, not yet approved
Date submitted
25/02/2024
Date registered
3/04/2024
Date last updated
27/10/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring whether home-based neuromodulation can boost the potential analgesic effects of exercise in people with knee osteoarthritis
Scientific title
Exploring whether home-based neuromodulation can boost the potential analgesic effects of exercise in people with knee osteoarthritis
Secondary ID [1] 311603 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 333020 0
Condition category
Condition code
Musculoskeletal 329708 329708 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328058 0
Treatment: Devices
Comparator / control treatment
The sham condition will involve identical procedures, except the pre-programmed sham protocol (which delivers no actual stimulation to the motor cortex) will be employed.
Control group
Placebo

Outcomes
Primary outcome [1] 339269 0
Feasibility
Timepoint [1] 339269 0
These outcomes will be analysed daily from baseline until the end of the trial after week 8.
Primary outcome [2] 339270 0
Feasibility
Timepoint [2] 339270 0
These outcomes will be analysed daily from baseline until the end of the trial after week 8.
Primary outcome [3] 339271 0
Safety
Timepoint [3] 339271 0
These outcomes will be analysed daily from baseline until the end of the trial after week 8.
Primary outcome [4] 339272 0
Safety
Timepoint [4] 339272 0
Safety will be assessed daily from baseline until the end of the trial after week 8.
Secondary outcome [1] 439329 0
Pressure pain thresholds
Timepoint [1] 439329 0
At baseline, week 4, and week 8 post-intervention commencement
Secondary outcome [2] 439330 0
Pressure pain thresholds
Timepoint [2] 439330 0
At baseline, week 4, and week 8 post-intervention commencement
Secondary outcome [3] 439331 0
Pressure algometry will be applied over the rectus femoris bilaterally, as well as the base of the thumb nail bilaterally.
Timepoint [3] 439331 0
At baseline, week 4, and week 8 post-intervention commencement
Secondary outcome [4] 439332 0
Pressure algometry will be applied over the rectus femoris bilaterally, as well as the base of the thumb nail bilaterally.
Timepoint [4] 439332 0
Will be assessed at baseline and then the end of each week for 12 weeks.
Secondary outcome [5] 439333 0
Pain every week from baseline until the end of the trial (week 8)
Timepoint [5] 439333 0
Will be assessed at baseline and then the end of each week for 12 weeks.
Secondary outcome [6] 439334 0
Pain every week from baseline until the end of the trial (week 8)
Timepoint [6] 439334 0
Pain will be assessed via a daily report every week from baseline until the end of the trial (week 8)
Secondary outcome [7] 439335 0
Pressure pain thresholds
Timepoint [7] 439335 0
Pain will be assessed via a daily report every week from baseline until the end of the trial (week 8)
Secondary outcome [8] 439336 0
Pressure pain thresholds
Timepoint [8] 439336 0
Pressure pain thresholds (PPT) are a reliable measure in people with knee OA43 and will be recorded in person at baseline, four weeks, and eight weeks.

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

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
24/12/2024
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315911 0
Commercial sector/Industry
Name [1] 315911 0
Arthritis Australia
Country [1] 315911 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 318060 0
University
Name [1] 318060 0
Queensland University of Technology
Address [1] 318060 0
Country [1] 318060 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314758 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 314758 0
Ethics committee country [1] 314758 0
Australia
Date submitted for ethics approval [1] 314758 0
01/03/2024
Approval date [1] 314758 0
Ethics approval number [1] 314758 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132630 0
Dr Rocco Cavaleri
Address 132630 0
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560, Australia .Western Sydney University, Campbelltown, Building 24, Room 2.103
Country 132630 0
Australia
Phone 132630 0
+61246203994
Fax 132630 0
Email 132630 0
[email protected]
Contact person for public queries
Name 132631 0
Rocco Cavaleri
Address 132631 0
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560, Australia .Western Sydney University, Campbelltown, Building 24, Room 2.103
Country 132631 0
Australia
Phone 132631 0
+61246203994
Fax 132631 0
Email 132631 0
[email protected]
Contact person for scientific queries
Name 132632 0
Rocco Cavaleri
Address 132632 0
Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560, Australia . Western Sydney University, Campbelltown, Building 24, Room 2.103
Country 132632 0
Australia
Phone 132632 0
+61246203994
Fax 132632 0
Email 132632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, sex, pain outcomes, group allocation
When will data be available (start and end dates)?
Immediately following publication and available for 5 years after publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Upon reasonable request via email([email protected]) to the Principal Investigator


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.