Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001741875
Ethics application status
Approved
Date submitted
2/11/2021
Date registered
20/12/2021
Date last updated
6/02/2023
Date data sharing statement initially provided
20/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-regulation (Mindfulness Meditation and Brainwave) Training for People with Knee Osteoarthritis: A Feasibility and Safety Randomized Control Trial.
Scientific title
Mindfulness Meditation and EEG Neurofeedback Training for People with Knee Osteoarthritis: A Feasibility and Safety Randomised Control Trial.
Secondary ID [1] 305459 0
Health Research Council Reference: 21/616
Universal Trial Number (UTN)
U1111-1270-1234
Trial acronym
MiNT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 323845 0
Chronic Secondary Musculoskeletal Pain 323846 0
Chronic Pain 324608 0
Condition category
Condition code
Musculoskeletal 321351 321351 0 0
Osteoarthritis
Anaesthesiology 321352 321352 0 0
Pain management
Neurological 321353 321353 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group-1 will receive Electroencephalography-Neurofeedback (Brainwave) training + usual care.

Electroencephalography- Neurofeedback (EEG-NF) training is a form of biofeedback training designed to self-regulate activities of targeted neural areas to improve health outcomes. EEG-NF works under the principles of operant conditioning learning. Real-time feedback (reward) is provided to the participant on reaching a threshold level of the cortical electrical activity at the targeted brain regions linked to the pain experience, thereby supporting self-regulation of pain and health. In this trial, Electroencephalography (EEG) neurofeedback will be administered four times a week (30 minutes/ session) for a total of 3 consecutive weeks, by trained research personnel. During each session, participants will be asked to close their eyes and sit relaxed on a chair with back support. The Comby EEG lead cap with sensors will be placed on the individual’s scalp. The targeted brain region will include the pregenual anterior cingulate cortex (pgACC). The Brainmaster Inc. system delivers sound feedback (reward) each time the participant’s real-time brain activity at the targeted region meets the desired infraslow threshold (0.0–0.1 Hz) at the targeted cortical area(s). The reward threshold will be adjusted in real-time between 60-80%, i.e., for 60-80% of the time.

Group-2 will receive Mindfulness Meditation Training (MMT) + usual care.

Mindfulness Meditation Training (MMT): The MMT regimen will consist of twelve 20 minutes sessions which will be administered for three successive weeks with four sessions each week. A trained research assistant will administer the training. During each session, participants will be instructed to focus on the sensation of each breath occurring at the tip of the nose. On progression, participants will be instructed to broaden their focus to the "full flow of the breath", including bodily sensations. We will instruct participants to acknowledge thoughts, feelings, and emotions as they arise without judgment and "simply return their attention back to the breath sensations".

Participants in groups 1 and 2 will continue to receive the usual, normal routine care offered by their healthcare providers and carry out self-management strategies.

Adherence to training will be recorded through attendance at each training session.

Monitoring usual care: Participants (in groups 1 & 2) will record healthcare interventions received and self-management strategies carried out on a weekly basis during the training period. This would be recorded using a self-report questionnaire (digital or paper format).
Intervention code [1] 321868 0
Treatment: Devices
Intervention code [2] 321869 0
Treatment: Other
Intervention code [3] 322092 0
Rehabilitation
Comparator / control treatment
Usual care group (group-3): Participants will continue to receive healthcare interventions and carry out self-management strategies. They will be asked to refrain from practising any forms of mindfulness/meditation strategies during the study period. Following the 3 months post-intervention follow-up assessment, they will be offered to receive one of the active interventions. Participants in the usual care group will record healthcare interventions received and self-management strategies carried out. This would be recorded using a self-report questionnaire (digital or paper format).
Control group
Active

Outcomes
Primary outcome [1] 329136 0
Recruitment rates: The proportion of participants recruited from the total screened will be expressed as a percentage. Participants will be recruited over one year, with no threshold placed on the recruitment rate for each month. The number of participants contacted expressing interest to participate, the number of participants who underwent (preliminary and confirmatory) screening, randomised into one of the groups will be recorded. Recruitment rate/month: The number of participants recruited and randomised per month will be recorded. Recruitment rates will be also summarised based on the source of recruitment (newspaper, social media, university e-mail system).


Timepoint [1] 329136 0
Audit of study records throughout the study period.
Primary outcome [2] 329138 0
Compliance rate to training sessions: Adherence to training sessions will be measured as the number of training sessions attended by each participant expressed as a percentage of the total number of sessions.
Timepoint [2] 329138 0
Compliance rates: Audit of the training attendance record (3 weeks training period).
Primary outcome [3] 329139 0
Safety of training: The Discontinuation-Emergent Sign and Symptom (DESS), a 43-item checklist consisting of emotional, behavioural, cognitive and physical symptoms, will be used to record symptoms compared to the status prior to the training or the previous session. For each symptom, participants will have to choose from one of the following categories: new symptom; old symptom but worse; old symptom but improved; old symptom but unchanged and symptom not present. Participants’ views of the causal relationship of symptoms with the intervention will be measured using an ordinal item ranging from 1 (unrelated) to 5 (strongly related). Participants will also be encouraged to report any other symptoms that were not captured in the DESS checklist. The participants will have to report worsening side effects compared to the status before the training or the previous session. Options for open comments will be provided.
Timepoint [3] 329139 0
The safety data will be collected at each session by the training administrator and at immediately post-intervention (4th week) assessment and 3 months post-intervention completion.
Secondary outcome [1] 401577 0
Pain Severity: The Brief Pain Inventory - Short Form (pain subscale; 11-point numeric pain rating scale) will be used to evaluate the severity of pain [worst, least, average, and current pain intensity] in the past 24 hours, the past week and past four weeks.

Timepoint [1] 401577 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [2] 401578 0
The Brief Pain Inventory - Short Form (interference subscale- 9 items; subscale; 11-point numeric rating scale) evaluate the impact of pain on daily functioning (general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life) during the past 24 hours.
Timepoint [2] 401578 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [3] 401579 0
Knee injury and Osteoarthritis Outcome Score (KOOS) will be used to measure function in daily living (17 items), function in sport and recreation (5 items), and knee-related quality of life (4 items); 5-point Likert scale, with anchors of zero (no problems) to 4 (extreme problems).

Timepoint [3] 401579 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [4] 401580 0
Physical performance measures recorded using Osteoarthritis Research Society International (OARSI) recommended physical performance core set (30-second Chair Stand Test, Timed Up and Go Test, 40m Fast-paced Walk Test, Stair Climb Test, Six-Minute Walk Test) and standing balance tasks of the short physical performance battery (standing balance, 4-m walking speed, and ability to rise from a chair). Physical performance outcomes for each task will be assessed separately.






Timepoint [4] 401580 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [5] 401581 0
Pain Unpleasantness: A single-item; 0-10 Numeric Rating Scale (NRS) will be used to measure the unpleasantness of knee pain in the past 24 hours and the past week.
Timepoint [5] 401581 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [6] 401582 0
Pain Bothersomeness: A single-item; 0-10 Numeric Rating Scale (NRS) will be used to measure the bothersomeness of knee pain in the past 24 hours and the past week.
Timepoint [6] 401582 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [7] 401583 0
Movement evoked pain: Pain severity will be measured using the NPRS on a 0-100 scale (0 = no pain, 100 = the most intense pain imaginable) before, during and following physical performance tasks (Osteoarthritis Research Society International (OARSI) recommended physical performance core set and standing balance tasks of the short physical performance battery). Average moved evoked pain scores and sensitivity movement evoked pain indexes will be calculated.

Timepoint [7] 401583 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [8] 401584 0
Depression, Anxiety and Stress: Depression, anxiety, and stress scale (21 items) will be used to measure distress along the 3 axes of depression, anxiety and stress.
Timepoint [8] 401584 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [9] 402536 0
Pain Catastrophising Thoughts: Pain Catastrophising Scale will be used to measure the degree of rumination, magnification and helplessness when experiencing pain using the 0 (not at all) to 4 (all the time) scale.
Timepoint [9] 402536 0
Baseline, Immediate following intervention (4th week) and 3 months post-intervention completion
Secondary outcome [10] 402537 0
Control of emotions: Emotional Regulation Questionnaire (10-item scale) will be used to measure the tendency to regulate their emotions in two ways: Cognitive Reappraisal and Expressive Suppression. Each item will be rated on a 7-point ordinal response scale ranging from 1 (strongly disagree), 4 Neutral to 7 (strongly agree).
Timepoint [10] 402537 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [11] 402538 0
Affect style: Positive and Negative Affect Scale (20 items) will be used. Each item will be rated on a five-point ordinal response scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely.
Timepoint [11] 402538 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [12] 402539 0
Illness perceptions: Brief Illness Perception Questionnaire (8 items) will be used to assess cognitive perceptions such as effect on life, duration of pain, control over pain, beliefs about the effectiveness of treatment, the experience of symptoms, concerns about pain, and mood.
Timepoint [12] 402539 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [13] 402540 0
Mindfulness: Five-Facet Mindfulness Questionnaire (15 items) will be used to assess elements of mindfulness (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Each item will be rated on a five-point ordinal response scale, ranging from 1 = Never or very rarely true to 5 = Very often or always true.
Timepoint [13] 402540 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [14] 402541 0
Coping levels: Brief Pain Coping Scale for osteoarthritis will be used to assess coping strategies to manage pain.
Timepoint [14] 402541 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [15] 402542 0
Pain self-efficacy: Pain Self Efficacy Questionnaire (2-item) will be used to measure the confidence in one's ability to work and lead a normal life despite pain. Each item will be rated on 7-point scale: 0 = not at all confident and 6 = completely confident.
Timepoint [15] 402542 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [16] 402543 0
European Quality of Life- 5D scores
Timepoint [16] 402543 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [17] 402544 0
Sleep quality and disturbances:
Pittsburgh Sleep Quality Index (19 items) will be used to assess sleep quality over a 1-month time interval. Scored 0 (no difficulty) to 3 (severe difficulty). Total score (range 0 to 21).
Timepoint [17] 402544 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [18] 402545 0
Global perceived change: Perceived change in the knee pain on an 11-point scale when compared to baseline/before training rated: -5=much worse, through 0=unchanged, to +5=completely, recovered)
Timepoint [18] 402545 0
Immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [19] 402546 0
Acceptability of interventions: Visual analogue scales (0-10) will be used to measure the seven component constructs of the theoretical framework of acceptability: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.
Timepoint [19] 402546 0
Baseline, and immediate post-intervention (4th week).

Secondary outcome [20] 402547 0
Perceived treatment satisfaction: Single-item; Rated on a 0-10 NRS; 0- not at all satisfied to 10- highly satisfied.
Timepoint [20] 402547 0
Immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [21] 402548 0
Credibility/expectancy of the intervention: The credibility/expectancy questionnaire (6 items).
will be used to measure treatment expectancy and rationale credibility of interventions.
Timepoint [21] 402548 0
Baseline
Secondary outcome [22] 402549 0
Pressure Pain Threshold: A computerised, handheld digital algometer (AlgoMed; Medoc, Ramat Yishai, Israel) will be used to measure three trials of PPT over the two regions (index knee and non-dominant wrist) in random order.
Timepoint [22] 402549 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [23] 402550 0
The current source density of cortical areas, functional connectivities measured through resting-state and evoked electroencephalography.
Timepoint [23] 402550 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [24] 402551 0
Level of engagement with the training:
Single-item; Rated on a 10-point ordinal items scale, where 1 = least engaged and 10 = highly engaged.
Timepoint [24] 402551 0
At each training session.
Secondary outcome [25] 402552 0
The level of motivation to participate in the training will be measured using an adapted version of the Questionnaire for Current Motivation-Brain Computer Interference (QCM-BCI) recorded on a 7-point ordinal response scale.
Timepoint [25] 402552 0
Baseline assessment and at each training session.
Secondary outcome [26] 402553 0
Costs: The Osteoarthritis Cost-and-Consequences Questionnaire will be used to record healthcare use/expenses in the past three months before the study period and 3 months period post-intervention completion.
Timepoint [26] 402553 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [27] 402554 0
Physical activity levels: International Physical Activity Questionnaire—short form in the last seven days
Timepoint [27] 402554 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [28] 402555 0
Semi-structured in-depth interviews (one-on-one, 60 minutes maximum, audio-recorded) exploring participant experiences in the trial which includes barriers and facilitators in participating in the trial, perceptions/acceptability towards the intervention and the research procedures, preferences for study site, the perceived value of the study and acceptability of interventions as potential clinical treatments for the management of the knee OA. Usual care group participants will also be interviewed exploring experiences in participating in the trial including the acceptability of the assessment procedures.
Timepoint [28] 402555 0
Within three months of completing the intervention.
Secondary outcome [29] 402560 0
Heart rate will be recorded using the polar heart rate monitor at rest, before, during and after physical performance procedures; before, during and after the cold pressor task.
Timepoint [29] 402560 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [30] 403964 0
Participant retention rate (Dropout rates): The percentage of allocated participants who completed immediate post-intervention and the follow-up assessment in each group will be measured. The dropout rate is one of the primary outcomes in this feasibility trial.
Timepoint [30] 403964 0
Audit of the attendance record of immediate post-intervention (4th week) assessment and at 3 months post-intervention completion assessment.
Secondary outcome [31] 403965 0
Mechanical temporal summation (MTS) will be assessed using a nylon monofilament (Semmes monofilament 6.65, 300 g). Brief ten repetitive contacts will be delivered at a rate of 1 Hz, externally cued by auditory stimuli. The participants will be asked to rate the level of pain experienced on the 11-point NPRS (0=No pain to 100=Extreme pain) immediately after the first contact and rate their greatest pain intensity after the 10th contact. Three trials will be conducted for each of the two regions (i.e., index knee and non-dominant wrist) in random order. MTS will be calculated as the difference between the NPRS rating after the first contact and the highest pain rating after the 10th contact for each trial. A similar protocol will administered during resting-state EEG recordings.
Timepoint [31] 403965 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion
Secondary outcome [32] 403966 0
Conditioned pain modulation (CPM): The conditioning stimulus will consist of a cold pressor task. Test stimulus: A computerised, handheld digital algometer (AlgoMed; Medoc, Ramat Yishai, Israel) will be used to measure suprathreshold PPT (pain40) at the non-dominant leg region (tibialis anterior muscle). Two PPT (pain40) trials will be recorded before conditioning stimulus and will be averaged to obtain a baseline score, One PPT (pain40) trial will be recorded 30 seconds following immersion and then three PPT (pain40) trials will be recorded in the same region at 30, 60, and 90 seconds immediately after the conditioning stimulus. Calculation of CPM: A percent change score will be calculated for each time point (i.e., CPM30sec, CPM60sec, and CPM90sec), with a positive score indicating an increase in PPTs (pain40) after the conditioning stimulus and thus the presence of CPM effect.

Timepoint [32] 403966 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion
Secondary outcome [33] 403967 0
Blood pressure will be recorded using the digital sphygmomanometer at rest, before and after physical performance procedures, before, during and after the cold pressor task.
Timepoint [33] 403967 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion
Secondary outcome [34] 403968 0
Heart Rate Variability: Resting heart rate and beat-to-beat R-R interval within 2-ms resolution will be obtained using a Polar V800 HR monitor and a Polar H10 chest Pro Strap. All participants will be seated, and the data will be collected for 7 minutes. Automated office blood pressure measurement will be used to measure blood pressure (BP) readings with participants resting in a quiet room. The respiratory rate will be measured. Raw heart rate and R-R interval time series data will be downloaded from the Polar flow software for further processing and analysis. Kubios software https://www.kubios.com/hrv-premium/ will be used to derive heart rate variability (HRV) from R-R interval record exported from polar flow in the time and frequency domains. Heart Rate Variability (HRV) measures are linked to pain severity ratings and a potential mediator of training outcomes.
Timepoint [34] 403968 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [35] 403970 0
Qualitative data: Maori perceptions of how assessment and treatment practices acceptable to a Maori worldview will be explored using the semi-structured in-depth interviews (one-on-one, 60 minutes maximum, audio-recorded for further analysis to develop themes)
Timepoint [35] 403970 0
Within 3 months post-intervention completion.
Secondary outcome [36] 403978 0
Peripheral oxygen saturation levels will be measured using pulse oximetry at rest, before and after physical performance procedures, before, during and after the cold pressor task.
Timepoint [36] 403978 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [37] 403979 0
State Anxiety: The State Anxiety Inventory will be used to measure state anxiety.
Timepoint [37] 403979 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [38] 403980 0
Pain quality: PainDETECT questionnaire (12 items); Rated on a 5-point ordinal response scale (1 = never to 5 = very strongly); pain radiation: 1 item (yes or no), pain course pattern (scored from -1 to 2). Total score: -1 to 38 points.
Score classification: = 12- nociceptive pain, 13–18- possible neuropathic pain component, = 19- likely neuropathic pain.
Timepoint [38] 403980 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [39] 403981 0
Intermittent and Constant Osteoarthritis Pain: The Measure of Intermittent and Constant Osteoarthritis Pain (11 items). 2 subscales: Constant pain (5 items), Intermittent pain (6 items). Each item within each subscale is rated on a 5-point ordinal response scale (Not at all/No constant or intermittent knee pain, Mildly, Moderately, Severely, Extremely). A higher score indicates worse pain.
Timepoint [39] 403981 0
Baseline, immediate post-intervention (4th week) and 3 months post-intervention completion.
Secondary outcome [40] 418174 0
Osteoarthritis Flare-up:

The Flare-OA questionnaire (16-item) is a newly developed questionnaire to capture (occurrence and intensity) flare-ups in knee OA symptoms among five domains (pain, stiffness, swelling, psychological aspects, consequences of symptoms), producing a composite score. It is a multidimensional scale producing a single continuous score from 0=none to 10=highest possible flare.
Timepoint [40] 418174 0
Baseline, immediate post-intervention (4/5th week) and 3 months post-intervention completion.

Eligibility
Key inclusion criteria
Inclusion criteria: Adults between the ages of 45-85 years, currently living in the wider Dunedin region, meeting 1986 American College of Rheumatology (ACR) clinical criteria for the diagnosis of knee OA, and with knee pain that persisted for longer than three months, will be eligible to participate.

Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Systemic rheumatic conditions (e.g. rheumatoid arthritis, gout), neurological conditions (e.g. stroke, multiple sclerosis, Parkinson’s disease), untreated heart disease, peripheral arterial diseases in the legs, uncontrolled hypertension (greater than or equal to 150/95), major psychiatric illness, cognitive impairment (Dementia, Alzheimer’s disease), underwent knee joint replacement or other types of surgery to the index knee, intra-articular steroid injections in the past 3 months, Intra-articular hyaluronic acid injections in the past six months, underwent knee joint replacement or knee surgery, scheduled to undergo joint replacement surgery within six months of enrollment, former neurosurgical procedures of the brain, and recent/current pregnancy, former neurosurgical procedures of the brain, and presence of electronic implants or metal implants in the head and neck region

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)
Allocation concealment: The allocation of groups will be concealed using opaque envelopes (one for each allocation, numbered in order) to conceal the sequence until interventions were assigned. The senior biostatistician will prepare and then provide the opaque sealed envelopes to the assistant research fellow (ARF).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation: Following baseline assessment, participants will undergo allocation into one of the three study groups with equal probabilities. Blocks of unequal length, with the lengths and the probabilities of these lengths not known to other investigators, will be used to promote allocation concealment. The senior biostatistician, using non-informative group allocation codes (where the unblinding will not be revealed to them until all planned analyses are completed), will generate the allocation sequence using standard computer software. The ARF will give the opaque sealed envelope to the research assistant, who will disclose the intervention to the participants and administer one of the active interventions: a) MMT +usual care, b) EEG-NF training +usual care. If a participant is identified to be allocated to the usual care control group, they would be advised to continue managing their health condition as they regularly do and appear for the assessment sessions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Quantitative data analyses plan: Descriptive statistics will be calculated for all outcome measures. As this is a feasibility study, sample size estimation will not assess treatment effects and therefore efficacy of the interventions cannot be determined.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/02/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
29/03/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24288 0
New Zealand
State/province [1] 24288 0
Otago

Funding & Sponsors
Funding source category [1] 309817 0
Government body
Name [1] 309817 0
Health Research Council of New Zealand
Country [1] 309817 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street,
North Dunedin,
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 310851 0
University
Name [1] 310851 0
University of Otago
Address [1] 310851 0
School of Physiotherapy,
Centre for Health, Activity and Rehabilitation Research,
325 Great King Street,
North Dunedin,
Dunedin 9016
Country [1] 310851 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309560 0
Health and Disability Ethics Committee
Ethics committee address [1] 309560 0
Ethics committee country [1] 309560 0
New Zealand
Date submitted for ethics approval [1] 309560 0
20/10/2021
Approval date [1] 309560 0
11/01/2022
Ethics approval number [1] 309560 0
2021 EXP 11367

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

Contacts
Principal investigator
Name 114590 0
Dr Ramakrishnan Mani
Address 114590 0
School of Physiotherapy,
Centre for Health, Activity and Rehabilitation Research,
University of Otago,
325 Great King Street,
North Dunedin,
Dunedin 9016
Country 114590 0
New Zealand
Phone 114590 0
+64 34793485
Fax 114590 0
Email 114590 0
ramakrishnan.mani@otago.ac.nz
Contact person for public queries
Name 114591 0
Ramakrishnan Mani
Address 114591 0
School of Physiotherapy,
Centre for Health, Activity and Rehabilitation Research,
University of Otago,
325 Great King Street,
North Dunedin,
Dunedin 9016
Country 114591 0
New Zealand
Phone 114591 0
+64 34793485
Fax 114591 0
Email 114591 0
ramakrishnan.mani@otago.ac.nz
Contact person for scientific queries
Name 114592 0
Ramakrishnan Mani
Address 114592 0
School of Physiotherapy,
Centre for Health, Activity and Rehabilitation Research,
University of Otago,
325 Great King Street,
North Dunedin,
Dunedin 9016
Country 114592 0
New Zealand
Phone 114592 0
+64 34793485
Fax 114592 0
Email 114592 0
ramakrishnan.mani@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided


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.