Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000615886
Ethics application status
Approved
Date submitted
20/02/2021
Date registered
21/05/2021
Date last updated
21/05/2021
Date data sharing statement initially provided
21/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The iSTOPP Study: Impact of Sensory Training On Persistent Pain
Scientific title
A pilot randomised clinical trial of sensory discrimination training in people with neck pain: proof-of-concept and feasibility
Secondary ID [1] 301453 0
None
Universal Trial Number (UTN)
U1111-1252-9527
Trial acronym
iSTOPP (Impact of Sensory Training On Persistent Pain)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent neck pain 317768 0
Condition category
Condition code
Musculoskeletal 315833 315833 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the experimental group will undergo 60-minutes/day x 5-days/week x four weeks of in-home tactile acuity training with the iTAD in addition to their usual physiotherapy care. The iTAD consists of a wearable neoprene collar, containing 12 hemispherical nodes, each enclosing a vibrotactile stimulator. The nodes contact the back of the neck and are wirelessly connected to tablet computer and custom application. The application triggers vibrotactile stimulations, records the user responses, provides feedback and calculates accuracy scores. Training consists of two types of games: The localisation game, where users are asked to indicate the location of a single vibration by, selecting the corresponding location on the tablet; and the orientation game, where users are asked to indicate the direction of a second vibration, relative to a first, by selecting the corresponding arrow.

Participants will receive approximately 20-minutes of training in the correct application of the iTAD, and the operation of the iTAD tablet computer and associated games. Training will be provided by the non-blinded researcher (physiotherapist). Intensity of the vibrations will be constant, and at a frequency of approximately 220Hz.

Application analytics will be used to monitor adherence to the intervention.
Intervention code [1] 317763 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will undergo their usual physiotherapy care plus a placebo intervention. The placebo component of the control intervention is specifically designed to control for non-specific effects of the iTAD, usual care treatment effects, time-based effects and the effects of clinician interaction. The participants in the placebo group will undergo four weeks of in-home use of a placebo Transcutaneous Electrical Nerve Stimulation (TENS) unit that will be referred to as iTENS (inhibitory TENS). In order to match time spent with the iTAD, participants will be instructed to use the iTENS for one hour per day, five days per week. The devices are altered such that no electrical current is delivered to the user. However, the unit will look fully operational.
Control group
Placebo

Outcomes
Primary outcome [1] 324035 0
Two-point discrimination threshold (TPDT) assessed using digital sliding two-point Vernier Calliper.
Timepoint [1] 324035 0
TPDT will be assessed immediately prior to intervention commencement, 2-weeks after commencement of the 4-week intervention, 5-weeks after commencement of the 4-week intervention, and 2-months after commencement of the 4-week intervention.
Primary outcome [2] 324036 0
Feasibility will be considered a composite outcome that will be judged based on data taken from recruitment logs, iTAD digital usage logs, participant completion rates, and questionnaires related to treatment satisfaction (5-point rating scale, from 1=very satisfied to 5=very disatisfied), blinding (Bang's Blinding Index) and treatment credibility (Perceived Treatment Credibility Scale). In order for the current protocol to be considered feasible for a full-scale RCT, a minimum threshold for recruitment, adherence, treatment completion, treatment satisfaction, blinding, and treatment credibility will need to be reached.
Timepoint [2] 324036 0
Recruitment rates, adherence (training duration), dropouts, Bang’s Blinding Index, and Treatment satisfaction scale will be assessed 2-months after treatment commencement. Credibility of the interventions will be assessed 3-days after treatment commencement so as to avoid influence by perceived treatment efficacy.
Primary outcome [3] 326610 0
Locognosia, the ability to localise touch, will be assessed with a manual localisation task. Twelve locations (numbered 1-12) will be marked on the neck, in three rows of four. Over 36 trials, the researcher will touch a location, and participants will guess which location was stimulated. Score will be given as percentage correct.
Timepoint [3] 326610 0
Lognognosia will be assessed immediately prior to intervention commencement, 2-weeks after commencement of the 4-week intervention, 5-weeks after commencement of the 4-week intervention, and 2-months after commencement of the 4-week intervention.
Secondary outcome [1] 383595 0
Average pain intensity over the last week will be assessed using a 0-10 NRS, where 0=no pain, and 10=the worst imaginable pain.
Timepoint [1] 383595 0
Average pain intensity will be assessed immediately prior to intervention commencement, 2-weeks after commencement of the 4-week intervention, 5-weeks after commencement of the 4-week intervention, and 2-months after commencement of the 4-week intervention.
Secondary outcome [2] 383600 0
Pain spread will be assessed by asking participants to colour in a digital body chart in a manner representing their usual pain over the last week.
Timepoint [2] 383600 0
Pain spread will be assessed immediately prior to intervention commencement, 2-weeks after commencement of the 4-week intervention, 5-weeks after commencement of the 4-week intervention, and 2-months after commencement of the 4-week intervention.
Secondary outcome [3] 392115 0
Tactile acuity as assessed by the iTADs overall composite score. The overall score is an average of two tactile acuity sub scores: the localisation test and orientation test scores.
Timepoint [3] 392115 0
Tactile acuity will be assessed with the iTAD will be assessed immediately prior to intervention commencement, 2-weeks after commencement of the 4-week intervention, 5-weeks after commencement of the 4-week intervention, and 2-months after commencement of the 4-week intervention.

Eligibility
Key inclusion criteria
Participants will be considered for the study if aged 18 to 75, have had neck pain of at least 6 months duration and report an average neck pain intensity of at least 3 on a 10-point numeric pain rating scale (NRS) over the past week.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded on the basis of the following criteria: have a diagnosed systemic inflammatory condition (e.g. Rheumatoid Arthritis) or current orthopaedic disorder in their spinal region or upper limbs, a history of neck or head surgery, a history of shoulder surgery in the past 12 months, a history of neurological disease resulting in altered sensation in upper quadrants as indicated by hypoesthesia to touch (unable to feel a 4.o gram Von Frey monofilament, presence of neuropathic pain (DN-4 score is 4 or greater), current self-reported psychiatric condition or psychological disorder other than mild to moderate depression or anxiety.

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)
The allocation will be recorded on dark, non-transparent cards, and inserted into opaque envelopes that will be numbered consecutively. Envelopes will be inserted in separate boxes for each gender. After baseline testing, the experimenter will open a sealed envelope, pre-prepared by a third party, containing the participant’s allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised allocation sequence will be generated using Microsoft excel by an experimenter not involved in data collection. A concealed stratified permuted block-randomized allocation approach will be employed, where participants are randomly allocated to the experimental or control group with a 2:1 ratio. To achieve low allocation predictability, while maintaining the allocation ratio, randomisation to group will occur in blocks of three (2:1) or six (4:2) allocations. The order of the blocks will also be randomised. Further, allocation sequences will be stratified by sex, to ensure equal proportions of males and females in each group.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The effect of training on tactile acuity, pain, and pain spread will be assessed using a mixed design ANOVA with one between group factor with two levels (Group: Intervention and Control) and one repeated factor with four levels (Time: baseline, mid-study, 5-week follow-up, and 2-month follow-up).

Feasibility data will be analysed descriptively and with respect to the a priori cut-off scores. These include: 1. A minimum intake of two participants per week and a positive recruitment rate of at least one participant intake out of every four invited, 2. An 80% treatment completion rate, 3. A follow-up rate of 70%, 4. A maximum of 10% missing data for primary and secondary outcomes for those that completed the study, 5. Adherence rates where at least two-thirds of participants complete over 50% of the prescribed training, 6. No statistically significant difference in credibility between intervention and control, a 7. Bangs blinding index of 0 ± 0.2 for both treatment arms as well as the outcome assessor (on a -1 to 1 scale, where scores closer to 0 represents being more unsure of group) 35-37, and 8. Neutral positive satisfaction with treatment ratings for both treatment arms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/06/2021
Actual
Date of last participant enrolment
Anticipated
3/01/2022
Actual
Date of last data collection
Anticipated
25/04/2022
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16843 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 30488 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 305887 0
Government body
Name [1] 305887 0
National Health and Medical Research Council
Country [1] 305887 0
Australia
Funding source category [2] 307936 0
Charities/Societies/Foundations
Name [2] 307936 0
Arthritis Australia
Country [2] 307936 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive, Southport, QLD 4222
Country
Australia
Secondary sponsor category [1] 306342 0
None
Name [1] 306342 0
Address [1] 306342 0
Country [1] 306342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306148 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 306148 0
Griffith University Human Research Ethics Committee
Parklands Drive, Southport, QLD 4222
Ethics committee country [1] 306148 0
Australia
Date submitted for ethics approval [1] 306148 0
18/07/2017
Approval date [1] 306148 0
06/09/2017
Ethics approval number [1] 306148 0
2017/128

Summary
Brief summary
Neck pain is related to a reduction in tactile acuity that may reflect disrupted sensory processing. Tactile acuity training may normalise sensory processing and improve symptoms. This proof-of-concept trial aims to investigate the efficacy of a novel tactile acuity training device for improving tactile acuity in people with chronic neck pain and inform feasibility of a larger study. We hypothesise that training will improve tactile acuity. Moreover, we hypothesise that training will result in positive changes in pain and pain spread.

This two-arm randomised clinical proof-of-concept trial will recruit participants with neck pain of at least six months duration, aged 18-75 years, receiving usual care physiotherapy in a secondary outpatient healthcare setting. Thirty-six consenting participants will be randomised 2:1 to receive four weeks of either tactile acuity training using the Imprint Tactile Acuity Device (iTAD), or a placebo intervention, in addition to usual care. Outcomes will be assessed at baseline, mid-treatment, and at 5-week and 2-month follow-up. The primary outcome tactile acuity will be evaluated using the two-point discrimination and locognosia tests. Feasibility will be informed by recruitment and attrition rates, adherence, treatment satisfaction and blinding. Pain intensity, anatomical spread of pain, and tactile acuity assessed using the iTAD, will be analysed as secondary outcomes. The effect of training on tactile acuity will be assessed using a 2 (Group: Intervention vs. Control) x 4 (Time: baseline, mid-treatment, 5-week and 2-month follow-up) mixed ANOVA. Secondary and exploratory outcomes will be analysed with a focus on informing outcomes and sample size in future trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102874 0
Dr Daniel Harvie
Address 102874 0
G05_2.44A Griffith University Gold Coast Campus
Parklands drive, Southport, QLD 4222
Country 102874 0
Australia
Phone 102874 0
+61 418826254
Fax 102874 0
Email 102874 0
[email protected]
Contact person for public queries
Name 102875 0
Dr Daniel Harvie
Address 102875 0
G05_2.44A Griffith University Gold Coast Campus
Parklands drive, Southport, QLD 4222
Country 102875 0
Australia
Phone 102875 0
+61 418826254
Fax 102875 0
Email 102875 0
[email protected]
Contact person for scientific queries
Name 102876 0
Dr Daniel Harvie
Address 102876 0
G05_2.44A Griffith University Gold Coast Campus
Parklands drive, Southport, QLD 4222
Country 102876 0
Australia
Phone 102876 0
+61 418826254
Fax 102876 0
Email 102876 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?
De-identified primary and secondary outcomes data.
When will data be available (start and end dates)?
Data will be available, following publication of the trial paper. This is expected to be April 2021. The data will be available for at least 5-years after publication.
Available to whom?
To other researchers.
Available for what types of analyses?
Meta-analyses and secondary data analyses
How or where can data be obtained?
Via the Griffith University research data repository or by request from the study investigators @ [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8168Study protocolProtocol will be published in an academic journal and is available on request from the study investigators. [email protected]
8169Informed consent form  [email protected] Informed consent form is available on request from... [More Details]
8170Ethical approval  [email protected] Proof of ethics approval is available on request f... [More Details]



Results publications and other study-related documents

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