Authors
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Griffith University -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: 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. CONDITION: Musculoskeletal ‐ Other muscular and skeletal disorders Persistent neck pain; ; Persistent neck pain PRIMARY OUTCOME: 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.[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. ] 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.[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.] Two‐point discrimination threshold (TPDT) assessed using digital sliding two‐point Vernier Calliper.[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.] SECONDARY OUTCOME: 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. [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.] 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. [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.] 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. [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.] 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.
Epistemonikos ID: e3dc4303fc3cafd567bf96095cb2c1b24dd2ebee
First added on: Aug 25, 2024