None listed
Conditions
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.
Interventions
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
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.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed