The iSTOPP study: Protocol for a proof-of-concept randomised clinical trial of sensory discrimination training in people with persistent neck pain

BACKGROUND: Neck pain can be associated with a reduction in tactile acuity that is thought to reflect disrupted sensory processing. Tactile acuity training may normalise sensory processing and improve symptoms. This proof-of-concept trial will assess the feasibility of a novel tactile acuity training method and whether this intervention improves tactile acuity in people with persistent neck pain. METHODS: and analysis: In this two-arm randomised clinical proof-of-concept trial we will recruit participants with neck pain receiving usual care physiotherapy in a secondary outpatient healthcare setting. Thirty-six 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. The placebo intervention will consist of a de-activated TENS machine (iTENS) said to deliver a sub-threshold inhibitory therapy. Outcomes will be assessed at baseline, mid-treatment, and at 5-weeks and 2-months follow-up. The primary outcome tactile acuity will be evaluated using the two-point discrimination test and locognosia tests. Feasibility will be informed by recruitment and attrition rates, adherence, credibility of the interventions, treatment satisfaction and blinding. Pain intensity and anatomical spread will be analysed as secondary outcomes. The effect of iTAD training on tactile acuity will be assessed using a 2 (Group: iTAD vs. iTENS) x 4 (Time: baseline, mid-treatment, 5-week and 2-month outcome assessment) mixed ANOVA. Secondary outcomes including pain and pain spread, will be analysed with a focus on informing sample size calculations in future trials. ETHICS AND DISSEMINATION: Risks associated with this study are minor. Usual care is not withheld, and participants consent to random allocation of either iTAD or iTENS. Potential benefits to participants include any benefit associated with the interventions and contributing to research that may assist people with chronic pain in the future. Trial results will be disseminated via academic journals and conference presentations. The study is approved by the Human Research Ethics Committee of Griffith University (2017/128).