Harvie Daniel S, Olthof Nick, Hams Andrea, Thomson Hayley, Coppieters Michel W
Menzies Health Institute Queensland, Griffith University, Brisbane and Gold Coast, Australia.
School of Allied Health Sciences and Social Work, Griffith University, Brisbane and Gold Coast, Australia.
Contemp Clin Trials Commun. 2021 Jul 14;23:100820. doi: 10.1016/j.conctc.2021.100820. eCollection 2021 Sep.
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.
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.
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).
颈部疼痛可能与触觉敏锐度降低有关，这被认为反映了感觉处理过程的中断。触觉敏锐度训练可能会使感觉处理正常化并改善症状。这项概念验证试验将评估一种新型触觉敏锐度训练方法的可行性，以及这种干预措施是否能改善持续性颈部疼痛患者的触觉敏锐度。
在这项双臂随机临床概念验证试验中，我们将招募在二级门诊医疗环境中接受常规护理物理治疗的颈部疼痛患者。36名参与者将按2:1随机分组，除常规护理外，分别接受为期四周的使用印记触觉敏锐度设备（iTAD）的触觉敏锐度训练或安慰剂干预。安慰剂干预将包括一台已停用的经皮电刺激神经疗法（TENS）机器（iTENS），据说它能提供阈下抑制疗法。将在基线、治疗中期、5周和2个月随访时评估结果。主要结果触觉敏锐度将使用两点辨别试验和位置觉测试进行评估。招募率和损耗率、依从性、干预措施的可信度、治疗满意度和盲法将为可行性提供参考。疼痛强度和解剖扩散将作为次要结果进行分析。iTAD训练对触觉敏锐度的影响将使用2（组：iTAD与iTENS）×4（时间：基线、治疗中期、5周和2个月结果评估）混合方差分析进行评估。包括疼痛和疼痛扩散在内的次要结果将进行分析，重点是为未来试验中的样本量计算提供参考。
与本研究相关的风险较小。不停止常规护理，参与者同意随机分配接受iTAD或iTENS。对参与者的潜在益处包括与干预措施相关的任何益处，以及为可能有助于未来慢性疼痛患者的研究做出贡献。试验结果将通过学术期刊和会议报告进行传播。该研究已获得格里菲斯大学人类研究伦理委员会的批准（2017/128）。
