Data from: Chiropractic treatment including instrument-assisted manipulation for non-specific dizziness and neck pain in community-dwelling older people: a feasibility randomised sham-controlled trial

The protocol and the datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Abstract

Background

Dizziness in older people is a risk factor for falls. Neck pain is associated with dizziness and responds favourably to neck manipulation. However, it is unknown if chiropractic intervention including instrument-assisted manipulation of the neck in older people with neck pain can also improve dizziness.

Methods

This parallel two-arm pilot trial was conducted in Melbourne, Australia over nine months (October 2015 to June 2016). Participants aged 65–85 years, with self-reported chronic neck pain and dizziness, were recruited from the general public through advertisements in local community newspapers and via Facebook. Participants were randomised using a permuted block method to one of two groups: 1) Activator II™-instrument-assisted cervical and thoracic spine manipulation plus a combination of: light massage; mobilisation; range of motion exercises; and home advice about the application of heat, or 2) Sham-Activator II™-instrument-assisted manipulation (set to zero impulse) plus gentle touch of cervical and thoracic spinal regions. Participants were blinded to group allocation. The interventions were delivered weekly for four weeks. Assessments were conducted one week pre- and post-intervention. Clinical outcomes were assessed blindly and included: dizziness (dizziness handicap inventory [DHI]); neck pain (neck disability index [NDI]); self-reported concerns of falling; mood; physical function; and treatment satisfaction. Feasibility outcomes included recruitment rates, compliance with intervention and outcome assessment, study location, success of blinding, costs and harms.

Results

Out of 162 enquiries, 24 participants were screened as eligible and randomised to either the chiropractic (n = 13) or sham (n = 11) intervention group. Compliance was satisfactory with only two participants lost to follow up; thus, post-intervention data for 12 chiropractic intervention and 10 sham intervention participants were analysed. Blinding was similar between groups. Mild harms of increased spinal pain or headaches were reported by 6 participants. Costs amounted to AUD$2635 per participant. The data showed a trend favouring the chiropractic group in terms of clinically-significant improvements in both NDI and DHI scores. Sample sizes of n = 150 or n = 222 for dizziness or neck pain disability as the primary outcome measure, respectively, would be needed for a fully powered trial.

Conclusions

Recruitment of participants in this setting was difficult and expensive. However, a larger trial may be feasible at a specialised dizziness clinic within a rehabilitation setting. Compliance was acceptable and the outcome measures used were well accepted and responsive.

本研究中使用和/或分析的实验方案与数据集，可通过通讯作者提出合理申请后获取。

摘要

背景
老年眩晕是跌倒的危险因素。颈痛与眩晕存在关联，且对颈部手法操作反应良好。但目前尚不明确，针对伴慢性颈痛的老年人群实施包括器械辅助颈部操作在内的脊椎按摩疗法（chiropractic）干预，是否同样能够改善眩晕症状。

方法
本研究于2015年10月至2016年6月在澳大利亚墨尔本开展，为期9个月，为平行双臂预试验。通过当地社区报纸广告及Facebook平台面向公众招募受试者，纳入65~85岁、自我报告患有慢性颈痛及眩晕的人群。采用区组随机化法将受试者分为两组：①Activator II™器械辅助颈椎与胸椎手法操作，联合轻按摩、关节松动术、关节活动度训练及居家热敷指导；②假Activator II™器械辅助操作（设置为零冲量），联合颈椎与胸椎区域轻柔触诊。所有受试者均对分组分配设盲。干预方案每周实施1次，共持续4周。分别于干预前1周与干预后1周开展评估。采用盲法评估的临床结局指标包括：眩晕（眩晕残障量表[Dizziness Handicap Inventory, DHI]）、颈痛（颈部残疾指数[Neck Disability Index, NDI]）、自我报告的跌倒担忧、情绪状态、身体功能及治疗满意度。可行性结局指标则涵盖招募率、干预与结局评估依从性、研究开展地点、盲法实施成功率、成本及不良事件。

结果
在162份咨询申请中，共24名受试者通过资格筛查，被随机分配至脊椎按摩疗法（chiropractic）干预组（n=13）或假干预组（n=11）。干预依从性良好，仅2名受试者失访，最终共纳入12名脊椎按摩干预组与10名假干预组受试者的干预后数据进行分析。两组的盲法效果相当。共有6名受试者报告了轻微不良事件，表现为脊柱疼痛加重或头痛。每位受试者的干预成本约为2635澳元。数据显示，在NDI与DHI评分的临床显著改善方面，脊椎按摩干预组呈现出更优的趋势。若以眩晕或颈痛残疾作为主要结局指标，则效能充足的正式试验分别需要纳入150名或222名受试者。

结论
本研究场景下的受试者招募既困难且成本高昂。不过，在康复机构内的专科眩晕诊所开展更大规模的试验或许具备可行性。本研究的干预依从性尚可，所采用的结局指标也获得了良好的接受度与响应性。