Department of Environmental Medicine, Division of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Nobels väg 13, S-, 171 77, Stockholm, Sweden.
Division of Biostatistics, Karolinska Institutet, Nobels väg 13, S-, 171 77, Stockholm, Sweden.
BMC Musculoskelet Disord. 2021 Oct 27;22(1):903. doi: 10.1186/s12891-021-04772-x.
Recurrent or persistent neck pain affects a vast number of people globally, leading to reduced quality of life and high societal costs. Clinically, it is a difficult condition to manage, and treatment effect sizes are often moderate at best. Activity and manual therapy are first-line treatment options in current guidelines. We aimed to investigate the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in multidiscipline ary primary care clinics.
The treatment modalities utilized were spinal manipulative therapy and home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS - 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively. One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both group and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used.
Sixty-six subjects were randomized to the intervention group, and sixty-five to the control group. For NRS - 11, a B-coefficient of - 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures.
Based on the current findings, there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain.
The trial was registered 03/07/2018 at ClinicalTrials.gov , registration number: NCT03576846.
全球有大量的人受到反复发作或持续性颈部疼痛的影响,导致生活质量下降,社会成本增加。临床上,这种疾病很难治疗,治疗效果往往最多也就是中等水平。在当前的指南中,活动和手动治疗是一线治疗选择。我们旨在调查家庭拉伸运动与脊柱推拿疗法相结合在多学科初级保健诊所进行的多中心随机对照临床试验中的效果。
所使用的治疗方式是脊柱推拿疗法和家庭拉伸运动,与单纯的家庭拉伸运动进行对比。两组都接受了为期 2 周、共 4 次的治疗。主要结局是疼痛,通过评估疼痛强度(NRS-11)和疼痛质量(麦吉尔疼痛问卷)来评估主观疼痛体验。颈部残疾和健康状况是次要结局,分别使用颈部残疾指数和 EQ-5D 进行测量。131 名成年受试者被随机分配到两个治疗组中的一个。所有受试者在前 6 个月都经历过持续性或复发性颈部疼痛,并且对另一组的干预措施不知情。临床医生为两组中的受试者提供治疗,且不能对另一组的干预措施进行盲法。收集数据的研究人员对治疗分配不知情,进行数据分析的统计人员也不知情。采用意向治疗分析。
66 名受试者被随机分配到干预组,65 名受试者被随机分配到对照组。对于 NRS-11,我们看到 B 系数为-0.01,这表明干预组在每个时间点相对于对照组的改善为 0.01,p 值为 0.305。在任何结果测量指标中,两组之间均无统计学显著差异。
根据目前的研究结果,对于持续性或复发性颈部疼痛患者,在 2 周内,在颈部拉伸运动的基础上增加脊柱推拿疗法并没有额外的治疗效果。
该试验于 2018 年 3 月 7 日在 ClinicalTrials.gov 注册,注册号为:NCT03576846。