跳至主要内容
临床试验/NCT06523036
NCT06523036已完成不适用

Integrating Chiropractic Care and Mind-Body Training for the Treatment of Nonspecific Chronic Neck Pain in Nurses

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Retention

研究概览

简要总结

Chronic neck pain is particularly prevalent among nurses. Nurses experiencing neck pain frequently report its impacts including decreased job satisfaction and reduced productivity. In recent years, non-pharmacologic approaches have increasingly been used treatments for the management of neck pain. Exercise and manual therapies represent two of the most common non-pharmacologic interventions for pain. The purpose of this study was to perform a pilot study of combined multimodal chiropractic care and Tai Chi for neck pain in nurses to help inform the design of a future, full-scale pragmatic trial.

详细描述

The lifetime prevalence of chronic neck pain is approximately 50%, and it is associated with substantial societal and individual burden. Neck pain is prevalent among healthcare workers, specifically among nurses. About 45% of nurses experience neck pain, but rates may vary by population and nursing type. Neck pain in nurses significantly contributes to sickness absence and negatively impacts nurses' productivity and performance at work. Neck pain is a burden on nurses' individual health and on the healthcare system as a whole. Two of the most common non-pharmacological approaches for the management of neck pain are exercise and manual therapies, and there is some evidence that multimodal approaches combining the two are more effective than unimodal strategies. Given the widespread availability in most metropolitan areas of both Tai Chi and chiropractic care, development of an evidence-based care regimen integrating Tai Chi mind-body self-care with chiropractic represents a practical strategy for management of neck pain.

To help inform the design of a larger-scale trial evaluating the combined effects of Tai Chi and chiropractic care for neck pain, the investigators propose to conduct a single-arm pilot study to evaluate the feasibility of delivering coordinated chiropractic care and Tai Chi via community-practitioners for nurses at Mass General Brigham Hospitals with chronic neck pain. 21 nurses with chronic neck pain that meet all study eligibility criteria will be recruited to receive 10 chiropractic treatments and weekly Tai Chi training over 16 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Nurses employed at Mass General Brigham Hospitals
  • Chronic nonspecific neck pain at least 5 days a week for at least 3 consecutive months
  • Neck pain level of 3 or higher as reported on a numerical scale ranging from 0 to 10, with 10 described as 'worst neck pain imaginable'
  • Agreeable to participate and commit to study interventions
  • Neck Disability Index score of 5 or greater
  • Fluent in English

排除标准

  • Currently, or having received chiropractic care in past 12 months
  • Regular practice (on average, weekly) of Yoga, Tai Chi or Qigong in the past 6 months
  • Any major systemic illness or unstable medical or psychiatric condition requiring immediate treatment or that could lead to difficulty complying with the protocol
  • Any disability precluding exercise practice
  • History of stroke, carotid artery dissection, or vertebral artery dissection
  • Signs of myelopathy or carotid bruits or evidence of pathological hypermobility (e.g. Ehlers Danlos Syndrome) during the clinical exam
  • Neck pain caused by congenital deformity of the spine that contraindicate treatment, neck pain related to neoplasm, inflammatory rheumatic disease, neurological disorder, active oncologic disease, severe affective disorder, addiction, or psychosis
  • Neck pain associated with radicular pain or radiculopathy
  • Pregnancy
  • Recent spinal injections (in the past 4 weeks)
  • Neck pain with litigation, any prior cervical surgery/spinal surgery within previous year
  • Persons currently involved in a disability/accident claim

结局指标

主要结局

Retention

时间窗: 16 weeks

Percentage of participants who completed the 16-week intervention and follow-up measures.

Recruitment

时间窗: 6 months

Rate of enrollment (number of interested participants/number enrolled) and the percentage of eligible participants who consented to participate.

Adherence to interventions

时间窗: 16 weeks

Proportion of participants who attend 70% of the chiropractic visits and 60% of the weekly Tai Chi classes.

次要结局

  • Pain Severity(Assessed at baseline and at week 16.)
  • Patient Reported Outcome Measures Information System 29 (PROMIS-29)(Assessed at baseline and at week 16.)
  • Neck Disability Index (NDI)(Assessed at baseline and at week 16.)
  • Bothersomeness of Pain(Assessed at baseline and at week 16.)
  • Generalized Self-Efficacy Scale (GSES)(Assessed at baseline and at week 16.)
  • Hospital Anxiety and Depression Scale(Assessed at baseline and at week 16.)
  • Tampa Scale for Kinesiophobia(Assessed at baseline and at week 16.)
  • Stanford Presenteeism Scale, 6-item version (SPS-6)(Assessed at baseline and at week 16.)
  • Pain on Movement (POM)(Assessed at baseline and at week 16.)
  • Maslach Burnout Inventory (MBI)(Assessed at baseline and at week 16.)
  • Multidimensional Assessment of Interoceptive Awareness (MAIA)(Assessed at baseline and at week 16.)
  • Postural Awareness Scale(Assessed at baseline and at week 16.)
  • Trail Making Test II(Assessed at baseline and at week 16.)
  • Gait Speed(Assessed at baseline and at week 16.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter M. Wayne, Ph.D.

Associate Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

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