Evaluation of Implementation and Effectiveness of Neck-specific Exercise for Persistent Disability and Pain After Whiplash Injury; a Randomized Controlled Study Using a Hybrid II Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Implementation - Adoption of neck-specific exercise programmes
研究概览
简要总结
Persistent pain and disability in whiplash-associated disorders (WAD) grade II and III are common. Randomized controlled studies (RCTs) have shown promising result for neck-specific exercise (NSE) programmes in chronic WAD with clinically and statistically significant improvement in pain and disability. Neck-specific exercise with internet support (NSEIT) and four visits to a physiotherapist was non-inferior to NSE at a physiotherapist clinic 2 times a week in 12 weeks (24 visits). The aims of the proposed study are to evaluate an implementation strategy for NSE and NSEIT in primary health care and to evaluate the effectiveness of NSE and NSEIT in clinical practice.
详细描述
The study is a prospective cluster-randomized study with hybrid II trial design.
In total will 20 physiotherapy clinics in primary health care be recruited. Reg. physiotherapists working in the twenty physiotherapy clinics will be included. The clinics will be randomised to two groups with different implementation strategy: (A, intervention) three theoretical on-line lectures and the three hours' practical training with additional support; (B, control) the same education and practical training as A but with no additional support. Twenty-five patients with neck pain will be consecutively recruited from each clinic, a total of 500 patients. Outcome measurements will be conducted at baseline, 3- and 12-months.
This trial will evaluate the implementation strategy in terms of adoption of and adherence to NSEIT and NSE in clinical primary health care, also measuring diffusion of the method to other neck pain patients. In parallel, effectiveness of the exercises are evaluated.
All analyses will be conducted in collaboration with a statistician using parametric or non-parametric statistics depending on the type of data.
- The implementation strategy will be analyzed using parametric t-test and a linear mixed model Analysis of Variance (ANOVA) or non-parametric Mann-Whitney U test and Kruskal-Wallis to evaluate differences between group A and B and change in variables over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •implementation
- •- Reg. physiotherapists working in twenty physiotherapy clinics in primary health care.
排除标准
- •implementation
- •- No exclusion criterta
- •Inclusion criteria to evaluate the effectiveness of neck-specific exercise
- •The physiotherapists will include patients ≥ 18 years with neck pain.
- •Patients are required to have internet access by phone, tablet, or computer
- •Be able to read and understand Swedish
- •Exclusion criteria:
- •Physiotherapists should exclude patients with "red flags"i.e., symptoms that suggest a serious illness or spinal abnormality.
- •Serious trauma to the neck and no X-ray
- •Preceding neck surgery
- •Osteoporosis
- •Myelopathy
- •History of cancer
- •Unexplained weight loss
- •Present fever, history of infections
- •Constant and progressive non-mechanical pain
- •Insidious progression of pain
- •Signs of spinal cord compression (neurological examination to exclude spinal cord or cervical myelopathy such as clumsy hands, altered gait, or disturbances of sexual, bladder or sphincter function).
结局指标
主要结局
Implementation - Adoption of neck-specific exercise programmes
时间窗: Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics)
Proportion of patients with neck pain receiving neck-specific exercise
Patient Effectiveness - Neck Disability Index
时间窗: Change from baseline to 3 months (after treatment) and 12 months follow-up
Self-reported neck-specific function
次要结局
- Patient - Pain intensity (current, average last week, worst pain last week) in neck, head, and arm, and dizziness (current, average last week, worst dizziness last week)(Change from baseline to 3 months (after treatment) and 12 months follow-up)
- Patient - Workability(Change from baseline to 3 months (after treatment) and 12 months follow-up)
- Implementation - The Evidence-Based Practice Attitude Scale (EBPAS)(Baseline)
- Implementation - Practitioner Confidence Scale (PCS)(Change from baseline to 3 months (after treatment) and 12 months follow-up)
- Patient - rating of self-perceived health(Change from baseline to 3 months (after treatment) and 12 months follow-up)
- Patient - The patient's assessment of perceived anxiety and depression(Change from baseline to 3 months (after treatment) and 12 months follow-up)
- Patient - Improvement or deterioration over time(Measured at 3 months and 15 months follow up)