A Stratified Approach Integrated With eHealth in Primary Care Physiotherapy for Patients With Neck and/or Shoulder Complaints
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Neck pain and disability score (NPAD; for patients with neck pain)
研究概览
简要总结
The aim of this cluster RCT is to investigate the clinical effectiveness of a Stratified Blended Approach for patients with neck and/or shoulder complaints on pain and disability over 9 months, compared to usual physiotherapy care.
Our secondary aims are twofold:
- to investigate the effectiveness of the Stratified Blended Approach for patients with neck and/or shoulder complaints on pain intensity, health-related quality of life, illness perceptions, self-management skills, physical activity, exercise adherence, self-perceived effect and satisfaction at 3 and 9 months, compared to usual physiotherapy care;
- to investigate the cost-effectiveness and cost-utility of the Stratified Blended Approach for patients with neck and/or shoulder complaints, compared to usual physiotherapy care.
In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual.
This study is financially supported by the Scientific College Physiotherapy (WCF), part of the Royal Dutch Association for Physiotherapy (KNGF). WCF has no role in study design, data collection and analysis, decision to publish, or preparation of the manuscripts. External peer-review took place during the funding process. The results will be publicly disclosed unreservedly.
详细描述
Intervention:
According to the Stratified Blended approach, patients will be matched to an appropriate treatment based on their risk of persistent disabling pain (assessed with the Keele STarT MSK Tool - either low, medium or high risk) and their suitability for blended care (assessed with the Dutch Blended Physiotherapy Checklist - either suitable or unsuitable for blended care). Based on patients risk profile, the physiotherapy treatment will be targeted to patients' individual needs. If considered suitable for blended care, the patient will receive a digital and face-to-face blend of physiotherapy treatment (e-Exercise) in which an app with personalized information, exercises and physical activity modules is integrated with face-to-face physiotherapy care. If patients are considered unsuitable for blended care, they will receive an information workbook with similar content as the app will be integrated with face-to-face physiotherapy. The app and the information workbook aims to support adherence to physical activity and exercise recommendations. Content of care was based on the Dutch KNGF Clinical Practice Guidelines for Physiotherapy Neck pain, Complaints of Arm, Neck and Shoulder (CANS) and Subacromial complaints.
Control group:
Usual physiotherapy. Content of care was based on the Dutch KNGF Clinical Practice Guidelines for Physiotherapy Neck pain, Complaints of Arm, Neck and Shoulder (CANS) and Subacromial complaints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the intervention, blinding of participating physiotherapists is not possible. However, neither physiotherapists nor patients in the usual physiotherapy care arm will be informed about the Stratified Blended Approach arm.
During the analyses, the researchers will be blinded to group allocation until the entire analysis will be completed.
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
- •Patients with neck and/or shoulder complaints will be recruited within participating physiotherapy practices. In order to be eligible to participate in the data collection for the trial, a patient must meet all of the following criteria:
- •consulting for physiotherapy for neck and/or shoulder complaints;
- •one of the following physiotherapeutic diagnoses: subacromial complaints, biceps tendinosis, shoulder instability or non-specific musculoskeletal complaints of the neck and/or shoulder (not caused by acute trauma (fracture or rupture) or by any systemic disease);
- •18 years or older;
- •sufficient mastery of the Dutch language.
排除标准
- •A patient who meets any of the following criteria will not be suitable to take part in the data collection for the trial:
- •neck and/or shoulder complaints caused by specific pathology (e.g. shoulder pain with loss of active and passive range of motion (frozen shoulder), vertebral fracture, tendon rupture, Parkinson's disease, hernia nucleus pulposus, cervical stenosis), except for subacromial impingement, biceps tendinosis and shoulder instability.
结局指标
主要结局
Neck pain and disability score (NPAD; for patients with neck pain)
时间窗: 9 months
The primary outcome is the combined region-specific pain and disability score over 9 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.
Shoulder pain and disability index (SPADI; for patients with shoulder pain)
时间窗: 9 months
The primary outcome is the combined region-specific pain and disability score over 9 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.
次要结局
- Global perceived effect(9 months)
- Satisfaction with treatment(3 months)
- Neck pain and disability score (NPAD; for patients with neck pain)(3 months)
- Illness perceptions(9 months)
- Patients' self-management skills(9 months)
- Physical activity(9 months)
- Neck and/or shoulder pain intensity(9 months)
- Exercise adherence(9 months)
- Cost-effectiveness (assessed with a cost questionnaire)(9 months)
- Cost-utility (assessed with a cost questionnaire)(9 months)
- Health-related quality of life(9 months)
- Shoulder pain and disability index (SPADI; for patients with shoulder pain)(3 months)
研究者
Mark van Tilburg
Investigator
University of Applied Sciences Utrecht