Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Global Rating of Change (GROC) scale
研究概览
简要总结
The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. The research group will receive neck exercise program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. In addition, clinical prediction rule (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment program will be defined.
详细描述
Background:Recently, Hanney et al (2013) derived a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise-based treatment program. These CPRs of neck exercise has not considered aerobic exercise (AE) on NP treatment.
Aims of this study: 1) To investigate the effect of aerobic exercise on chronic neck pain;2) To derive a clinical prediction rule for identifying patients with neck pain who may benefit from aerobic treatment program; 3) To determine the prevalence of neck pain in Israel.
Study Design: Double Blind Randomized controlled trial setting: Outpatients physical therapy clinics of "Clalit Health Services" in Haifa and Western Galilee area.
Participants: Patients referred to physical therapy with a primary diagnosis of chronic non-specific NP.
Methods: Following a baseline examination in which the subjects' status on the CPR will be determined, the subjects (CPR positive and negative) will be randomized, divided into a research group and control group. The CPR status will be determined according to Hanney's paper (e.g.: neck disability Index score < 18/50 ,shoulder protraction, cervical side bending < 32°,Fear avoidance belief questionnaire-physical activity score < 15, not active on a regular basis on bicycle training). Positive CPR is accordance of having 4/5 these points.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic neck pain (> 30 days)
- •neck disability index >10
- •not physical active on a daily basis
排除标准
- •past history of whiplash injury or cervical surgery
- •pain radiates to the upper limb with neurological deficit (reduced reflex, sensation, muscle strength)
- •complain of vertigo
- •cervical spine diseases: Spondylosis, Spondylolisthesis
研究组 & 干预措施
positive CPR: research group
physical therapy treatment with aerobic exercise
干预措施: physical therapy treatment with aerobic exercise (Other)
negative CPR: research group
physical therapy treatment with aerobic exercise
干预措施: physical therapy treatment with aerobic exercise (Other)
positive CPR: control group
physical therapy treatment
干预措施: physical therapy treatment (Other)
negative CPR: control group
physical therapy treatment
干预措施: physical therapy treatment (Other)
结局指标
主要结局
Global Rating of Change (GROC) scale
时间窗: following 6 weeks of treatment, 3 months and 6 months
rating pain severity on a scale from -7 to 7
次要结局
- long term follow up assessment Neck Disability Index(3 months and 6 months)
- Change from baseline in Visual Analog Scale (VAS) at 6 weeks(following 6 weeks of treatment)
- headache complaints(following 6 weeks of treatment, 3 months and 6 months)
- long term follow up assessment of VAS(3 months and 6 months)
- Change from baseline in Neck Disability Index at 6 weeks(following 6 weeks of treatment)
- Change from baseline in Fear Avoidance Beliefs Questionnaire(following 6 weeks of treatment)
- Change from baseline in cervical range of motion(following 6 weeks of treatment)
- medication consumption for pain relief(following 6 weeks of treatment, 3 months and 6 months)
研究者
Prof. Refael Carel
Professor
Clalit Health Services