The Long-term Effect of an Outpatient Intervention Program With a Behavioral Therapy Approach in Patients With Chronic Back or Neck Pain With a Focus on Psychosocial Aspects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
To investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.
详细描述
BACKGROUND: Sustained success of ambulant intervention programs consisting of individual and group physiotherapy in patients with with chronic unspecific back or neck pain (cBP) has not been conclusively proven. It's still not clear whether one can achieve such success by devoting greater attention to psychosocial factors.
OBJECTIVE
We investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on cBP. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.
DESIGN: Prospective, randomized controlled trial
SETTINGS, INTERVENTION: 64 patients were assigned to intervention group (IG) and 57 to control group (CG). All were examined, informed about cBP, and were encouraged to stay active and perform exercises according to specific instructions provided in a neck- or back-book. The IG received 9 units of physiotherapy and 2 units of occupational therapy, conducted with a behavioral therapy approach. Efficacy of treatment was evaluated after 6 and 58 weeks.
MEASUREMENTS: Pain (VAS), quantity of painkillers consumed, sick leave days, Oswestry-Disability-Index (ODI), SF-36, FABQ.
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minimum age 18 years, maximum age: men 55 years, women 50 years.
- •the patients had been on sick leave for a minimum of 4 and a maximum of 22 days during the preceding 12 months because of nonspecific spinal symptoms in the back or neck.
- •The patients had to be working at the start of the study.
排除标准
- •Specific causes of spinal symptoms (after spinal surgery, known vertebral body fractures, disk prolapse with motor deficits or other radicular lesions, tumor, osteomyelitis, spondylodiscitis, rheumatic disease, osteoporosis).
- •Retired persons, those in the process of being screened for retirement, unemployed persons,
- •pregnancy or persons on maternity leave
- •Planned surgery during the phase of intervention
- •persons who were unable to participate in the intervention program for other reasons (physical, psychological, linguistic or organizational).
结局指标
主要结局
Pain
时间窗: After 0 / 6 / 58 Weeks
To evaluate the main hypothesis, current pain and mean pain during the preceding week and the preceding 3 months were determined on a visual analog scale (VAS; 0-100, lower scores indicate less severe pain)
次要结局
- Fear avoidance behavior(After 0 / 6 / 58 weeks)
- Social function, psychological wellbeing and emotional role function(After 0 / 6 / 58 weeks)
- Functional impairment(After 0 / 6 / 58 weeks)
- Anxiety, insecurity in social contacts and compulsiveness(After 0 / 6 / 58 weeks)
- Painkillers(After 0 / 58 weeks)
- Sick leave days(After 0 / 58 weeks)
研究者
Florian Wepner
Dr.
Orthopedic Hospital Vienna Speising