Does a Patient Education Focused on Pain Management Improve Disability, Pain Coping and Quality of Life in Patients With Low Back Pain and Psychosocial Risk Factors?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis in terms of quality of life, disability, sick leave and health care use. Despite existing literature showing that low back pain patients benefit from cognitive therapy interventions, this has not been investigated in subgroups of low back pain patients with psychosocial risk factors.
The purpose of the study is to investigate whether patients referred to secondary care with low back pain and coexisting psychosocial risk factors will have a better treatment outcome when participating in a pain management course in addition to usual care.
This will be investigated in a randomised study design, where 130 patients with chronic low back pain and psychosocial risk factors will be randomly allocated to either usual care or a cognitive-therapy based pain management intervention in addition to usual care.
The patients will be followed for one year after inclusion, and patientreported outcomes on disability, pain, sick leave, quality of life and pain coping will be collected by the use of questionnaires at baseline, 6 months and 12 months.
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
- Single (Investigator)
盲法说明
The invistigator performing the data analysis is unaware of group allocation. Due to the study design (pain management intervention versus usual care) it is not possible to blind patients and care providers.
Furthermore, as outcomes are selfreported, masking of assessors is not possible, as the patients are the assessors.
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
- •Non-specifick low back pain lasting ≥ 3 months
- •Psychosocial risk profile defined as a fear avoidance score >24 (Örebro Musculoskeletal Pain Questionnaire) and/or a bodily distress score >15 (Common Mental Disorder Questionnaire) and/or health anxiety score >9 (Common Mental Disorder Questionnaire)
- •Speaks and understands Danish
- •Age ≥ 18 years
排除标准
- •Inflammatory or malignant disease
- •Spine surgery within the last year
- •Untreated or severe depression
- •Psychiatric course of treatment within the last year
- •Abuse of drugs or alcohol
- •Pregnancy
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: Change from baseline to 12 months after baseline
The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).
次要结局
- Low Back Pain Rating Scale - Back pain(Change from baseline to 12 months after baseline)
- EuroQol 5 Dimensions(Change from baseline to 12 months after baseline)
- Low Back Pain Rating Scale - Leg pain(Change from baseline to 12 months after baseline)
- Pain Catastrophizing Scale(Change from baseline to 12 months after baseline)
- Sick leave(Change from baseline to 12 months after baseline)