Behavioral Medicine Treatment for Adolescents in Pain
Development, Evaluation and Cost Effectiveness of a Treatment Program With a Behavioural Medicine Approach for Adolescents With Persistent Pain.
Recurrent pain, such as headache, stomach pain and musculoskeletal pain is common in children and adolescents. Children and adolescents are reported to have restrictions in daily life activities, social contacts, and school attendance, and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems. The treatment approaches available today for teenagers with pain are often biological/physiological and little evidence for their effectiveness has been shown. It is urgent to try new interventions for pain problems in early ages in order to prevent disability, development of maladaptive coping strategies and to avoid negative impact on daily activities.
The optimal treatment regime for paediatric pain patients has been suggested to be cognitive behavioural approach integrated with physical therapy The aim of this project is to develop and evaluate in a randomized controlled trial a treatment program with a behavioural medicine approach (suitable to use in primary care or school based health care context) compared with standard treatment for adolescents with persistent pain problems. The aim is also to compare short and long-term costs for patients and for the health care system related to the two interventions, in order to determine strategies for future cost-effective care of children and adolescents experiencing recurrent pain.
研究概览
详细说明
Chronic or recurrent pain symptoms are widely studied and generally regarded as an important public health concern in adults. The prevalence of pain symptoms are reported to be as high as 25-30 % in children and adolescents. Children and adolescents are reported to have restrictions in daily life activities, social contacts, and school attendance, and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems. These patients suffer from a wide variety of problems, for example sports injuries, persistent postoperative pain, musculoskeletal pains, headaches or multiple recurrent pain problems. The treatments given today to adolescents are dealing with symptoms in a physical manner.
In this study participants will be recruited among adolescents referred to paediatric physiotherapy. The participants will be randomly allocated to either physiotherapy including standard treatment or a behavioural medicine treatment program. Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis.
The behavioural medicine treatment program will include the same components as the standard treatment with the addition of age appropriate interventions aimed to address the emotional and behavioural processes of pain. The treatment is based on earlier intervention programs and includes the following phases;
- Individual functional behavioural analysis The adolescents lists specific important and frequent activities and situations they have problems to master due to pain and target activities are then chosen. Individual capabilities (both physical and psychological), behavioural responses, and their short and long-term consequences are identified. Parental responses and their impact on adolescent's pain behaviours are noted. Target activity related treatment goals as well goals for engagement in the treatment are defined from the individual functional behavioural analysis.
- Basic skill acquisition Physical abilities and cognitive skills required for improvement of behaviour in target activities are trained. For example to meet the problem of fear of movement, graded activity, or exposure will be provided. When negative thoughts are recognized the adolescents are taught and trained on how to replace these thoughts, self-efficacy for target activities are increased by carefully selected activities witch allows the adolescent to succeed and by repeated feedback from the physiotherapists. Adequate coping strategies for restoring and sustaining activities are taught and trained. Parents are trained on how to support new behaviours.
- Applied skill acquisition The basic capabilities are put together in order to shape the more complex skills required when applying in target activities. Self- efficacy is reinforced by feedback from both the physiotherapists and parents.
- Generalisation This phase includes the generalisation of new, both physical and psychological skills to other, for the adolescent important, activities.
- Maintenance and relapse prevention This phase includes the identification of "risk situations", and recognition of how adolescents and parents can support positive behaviours further.
Patient follow-ups takes place immediately after completed intervention, after 6 months and after one year and two years after intervention in order to evaluate the long-term effect.
• Parents The treatment is based on earlier intervention program and includes; Information on pain and pain behaviours and parental impact on adolescent's pain behaviours. An individual intervention plan according to each teenager's problems is made. All parents will be trained on how to support new positive health behaviours.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Uppsala、瑞典、75125
- Samariterhemmet
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adolescents with pain and interference of daily activities due to pain, referred to paediatric physiotherapy in a primary health setting will be included.
- Participants must understand written and oral Swedish and have had persistent pain for more than 6 weeks or recurrent pain more than once a week for over three months.
- The adolescents´ parents will be included in a brief intervention.
Exclusion Criteria:
- Subjects with resent trauma, ongoing treatment for any psychiatric illness or cognitive problems will be excluded.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Behavioural medicine
|
The behavioural medicine treatment program will include muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis and age appropriate interventions aimed to address the emotional and behavioural processes of pain.
|
|
有源比较器:Standard treatment
Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis
|
Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Functional Disability Inventory
大体时间:6 months, one year and 2 years post treatment
|
Functional Disability Inventory assesses children's self reported difficulties in physical and psychosocial functioning due to the child's physical health.
FDI consists of 15 items describing limitations of activities during the past two weeks.
Each item is scored on a 5-point (0-4) where a higher score indicates greater disability.
The FDI has been reported to have a high validity and reliability and can be used for children and adolescents with recurrent and chronic pain.
|
6 months, one year and 2 years post treatment
|
合作者和调查者
调查人员
- 首席研究员:Anne Söderlund, Professor、Uppsala University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Dnr 2010/047
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.