Behavioral Medicine Treatment for Adolescents in Pain
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 20, 2010 | ||||||||
| Last Updated Date | June 23, 2011 | ||||||||
| Start Date ICMJE | January 2011 | ||||||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in Functional Disability Inventory [ Time Frame: 6 months, one year and 2 years post treatment ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01381263 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Behavioral Medicine Treatment for Adolescents in Pain | ||||||||
| Official Title ICMJE | Development, Evaluation and Cost Effectiveness of a Treatment Program With a Behavioural Medicine Approach for Adolescents With Persistent Pain. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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;
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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 12 Years to 16 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01381263 | ||||||||
| Other Study ID Numbers ICMJE | Dnr 2010/047 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Anne Söderlund, professor, University of Uppsala Department of Neuroscience | ||||||||
| Study Sponsor ICMJE | Uppsala University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Uppsala University | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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