Exploring Integrative Medicine in Swedish Primary Care
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | November 28, 2007 | ||||
| Last Updated Date | November 28, 2007 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Pain, disability, stress, wellbeing, use of analgesics and health care [ Time Frame: At 12 weeks, 16 weeks and after 18 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Health related quality of life [ Time Frame: At 12 weeks, 16 weeks and after 18 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Exploring Integrative Medicine in Swedish Primary Care | ||||
| Official Title ICMJE | Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial | ||||
| Brief Summary | Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision. Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study is to explore if the developed IM model will help patients with back/neck pain better than usual primary care management, i.e. to test the hypothesis that IM would be more effective than treatment as usual. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Back or Neck Pain of at Least 2 Weeks Duration | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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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 | Active, not recruiting | ||||
| Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | January 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00565942 | ||||
| Other Study ID Numbers ICMJE | IM in Swedish primary care | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Torkel Falkenberg, Karolinska Institutet, Unit for studies of integrative health care | ||||
| Study Sponsor ICMJE | Karolinska Institutet | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Karolinska Institutet | ||||
| Verification Date | November 2007 | ||||
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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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