Exploring Integrative Medicine in Swedish Primary Care
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|ClinicalTrials.gov Identifier: NCT00565942|
Recruitment Status : Unknown
Verified November 2007 by Karolinska Institutet.
Recruitment status was: Active, not recruiting
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Back or Neck Pain of at Least 2 Weeks Duration||Procedure: Integrative care Procedure: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial|
|Study Start Date :||September 2004|
|Estimated Study Completion Date :||January 2008|
Active Comparator: Usual care
Treatment as usual coordinated by general practitioners in primary care.
Procedure: Usual care
The usual care treatment was coordinated by the patient's general practitioner and complied with the clinical practice routines at the participating primary care units. Conventional procedures included but were not exclusive to advice, prescription of drugs, sick leave and physiotherapy/physical therapy. There were no constraints to the provided usual care as the study aimed to pragmatically reflect the general practitioners' standard care and treatment as usual.
Active Comparator: Integrative care
Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.
Procedure: Integrative care
In short, integrative care was up to 10 complementary therapy treatments delivered to the patient in addition to the usual care over an intervention period of up to 12 weeks. The integrative care was provided by a multidisciplinary team coordinated by a gate keeping general practitioner with clinical knowledge and experience of CTs and senior licensed/certified CT providers representing Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong.
- Pain, disability, stress, wellbeing, use of analgesics and health care [ Time Frame: At 12 weeks, 16 weeks and after 18 months ]
- Health related quality of life [ Time Frame: At 12 weeks, 16 weeks and after 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565942
|Karolinska Institutet, Unit for studies of integrative health care|
|Huddinge, Sweden, 141 83|
|Principal Investigator:||Torkel Falkenberg, PhD||Karolinska Institutet, Unit for studies of integrative health care|