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Sponsors and Collaborators: |
Karolinska Institutet Ekhagastiftelsen Insamlingsstiftelsen för forskning om manuella terapier Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen Svensk förening för vetenskaplig homeopati HRQL gruppen, Göteborgs universitet |
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Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00565942 |
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 | Intervention |
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Back or Neck Pain of at Least 2 Weeks Duration |
Procedure: Integrative care Procedure: Usual care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial |
Enrollment: | 80 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
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Usual care: Active Comparator
Treatment as usual coordinated by general practitioners in primary care.
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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.
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Integrative care: Active Comparator
Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
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 |
Responsible Party: | Karolinska Institutet, Unit for studies of integrative health care ( Torkel Falkenberg ) |
Study ID Numbers: | IM in Swedish primary care |
Study First Received: | November 28, 2007 |
Last Updated: | November 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00565942 |
Health Authority: | Sweden: Centrala etikprövningsnämnden |
Integrative medicine Primary care Swedish massage therapy Manual therapy Naprapathy |
Shiatsu Acupuncture/TCM Qigong Pragmatic RCT Health services research |
Signs and Symptoms Neck Pain Neurologic Manifestations Pain |
Nervous System Diseases |