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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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Back or Neck Pain of at Least 2 Weeks Duration Procedure: Integrative care Procedure: Usual care

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Pain, disability, stress, wellbeing, use of analgesics and health care [ Time Frame: At 12 weeks, 16 weeks and after 18 months ]

Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: At 12 weeks, 16 weeks and after 18 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Back/neck pain with or without headache for at least two weeks and at least three times per week
  • Resident of Stockholm County
  • Literate in Swedish
  • Willing and able to comply with study requirements

Exclusion Criteria:

  • Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.
Contacts and Locations

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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
Sponsors and Collaborators
Karolinska Institutet
Insamlingsstiftelsen för forskning om manuella terapier
Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen
Svensk förening för vetenskaplig homeopati
HRQL gruppen, Göteborgs universitet
Principal Investigator: Torkel Falkenberg, PhD Karolinska Institutet, Unit for studies of integrative health care
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Torkel Falkenberg, Karolinska Institutet, Unit for studies of integrative health care
ClinicalTrials.gov Identifier: NCT00565942     History of Changes
Other Study ID Numbers: IM in Swedish primary care
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007

Keywords provided by Karolinska Institutet:
Integrative medicine
Primary care
Swedish massage therapy
Manual therapy
Pragmatic RCT
Health services research

Additional relevant MeSH terms:
Neck Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms