Exploring Integrative Medicine in Swedish Primary Care

NCT ID: NCT00565942

Last Updated: 2020-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-11-30

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 was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.

Detailed Description

Study objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.

Conditions

Back or Neck Pain of at Least 2 Weeks Duration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care

Treatment as usual coordinated by general practitioners in primary care.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: PROCEDURE

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.

Integrative care

Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.

Group Type: ACTIVE_COMPARATOR

Integrative care

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ekhagastiftelsen

OTHER

Sponsor Role: collaborator

Insamlingsstiftelsen för forskning om manuella terapier

UNKNOWN

Sponsor Role: collaborator

Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen

UNKNOWN

Sponsor Role: collaborator

Svensk förening för vetenskaplig homeopati

UNKNOWN

Sponsor Role: collaborator

HRQL gruppen, Göteborgs universitet

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Torkel Falkenberg

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torkel Falkenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing

Locations

Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing

Huddinge, , Sweden

Countries

Sweden

References

Sundberg T, Halpin J, Warenmark A, Falkenberg T. Towards a model for integrative medicine in Swedish primary care. BMC Health Serv Res. 2007 Jul 10;7:107. doi: 10.1186/1472-6963-7-107.

Reference Type: BACKGROUND

PMID: 17623105 (View on PubMed)

Sundberg T, Petzold M, Wandell P, Ryden A, Falkenberg T. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial. BMC Complement Altern Med. 2009 Sep 7;9:33. doi: 10.1186/1472-6882-9-33.

Reference Type: RESULT

PMID: 19735542 (View on PubMed)

Other Identifiers

IM in Swedish primary care

Identifier Type: -

Identifier Source: org_study_id