Exploring Integrative Medicine in Swedish Primary Care

NCT00565942 | Completed

• 1 other identifier: IM in Swedish primary care
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Back or Neck Pain of at Least 2 Weeks Duration

Keywords

Integrative medicine; Primary care; Swedish massage therapy; Manual therapy; Naprapathy; Shiatsu; Acupuncture; Qigong; Pragmatic ranomized controlled pilot trial; Health services research

Outcome Measures

Primary Outcomes (16)

• Days with pain

  Number of days with pain over the last two weeks (0-14 days)

  Change from baseline to follow-up after 16 weeks

• Physical functioning

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Role physical

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Bodily pain

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• General health

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Vitality

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Social functioning

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Role emotional

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Mental health

  SF-36 domain 0-100 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Disability

  Numerical rating scale 0-10 (higher score worse)

  Change from baseline to follow-up after 16 weeks

• Stress

  Numerical rating scale 0-10 (higher score worse)

  Change from baseline to follow-up after 16 weeks

• Well-being

  Numerical rating scale 0-10 (higher score better)

  Change from baseline to follow-up after 16 weeks

• Use of prescription analgesics

  Use of prescription analgesics during the last two weeks (yes/no)

  Change from baseline to follow-up after 16 weeks

• Use of non-prescription analgesics

  Use of non-prescription analgesics during the last two weeks (yes/no)

  Change from baseline to follow-up after 16 weeks

• Use of conventional care

  Use of conventional care during the last two weeks (yes/no)

  Change from baseline to follow-up after 16 weeks

• Use of complementary care

  Use of complementary care during the last two weeks (yes/no)

  Change from baseline to follow-up after 16 weeks

Other Outcomes (2)

• Recruitment of patients

  At baseline

• Retention of patients

  After 16 weeks

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Treatment as usual coordinated by general practitioners in primary care.

Procedure: Usual care

Integrative care

ACTIVE COMPARATOR

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

Procedure: Integrative care

Interventions

Integrative care 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.

Integrative care

Usual care 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.

Usual care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Ekhagastiftelsen: collaborator
• Insamlingsstiftelsen för forskning om manuella terapier: collaborator
• Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen: collaborator
• Svensk förening för vetenskaplig homeopati: collaborator
• HRQL gruppen, Göteborgs universitet: collaborator

Study Sites (1)

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

Huddinge, 141 83, Sweden

Location

Related Publications (2)

• 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.

  PMID: 17623105 BACKGROUND

• 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.

  PMID: 19735542 RESULT

Study Officials

• Torkel Falkenberg, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 30, 2007
• Study Start: September 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

SE (1)