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Exploring Integrative Medicine in Swedish Primary Care

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Karolinska Institute

Status

Completed

Conditions

Back or Neck Pain of at Least 2 Weeks Duration

Treatments

Procedure: Usual care
Procedure: Integrative care

Study type

Interventional

Funder types

Other

Identifiers

NCT00565942
IM in Swedish primary care

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Usual care
Active Comparator group
Description:
Treatment as usual coordinated by general practitioners in primary care.
Treatment:
Procedure: Usual care
Integrative care
Active Comparator group
Description:
Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.
Treatment:
Procedure: Integrative care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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