Exploring Integrative Medicine in Swedish Primary Care
- Conditions
- Back or Neck Pain of at Least 2 Weeks Duration
- Interventions
- Procedure: Usual careProcedure: Integrative care
- Registration Number
- NCT00565942
- Lead Sponsor
- Karolinska Institutet
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care Treatment as usual coordinated by general practitioners in primary care. Integrative care Integrative care Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.
- Primary Outcome Measures
Name Time Method Use of conventional care Change from baseline to follow-up after 16 weeks Use of conventional care during the last two weeks (yes/no)
Days with pain Change from baseline to follow-up after 16 weeks Number of days with pain over the last two weeks (0-14 days)
Physical functioning Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Role physical Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Bodily pain Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Stress Change from baseline to follow-up after 16 weeks Numerical rating scale 0-10 (higher score worse)
Use of non-prescription analgesics Change from baseline to follow-up after 16 weeks Use of non-prescription analgesics during the last two weeks (yes/no)
General health Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Vitality Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Social functioning Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Role emotional Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Mental health Change from baseline to follow-up after 16 weeks SF-36 domain 0-100 (higher score better)
Disability Change from baseline to follow-up after 16 weeks Numerical rating scale 0-10 (higher score worse)
Well-being Change from baseline to follow-up after 16 weeks Numerical rating scale 0-10 (higher score better)
Use of prescription analgesics Change from baseline to follow-up after 16 weeks Use of prescription analgesics during the last two weeks (yes/no)
Use of complementary care Change from baseline to follow-up after 16 weeks Use of complementary care during the last two weeks (yes/no)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
🇸🇪Huddinge, Sweden