Clinical trial NCT00565942: Exploring Integrative Medicine in Swedish Primary Care
Official title: Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ekhagastiftelsen
name: Insamlingsstiftelsen för forskning om manuella terapier
name: Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen
name: Svensk förening för vetenskaplig homeopati
name: HRQL gruppen, Göteborgs universitet
First posted: 2007-11-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Days with pain
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Physical functioning
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Role physical
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Bodily pain
timeFrame: Change from baseline to follow-up after 16 weeks
measure: General health
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Vitality
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Social functioning
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Role emotional
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Mental health
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Disability
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Stress
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Well-being
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Use of prescription analgesics
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Use of non-prescription analgesics
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Use of conventional care
timeFrame: Change from baseline to follow-up after 16 weeks
measure: Use of complementary care
timeFrame: Change from baseline to follow-up after 16 weeks
Secondary outcomes:
Other outcomes:
measure: Recruitment of patients
timeFrame: At baseline
measure: Retention of patients
timeFrame: After 16 weeks
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
Study officials:
affiliation: Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
name: Torkel Falkenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.