Exploring Integrative Medicine in Swedish Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial

Conditions
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Back or Neck Pain of at Least 2 Weeks Duration

Intervention / Treatment
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* Procedure: Integrative care
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Treatment as usual coordinated by general practitioners in primary care. | Procedure: Usual care<br>* 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.<br>|
| Active Comparator: Integrative care<br>Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care. | Procedure: Integrative care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrative medicine, Primary care, Swedish massage therapy, Manual therapy, Naprapathy, Shiatsu, Acupuncture, Qigong, Pragmatic ranomized controlled pilot trial, Health services research