Exploring Integrative Medicine in Swedish Primary Care
Primary Purpose
Back or Neck Pain of at Least 2 Weeks Duration
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Integrative care
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Back or Neck Pain of at Least 2 Weeks Duration focused on measuring Integrative medicine, Primary care, Swedish massage therapy, Manual therapy, Naprapathy, Shiatsu, Acupuncture, Qigong, Pragmatic ranomized controlled pilot trial, Health services research
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.
Sites / Locations
- Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual care
Integrative care
Arm Description
Treatment as usual coordinated by general practitioners in primary care.
Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.
Outcomes
Primary Outcome Measures
Days with pain
Number of days with pain over the last two weeks (0-14 days)
Physical functioning
SF-36 domain 0-100 (higher score better)
Role physical
SF-36 domain 0-100 (higher score better)
Bodily pain
SF-36 domain 0-100 (higher score better)
General health
SF-36 domain 0-100 (higher score better)
Vitality
SF-36 domain 0-100 (higher score better)
Social functioning
SF-36 domain 0-100 (higher score better)
Role emotional
SF-36 domain 0-100 (higher score better)
Mental health
SF-36 domain 0-100 (higher score better)
Disability
Numerical rating scale 0-10 (higher score worse)
Stress
Numerical rating scale 0-10 (higher score worse)
Well-being
Numerical rating scale 0-10 (higher score better)
Use of prescription analgesics
Use of prescription analgesics during the last two weeks (yes/no)
Use of non-prescription analgesics
Use of non-prescription analgesics during the last two weeks (yes/no)
Use of conventional care
Use of conventional care during the last two weeks (yes/no)
Use of complementary care
Use of complementary care during the last two weeks (yes/no)
Secondary Outcome Measures
Full Information
NCT ID
NCT00565942
First Posted
November 28, 2007
Last Updated
October 27, 2020
Sponsor
Karolinska Institutet
Collaborators
Ekhagastiftelsen, Insamlingsstiftelsen för forskning om manuella terapier, Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen, Svensk förening för vetenskaplig homeopati, HRQL gruppen, Göteborgs universitet
1. Study Identification
Unique Protocol Identification Number
NCT00565942
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Ekhagastiftelsen, Insamlingsstiftelsen för forskning om manuella terapier, Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen, Svensk förening för vetenskaplig homeopati, HRQL gruppen, Göteborgs universitet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Treatment as usual coordinated by general practitioners in primary care.
Arm Title
Integrative care
Arm Type
Active Comparator
Arm Description
Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.
Intervention Type
Procedure
Intervention Name(s)
Integrative care
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days with pain
Description
Number of days with pain over the last two weeks (0-14 days)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Physical functioning
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Role physical
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Bodily pain
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
General health
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Vitality
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Social functioning
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Role emotional
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Mental health
Description
SF-36 domain 0-100 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Disability
Description
Numerical rating scale 0-10 (higher score worse)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Stress
Description
Numerical rating scale 0-10 (higher score worse)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Well-being
Description
Numerical rating scale 0-10 (higher score better)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Use of prescription analgesics
Description
Use of prescription analgesics during the last two weeks (yes/no)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Use of non-prescription analgesics
Description
Use of non-prescription analgesics during the last two weeks (yes/no)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Use of conventional care
Description
Use of conventional care during the last two weeks (yes/no)
Time Frame
Change from baseline to follow-up after 16 weeks
Title
Use of complementary care
Description
Use of complementary care during the last two weeks (yes/no)
Time Frame
Change from baseline to follow-up after 16 weeks
Other Pre-specified Outcome Measures:
Title
Recruitment of patients
Description
Number of included patients at baseline
Time Frame
At baseline
Title
Retention of patients
Description
Number of patients completing follow-up after 16 weeks
Time Frame
After 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torkel Falkenberg, PhD
Organizational Affiliation
Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
City
Huddinge
ZIP/Postal Code
141 83
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
17623105
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.
Results Reference
background
PubMed Identifier
19735542
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.
Results Reference
result
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Exploring Integrative Medicine in Swedish Primary Care
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