Exploring Integrative Medicine in Swedish Primary Care

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

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.

Study Overview

• Status: Completed
• Conditions: Back or Neck Pain of at Least 2 Weeks Duration
• Intervention / Treatment: Procedure: Usual care; Procedure: Integrative care

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 141 83
    • Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Usual care; Treatment as usual coordinated by general practitioners in primary care.	Procedure: Usual care; 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.
ACTIVE_COMPARATOR: Integrative care; Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.	Procedure: Integrative care; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of patients	Number of included patients at baseline	At baseline
Retention of patients	Number of patients completing follow-up after 16 weeks	After 16 weeks

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Torkel Falkenberg, PhD, Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: November 28, 2007
• First Submitted That Met QC Criteria: November 28, 2007
• First Posted (ESTIMATE): November 30, 2007

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Acupuncture; Primary care; Integrative medicine; Health services research; Manual therapy; Qigong; Shiatsu; Naprapathy; Swedish massage therapy; Pragmatic ranomized controlled pilot trial
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: IM in Swedish primary care