Exploring Integrative Medicine in Swedish Primary Care

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT00565942

Collaborator

Ekhagastiftelsen (Other), Insamlingsstiftelsen för forskning om manuella terapier (Other), Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen (Other), Svensk förening för vetenskaplig homeopati (Other), HRQL gruppen, Göteborgs universitet (Other)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Back or Neck Pain of at Least 2 Weeks Duration	Procedure: Integrative care Procedure: Usual care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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)
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)
Stress [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 non-prescription analgesics [Change from baseline to follow-up after 16 weeks]
Use of non-prescription analgesics during the last two weeks (yes/no)
Use of conventional care [Change from baseline to follow-up after 16 weeks]
Use of conventional care 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)

Other Outcome Measures

Recruitment of patients [At baseline]
Number of included patients at baseline
Retention of patients [After 16 weeks]
Number of patients completing follow-up after 16 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.