This trial is active, not recruiting.

Condition back or neck pain of at least 2 weeks duration
Treatments integrative care, usual care
Sponsor Karolinska Institutet
Collaborator Ekhagastiftelsen
Start date September 2004
End date January 2008
Trial size 80 participants
Trial identifier NCT00565942, IM in Swedish primary care


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 is to explore if the developed IM model will help patients with back/neck pain better than usual primary care management, i.e. to test the hypothesis that IM would be more effective than treatment as usual.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Treatment as usual coordinated by general practitioners in primary care.
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)
Selected complementary therapies (Swedish massage therapy, manual therapy/naprapathy, shiatsu, acupuncture and qigong) added to usual care.
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.

Primary Outcomes

Pain, disability, stress, wellbeing, use of analgesics and health care
time frame: At 12 weeks, 16 weeks and after 18 months

Secondary Outcomes

Health related quality of life
time frame: At 12 weeks, 16 weeks and after 18 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Principal investigator Torkel Falkenberg, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by Karolinska Institutet.