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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
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.
Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing
Huddinge, Sweden
Days with pain
Number of days with pain over the last two weeks (0-14 days)
Time frame: Change from baseline to follow-up after 16 weeks
Physical functioning
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Role physical
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Bodily pain
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
General health
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Vitality
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Social functioning
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Role emotional
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Mental health
SF-36 domain 0-100 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Disability
Numerical rating scale 0-10 (higher score worse)
Time frame: Change from baseline to follow-up after 16 weeks
Stress
Numerical rating scale 0-10 (higher score worse)
Time frame: Change from baseline to follow-up after 16 weeks
Well-being
Numerical rating scale 0-10 (higher score better)
Time frame: Change from baseline to follow-up after 16 weeks
Use of prescription analgesics
Use of prescription analgesics during the last two weeks (yes/no)
Time frame: 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)
Time frame: Change from baseline to follow-up after 16 weeks
Use of conventional care
Use of conventional care during the last two weeks (yes/no)
Time frame: Change from baseline to follow-up after 16 weeks
Use of complementary care
Use of complementary care during the last two weeks (yes/no)
Time frame: Change from baseline to follow-up after 16 weeks
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