Back or Neck Pain of at Least 2 Weeks Duration
Conditions
Keywords
Integrative medicine, Primary care, Swedish massage therapy, Manual therapy, Naprapathy, Shiatsu, Acupuncture, Qigong, Pragmatic ranomized controlled pilot trial, Health services research
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.
Interventions
PROCEDUREIntegrative 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.
PROCEDUREUsual 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.
Sponsors
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
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of complementary care | Change from baseline to follow-up after 16 weeks | Use of complementary care 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) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Retention of patients | After 16 weeks | Number of patients completing follow-up after 16 weeks |
| Recruitment of patients | At baseline | Number of included patients at baseline |
Countries
Sweden
Outcome results
None listed