Back or Neck Pain of at Least 2 Weeks Duration Clinical Trial
Official title:
Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
| Verified date | October 2020 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | November 2007 |
| Est. primary completion date | November 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing | Huddinge |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Ekhagastiftelsen, HRQL gruppen, Göteborgs universitet, Insamlingsstiftelsen för forskning om manuella terapier, Primary care units at Bagarmossen, Skarpnäck, Dalen and Björkhagen, Svensk förening för vetenskaplig homeopati |
Sweden,
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. — View Citation
Sundberg T, Petzold M, Wändell P, Rydén 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Recruitment of patients | Number of included patients at baseline | At baseline | |
| Other | Retention of patients | Number of patients completing follow-up after 16 weeks | After 16 weeks | |
| Primary | 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 | |
| Primary | Physical functioning | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Role physical | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Bodily pain | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | General health | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Vitality | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Social functioning | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Role emotional | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Mental health | SF-36 domain 0-100 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Disability | Numerical rating scale 0-10 (higher score worse) | Change from baseline to follow-up after 16 weeks | |
| Primary | Stress | Numerical rating scale 0-10 (higher score worse) | Change from baseline to follow-up after 16 weeks | |
| Primary | Well-being | Numerical rating scale 0-10 (higher score better) | Change from baseline to follow-up after 16 weeks | |
| Primary | Use of prescription analgesics | Use of prescription analgesics during the last two weeks (yes/no) | Change from baseline to follow-up after 16 weeks | |
| Primary | 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 | |
| Primary | Use of conventional care | Use of conventional care during the last two weeks (yes/no) | Change from baseline to follow-up after 16 weeks | |
| Primary | Use of complementary care | Use of complementary care during the last two weeks (yes/no) | Change from baseline to follow-up after 16 weeks |