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Completed

NCT Number: NCT00565942

Exploring Integrative Medicine 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 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Department of Neurobiology, Care Sciences and Society, Division of Nursing

Huddinge, 141 83, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrative care

Procedure

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.

usual care

Procedure

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.

Primary outcomes

  1. Days with pain

    Time frame: Change from baseline to follow-up after 16 weeks

    Number of days with pain over the last two weeks (0-14 days)

  2. Physical functioning

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  3. Role physical

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  4. Bodily pain

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  5. General health

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  6. Vitality

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  7. Social functioning

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  8. Role emotional

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  9. Mental health

    Time frame: Change from baseline to follow-up after 16 weeks

    SF-36 domain 0-100 (higher score better)

  10. Disability

    Time frame: Change from baseline to follow-up after 16 weeks

    Numerical rating scale 0-10 (higher score worse)

  11. Stress

    Time frame: Change from baseline to follow-up after 16 weeks

    Numerical rating scale 0-10 (higher score worse)

  12. Well-being

    Time frame: Change from baseline to follow-up after 16 weeks

    Numerical rating scale 0-10 (higher score better)

  13. Use of prescription analgesics

    Time frame: Change from baseline to follow-up after 16 weeks

    Use of prescription analgesics during the last two weeks (yes/no)

  14. Use of non-prescription analgesics

    Time frame: Change from baseline to follow-up after 16 weeks

    Use of non-prescription analgesics during the last two weeks (yes/no)

  15. Use of conventional care

    Time frame: Change from baseline to follow-up after 16 weeks

    Use of conventional care during the last two weeks (yes/no)

  16. Use of complementary care

    Time frame: Change from baseline to follow-up after 16 weeks

    Use of complementary care during the last two weeks (yes/no)

Other outcomes

  1. Recruitment of patients

    Time frame: At baseline

    Number of included patients at baseline

  2. Retention of patients

    Time frame: After 16 weeks

    Number of patients completing follow-up after 16 weeks

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 30, 2007
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.