|- candidate number||15070|
|- NTR Number||NTR4059|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jul-2013|
|- Secondary IDs||NL41527.028.12 METC |
|- Public Title||Proeftuin Integrative Medicine
|- Scientific Title||Prospective Study to Assess the Effectiveness of an Integrative Primary Care Approach versus Standard Primary Care Management of
Chronic Musculoskeletal Pain
|- hypothesis||An integrative primary care approach, including communicating about and referring to CAM, may enhance quality of life of chronically ill patients
|- Healt Condition(s) or Problem(s) studied||Osteoarthritis, Rheumatoid arthritis, Fibromyalgia, Low back pain (LBP), Neck pain, Arthrosis, Tennis elbow|
|- Inclusion criteria||• Patients visiting a GP|
• With chronic musculoskeletal pain for a duration of ≥ 3 months due to: (Osteo)arthritis, rheumatoid arthritis, fibromyalgia, low back pain, neck pain, tennis elbow or golfers arm, non-specific joint complaints,
• Written informed consent
• >18 years
• Ability to understand and speak the Dutch language
• Accessible by phone and internet.
|- Exclusion criteria||• Patients with malignant diseases |
• Patients with vertebral fractures
• Patients with severe of progressive neurological symptoms
• Patients with psychiatric complaints
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2013|
|- planned closingdate||31-dec-2015|
|- Target number of participants||268|
|- Interventions||Standard Primary Care Management (SPC): SPC will be according to the NHG guidelines and depends on the diagnosis and severity of complaints. SPC can include: Rest, physical exercise, physiotherapy, behavioural therapy and pharmacological treatment such as NSAID’s, systemic corticosteroids, DMARD’s such as methotrexaat, cyclosporine, hydroxychloroquine, sulfasalazine and azathioprine. |
Integrative Primary Care Approach (IPC): In IPC, GPs can refer patients to five CAM therapies: Acupuncture, Tai-Chi, Osteopathy, Homeopathy and Naturopathy. Referral to a CAM therapy is in addition to SPC. The GP and the patient together will make the selection which CAM therapy is most suitable for the patient and his/her specific complaints.
|- Primary outcome||Quality of life: will be measured using a 36-item health survey (SF-36).
|- Secondary outcome||• Patient-rated pain: Patients are asked to rate their typical musculoskeletal pain on an ordinal 11-box scale rating (PRP) from no pain (0) to worst pain possible (10).|
• Fatigue: Mean fatigue symptoms will be measured using the 20-item Multidimensional Fatigue Inventory (MFI), including questions on physical and mental fatigue.
• Self efficacy is measured by the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item scale used to assess the level of self-confidence in performing functional and social activities despite the presence of pain.
• Self-reported changes in main concern and well being by the Measure Yourself Concerns and Well-being (MYCaW).
• Changes in use of (pain) medication for musculoskeletal pain.
• Sense of Coherence: will be measured using the 29-item Dutch Sense of Coherence questionnaire (SOC).
• Patients’ satisfaction with treatment and health care provider using the Participants’ Satisfaction questionnaire (PS).
• Patients’ Expectations about the treatment they will receive will be documented by short questionnaires (PE).
• GPs’ opinion on SPC and IPC of chronic musculoskeletal pain, using a GP questionnaire (GPQ).
• Disease Related Costs: Data with respect to direct healthcare costs, direct non-healthcare costs and indirect costs will be collected in a questionnaire (DRC), including questions on medication use, use of complementary therapies, numbers of days absent from work and hospital visits.
|- Timepoints||Individual duration: |
12 months in total under the study
• T=0: Inclusion, baseline measurements
• T=3: Three months observation
• T=6: Six months observation
• T=12: Twelve months observation, study end point
Total duration of the study:
2,5 year: One year for inclusion of all patients, one year follow/up and half a year for including data analysis and reporting.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Jong|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Jong|
|- Sponsor/Initiator ||Louis Bolk Institute|
(Source(s) of Monetary or Material Support)
|PGO fund of the Dutch Ministry of Health, Welfare and Sports.|
|- Brief summary||The use of Complementary and Alternative Medicine (CAM) among patients with chronic musculoskeletal pain has become increasingly popular in different countries. During the past two years in the Netherlands, 71% of the patients with chronic musculoskeletal pain visited a CAM practitioner. Manual therapists, acupuncturists and homeopaths were most frequently visited. CAM practitioners work mostly outside the world of conventional medicine. The majority of patients do not disclose these CAM visits to their General Physician (GP). However, previous studies have shown that the majority of patients would like to discuss CAM use and prefer a GP that refers them to CAM. To meet needs of patients, primary care disease management may thus benefit from an active involvement of GPs concerning CAM communication/referral. In the current study we would like to investigate the outcome of such an integrative primary care approach, in which the GP can refer patients to additional CAM therapies. The goal of this prospective study is to compare the outcome of an integrative primary care (IPC) approach with standard primary care (SPC) management of patients with chronic musculoskeletal pain. A randomized intervention study is conducted to assess comparative effectiveness among patients of 18 year and older with chronic musculoskeletal pain for the duration of > 3 months who are visiting a GP. The primary outcome measure will be the change in quality of life. In addition, we anticipate to gain more insights in other factors related to chronic musculoskeletal pain such as pain, fatigue and general well-being.
|- Main changes (audit trail)|
|- RECORD||3-jul-2013 - 21-jul-2013|