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. The primary outcome measure will be the change in…
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
Synonym
Health condition
lage rugpijn en nekklachten
Research involving
Sponsors and support
Intervention
Outcome measures
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, numbers of days absent from work
and hospital visits.
Background 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.
Study objective
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.
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.
Study design
A randomized intervention study to assess comparative effectiveness
Intervention
All patients will have the standard care for their specific complaints.
In addition to standard care, the intervention group can be referred by their
GP to a CAM practitioner (Homeopath, Acupuncture, Naturopathy, Osteopathy) or
Tai Chi class. Their GP will actively discuss the possibility to use
complementary therapies and provide the patient with information on the
therapies.
Study burden and risks
All participants will receive standard primary care for their musculoskeletal
pain, thus care as usual.
In addition to standard care, half of the participants can be referred by their
GP to a CAM practitioner (Homeopath, Acupuncture, Naturopathy, Osteopathy) or
Tai Chi class. These additional treatments are currently already used by more
than 70% of patients with musculoskeletal pain, on their own initiative.
However, patients do not disclose the use of CAM therapies to their GP. In the
current study, participants will now discuss CAM use with their GP. We expect
that communication about CAM and possible referall and monitoring of the
outcome of CAM therapies may increase the quality of life of patients by
improvement of symptoms and safer use of CAM therapies in combination with
regular medication.
Furthermore, the selected CAM therapies are reported in literature as safe with
very low risk of adverse events.
We therefore expect that the benefits for the participants will outweigh any
possible burden that they may encounter.
Hoofdstraat 24
Driebergen 3972 LA
NL
Hoofdstraat 24
Driebergen 3972 LA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41527.028.12 |
| OMON | NL-OMON27322 |