To optimize the management of non-chronic shoulder pain in primary care by the introduction of ultrasound as a diagnostic triage tool. The following research questions will be addressed:1. What are the effects of diagnostic ultrasound and its…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures include patient-perceived recovery.
Secondary outcome
The secondary outcome measures include shoulder pain, performance of daily
activities, health-related quality of life, and costs.
Background summary
Shoulder pain presented in primary care results in a poor prognosis,
considerable medical costs, and a prolonged sick leave. The optimal therapy for
shoulder pain in primary care is yet unknown, since clinical history and
physical examination do not provide decisive evidence as to the
patho-anatomical origin of the symptoms. Therefore, for all patients a stepwise
treatment approach is advised. Unfortunately, this approach is expected to
dilute the effects of the interventions in the total population considerably
and delays specific therapy, which is remarkable knowing that a more effective
approach to SP is available. Furthermore, in order to improve treatment
outcome, a correct diagnosis at the earliest possible stage seems necessary. We
hypothesize that this stepwise approach can be improved by giving the general
practitioner (GP) more evidence as to patho-anatomical origin of the symptoms
of SP. The diagnostic shortcoming can be solved by applying ultrasound imaging,
an accurate method in diagnosing shoulder pain. Importantly, there is a clear
relationship between ultrasound diagnosis and the available therapies. However,
the cost-effectiveness of applying ultrasound in the management of shoulder
apin in primary care has not been studied. This study foresees in the evidence
gap that is addressed in the shoulder pain guideline of the Dutch College of
General Practitioners.
Study objective
To optimize the management of non-chronic shoulder pain in primary care by the
introduction of ultrasound as a diagnostic triage tool. The following research
questions will be addressed:
1. What are the effects of diagnostic ultrasound and its related treatment
decisions on clinical recovery and health-related quality of life compared to
the usual primary care?
2. What is the cost-effectiveness of management that includes diagnostic
ultrasound compared to the usual primary care?
3. What is the prevalence of the specific subacromial disorders?
Study design
Randomised (at patient level) controlled trial, with a 52 week follow-up
period.
Intervention
Ultrasound tailored treatment of shoulder pain. The therapeutic strategies
available in the intervention and control group are identical except those used
in the intervention group will be tailored based on the ultrasound results.
Study burden and risks
One week after inclusion patients will receive a telephone call from the
researcher of the dept of General Practice to answer the 1-item questionnaire
regarding the complaints. All patients revisit their GP, but this visit is
foreseen as it is part of usual care.
All randomised patients receive their therapeutic advice during this visit. No
major risks will be associated with tailoring the therapeutic strategies to the
ultrasound results, as these strategies are part of current practice. To
prevent treatment of supposed asymptomatic pathology, ultrasound pathology will
be linked to history and physical examination findings. In case a fracture,
septic bursitis or arthritis, or a life-threatening disorder (e.g. tumour) is
diagnosed, the radiologist will immediately inform the GP with c.c. to the
investigator, and the patient will be excluded. Including baseline, patients
are asked five times to fill in a questionnaire (takes ca. 5 minutes).
Peter Debeyeplein 1
Maastricht 6229 HA
NL
Peter Debeyeplein 1
Maastricht 6229 HA
NL
Listed location countries
Age
Inclusion criteria
* Referral by the GP to the radiology department for ultrasound of the shoulder;
* Shoulder pain upon abduction with painful arc;
* Symptoms lasting no longer than three months;
* First episode of shoulder pain for 12 months;
* Men and women aged between 18 and 65 years.
Exclusion criteria
* Consultation or treatment for SP in the past three months;
* Glenohumeral external rotation range of motion less than 45 degrees;
* History of fractures of the proximal humerus or acromion, dislocation and/or surgery of the affected shoulder;
* Shoulder complaints caused by rheumatic disease, suspected referred complaints or extrinsic cause.
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 | NL31681.068.10 |
OMON | NL-OMON21348 |