We will evaluate the clinical and cost-effectiveness of the two guideline recommended treatments for patients with persisting shoulder pain over a 12 month time period. Patients will be randomized to a local corticosteroid injection or referral for…
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Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures will be pain and function (captured together in
SPADI total score) over 12 months.
Secondary outcome
The secondary outcome measure will be incremental cost per quality adjusted
life year (QALY) gained, using both the medical as well as the societal
perspective, over 12 months post-randomisation. Medical costs will be measured
using the Medical Cost Questionnaire (MCQ) and societal costs will be measured
using the Productivity Cost Questionnaire (PCQ). QALY will be measured using
the five-level version of the well-validated EuroQol Five-Dimensional
Questionnaire (EQ-5D-5L) score.
Furthermore, secondary outcome measures will include short and long-term (6
weeks, 3,6,9, en 12 months) assessment of global perceived effect, quality of
life, side effects, sleep quality, work absence, and healthcare utilisation. In
addition, side effects and any serious adverse events (SAE) will be assessed.
Background summary
In the Netherlands, the annual prevalence of shoulder pain in primary care is
estimated at 42 per 1000 person-years, which means that a general practitioner
(GP) on average is consulted by a patient with shoulder pain twice a week.
After 6 months, only 50% of shoulder pain patients that have visited their GP
report to be recovered and after 1 year 40% of patients still report shoulder
pain.
More than half of the patients (55%) with persistent shoulder pain revisit
their GP for additional treatment (2.1 +/- 1.3 additional consultations while
receiving 'usual care'). Treatment of shoulder pain and related work absence
generate high costs to healthcare and society. A recent cost-estimation study
for patients with shoulder pain consulting primary care in Sweden (comparable
health system to the Netherlands) showed that the mean annual total costs were
¤4.139,-- per patient with sick leave accounting for more than 80% of the total
costs for society.
Study objective
We will evaluate the clinical and cost-effectiveness of the two guideline
recommended treatments for patients with persisting shoulder pain over a 12
month time period. Patients will be randomized to a local corticosteroid
injection or referral for physiotherapist-led exercise therapy.
Study design
The study is a randomised, multicentre, open label, parallel group, pragmatic
clinical trial. With a cohort substudy including patient who did not want to
participate in the trial or patients that were not (yet) eligible for
participation in the trial.
Intervention
Patients in the RCT will be randomized to either a local corticosteroid
injection or referral for physiotherapist-led exercise therapy
Patients randomized to the corticosteroid injection, will get an CI as
recommended in the NHG guideline, the location of the injection is determined
by the type of shoulder complaint as assessed during physical examination by
the GP. Number of injections and injection locations will be recorded by the
GP throughout the follow-up period.
Patients randomized to physiotherapist-led exercise therapy will be referred to
one of the local phsyiotherapists.
Study burden and risks
This is a (cost-)efficiency study on the regular care for shoulder pain in the
general practice, according to the recommended management by the NHG-guideline
'Shoulder complaints' Both treatment options, injection and exercise-therapy,
which the patient participating in this trial will be randomized are
recommended by the NHG guideline. The burden for the patient is in the
questionnaires, which are used to extract the outcomes of this study: pain,
function and costs.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet all
of the following criteria:
1) contacted their GP due to a new episode of shoulder pain (ICPC L92 or L08
with unequivocal diagnosis of shoulder complaints)
2) aged 18 years and over
3) has an indication for corticosteroid injection or physiotherapist-led
exercise therapy as recommended by the guideline for shoulder complaints by the
NHG
4) signed informed consent form.
Exclusion criteria
1) They are outside the scope of the NHG guideline (eg, shoulder complaints due
to recent serious trauma, malignity*s, systemic diseases, neurological or
cardial diseases)
2) There is a history of significant shoulder trauma (eg, dislocation, fracture
or full thickness tear requiring surgery)
3) They have received a corticosteroid injection or physiotherapy for shoulder
complaints in the last 6 months
4) local or systemic infection, after recent vaccination with live attenuated
vaccine
5) coagulopathy, use of anticoagulants
6) A history of gastric ulcer
7) Use of CYP3A-inductors
8) Pregnancy
9) Use of oral corticosteroids
10) Allergy to corticosteroids or to anesthetics of the amide type or to the
respective preservative (methyl or propyl parahydroxybenzoate or their
metabolite para-aminobenzoic acid) or to sulfite;
11) Unable to complete questionnaires in Dutch
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2020-000662-42-NL |
| CCMO | NL71774.078.20 |