Therefore the aim of the present study is wheter a simultaneus intervention witht (maximal 5) corticosteroïden/lidocaine injections and exercises for the cuff muscles (both according a standard protocol), have better results than a sequential…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the change in pain in rest, during activities or during
the night of the last 24 hours, between baseline and 78 weeks.
Secondary outcome
Change compared to the baselien assessments of:
- DASH questionnaire,
- SF36 questionnaire,
- Analgetica use,
- Participant rated improvement,
- Range of Motion maesurements,
- Painful-Arc,
- complications of injections.
Background summary
In the Netherlands the main part of the patients with shoulder complaints are
treated by their general practitioner.
The NHG-standard of 1999 advises two-weakly injections with
triamcinolonacetonide subacromial or intra-articulair, dependent of the
physical examination of the patient. So far only short-term efficacy of
injections with triamcinolonacetonide has been proven by clinical studies.
However, so far the long-term efficacy remains unknown. A possible explanation
could be that in these studies the treatment period was shorter than 6 weeks,
and the protocol never exceeded more than three injection.
Study objective
Therefore the aim of the present study is wheter a simultaneus intervention
witht (maximal 5) corticosteroïden/lidocaine injections and exercises for the
cuff muscles (both according a standard protocol), have better results than a
sequential intervention of first (maximal 3) corticosteroïden/lidocaine
injections followed after 6 weeks by exercises (usual care, according to NHG
standard) in a group of patients with shoulder complaints.
Study design
In total 205 patients will be recruited of a GPs population of 20,000 patients.
Patients will be concealed randomized into 2 groups, group A a simultaneus
intervention in which the patients will be injected with a combination of
lidocaine and 1 ml Kenacort A40 and at the same time exercises; and group B in
which the patient will be injected with a combination of lidocaine and 1 ml
Kenacort A40 and after six weeks according to the NHG-standard with exercises.
Intervention
group A a simultaneus intervention in which the patients will be injected with
a combination of lidocaine and 1 ml Kenacort A40 and at the same time
exercises; and group B in which the patient will be injected with a
combination of lidocaine and 1 ml Kenacort A40 and after six weeks according to
the NHG-standard with exercises.
Study burden and risks
none
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Those patients with shoulder complaints consulting ther GP with complaints also during the night, and presence of painfull-arc and restricted range of motion.
Exclusion criteria
not signed informed consent form, age under 18 or above 70 year, treatment (exercises or corticosteroid injections) of shoulder complaints during the last 6 months, insufficient command of the Dutch language, spoken and/or written.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12459.078.06 |