To evaluate the difference in functional outcome, measured by the SPADI, after treatment of adhesive capsulitis with or without physiotherapy
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Function, measured by the SPADI
Secondary outcome
Pain (Numeric pain rating scale)
General health (RAND 36 = dutch validated SF 36)
Range of motion
patient perceived satisfaction (PPSI)
Background summary
Adhesive capsulitis (frozen shoulder) is a common cause of shoulder pain and
affects approximately 2% of the general population. Corticosteroid injections
and physiotherapy are among the most widely used treatment modalities in
adhesive capsulitis, in both primary and secondary healthcare settings.
according to the current literature, it is uncertain whether physiotherapy is
of clinical relevant additional value above a corticosteroid injection alone.
Study objective
To evaluate the difference in functional outcome, measured by the SPADI, after
treatment of adhesive capsulitis with or without physiotherapy
Study design
(multicenter) Prospective randomised trial
Study burden and risks
Subjective scores to fill out, and an increased number of (non-invasive)
measurements of the function of the shoulder. Follow up consists of three
moments at 6 weeks, 3 months and 6 months. The physiotherapy program does not
differ much of the current regular treatment. The patients who recieve
physiotherapy can expercience pain due to the physiotherapy program. The
intensity of the program can be decreased. The benefit of the study is to
provide an answer to the question if we have to treat a patient with a frozen
shoulder with a physiotherapy program after a corticosteroid injection. If not,
this can save a lot of time, effort and money of the patients and the
healthcare system.
Louwesweg 6
AMSTERDAM 1066 EC
NL
Louwesweg 6
AMSTERDAM 1066 EC
NL
Listed location countries
Age
Inclusion criteria
• Age >= 25 years
• Clinical signs of frozen shoulder being:
Symptoms of pain and stiffness, predominantly in one shoulder, persisting >= 3 months, without preliminary trauma.
Restriction of passive motion in the glenohumeral joint with scapular stabilisation of >=30° in >=2 planes of movement, measured to onset of pain.
• Unsuccessful conservative therapy within the previous 3 months
Exclusion criteria
• Previous corticosteroid injection in the shoulder region within 6 weeks
• Evidence of a complete rotator cuff tear on physical examination, ultrasound images or MRI
• Acute subacromial/subdeltoid bursitis
• Osteoarthritis of the glenohumeral or acromioclavicular joint, Kellgren-Lawrence osteoarthritis grading scale >= 2
Anticoagulation in therapeutic range (INR >1,7)
• Previous surgery to the shoulder
• Systemic inflammatory joint disease
• Neurological disorders upper limb
• Other known shoulder pathology as infection or tumor
• Contra-indication to corticosteroid injection, allergy to contrast or local anaesthetic
• Inability to give informed consent and fill out questionnaires
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 | NL47325.048.13 |