Adhesive Capsulitis
Conditions
Brief summary
This study aims, by means of a randomized control trial, to investigate which treatment method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises) gives better results on clinically relevant outcomes (range of glenohumeral motion, psychological factors, pain, shoulder function, quality of life) and on parameters derived from arthroscopic glenohumeral investigation by means of MRI. Furthermore, associations between (1) the results on the MRI investigation, (2) the range of glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be assessed at different time-points (before and at 6-12-18 and 52 weeks after the first injection).
Interventions
OTHERPhysical therapy focus on manual therapy and home-exercises
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
OTHERPhysical therapy focus on education and supported home exercises
corticosteroid injection + physiotherapy with focus on education and supported home exercises
Sponsors
Jessa Hospital
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 50 % loss of passive GH external rotation motion, together with motion losses greater than 25% in at least two other GH movements, as compared to the unaffected side * the pain accompanying the motion losses has to be present for at least one month. During that month, the pain and mobility deficits have to be stable or get worse
Exclusion criteria
* bilateral frozen shoulder * systemic and/or neurologic disease or a self-reported pathologic condition of the cervical/thoracic region, elbow or wrist/hand
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief pain inventory | baseline | assessment of current, worst and night pain on a 11 point likert scale |
| Scapulothoracic, glenohumeral and elbow joint range of motion | baseline | before the first injection with corticosteroids By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance |
| parameters on arthrographic investigation by means of MRI | baseline | the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated. |
| Disability of the shoulder, elbow and hand questionnaire | baseline | assessment of upper limb function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L questionnaire | baseline | Quality of life assessment |
| Self-efficacy questionnaire | baseline | this questionnaire assesses the self-efficacy of a person |
| Tampa scale of kinesiophobia | baseline | this scale investigates fear of movement |
| Hospital anxiety and depression scale | baseline | this scale investigates anxiety and depression |
Countries
Belgium
Contacts
Primary ContactLiesbet De Baets, dr.
Backup ContactAnnick Timmermans, prof. dr.
Outcome results
None listed