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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manual therapy and home-exercises | Active Comparator | corticoid injection + physiotherapy with a focus on manual therapy and home-exercises |
|
| education and supported home exercises | Active Comparator | corticosteroid injection + physiotherapy with focus on education and supported home exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapy focus on manual therapy and home-exercises | Other | corticoid injection + physiotherapy with a focus on manual therapy and home-exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scapulothoracic, glenohumeral and elbow joint range of motion | 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 | baseline |
| Scapulothoracic, glenohumeral and elbow joint range of motion | after 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 | week 6 |
| Scapulothoracic, glenohumeral and elbow joint range of motion | after 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 | week 12 |
| Scapulothoracic, glenohumeral and elbow joint range of motion | after 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 | week 18 |
| Scapulothoracic, glenohumeral and elbow joint range of motion | after 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 | week 52 |
| parameters on arthrographic investigation by means of MRI | the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated. |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-5L questionnaire | Quality of life assessment | baseline |
| EQ-5D-5L questionnaire | Quality of life assessment | week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liesbet De Baets, dr. | Contact | +32 11 29 21 29 | liesbet.debaets@uhasselt.be | |
| Annick Timmermans, prof. dr. | Contact | annick.timmermans@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Liesbet De Baets, dr. | Hasselt University | Study Chair |
| Annick Timmermans, prof. dr. | Hasselt University | Principal Investigator |
| Carl Dierickx, prof. dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises
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| Physical therapy focus on education and supported home exercises | Other | corticosteroid injection + physiotherapy with focus on education and supported home exercises |
|
| baseline |
| parameters on arthrographic investigation by means of MRI | the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated. | week 18 |
| Disability of the shoulder, elbow and hand questionnaire | assessment of upper limb function | baseline |
| Disability of the shoulder, elbow and hand questionnaire | assessment of upper limb function | week 6 |
| Disability of the shoulder, elbow and hand questionnaire | assessment of upper limb function | week 12 |
| Disability of the shoulder, elbow and hand questionnaire | assessment of upper limb function | week 18 |
| Disability of the shoulder, elbow and hand questionnaire | assessment of upper limb function | week 52 |
| Brief pain inventory | assessment of current, worst and night pain on a 11 point likert scale | baseline |
| Brief pain inventory | assessment of current, worst and night pain on a 11 point likert scale | week 6 |
| Brief pain inventory | assessment of current, worst and night pain on a 11 point likert scale | week 12 |
| Brief pain inventory | assessment of current, worst and night pain on a 11 point likert scale | week 18 |
| Brief pain inventory | assessment of current, worst and night pain on a 11 point likert scale | week 52 |
| EQ-5D-5L questionnaire | Quality of life assessment | week 12 |
| EQ-5D-5L questionnaire | Quality of life assessment | week 18 |
| EQ-5D-5L questionnaire | Quality of life assessment | week 52 |
| Self-efficacy questionnaire | this questionnaire assesses the self-efficacy of a person | baseline |
| Self-efficacy questionnaire | this questionnaire assesses the self-efficacy of a person | week 6 |
| Self-efficacy questionnaire | this questionnaire assesses the self-efficacy of a person | week 12 |
| Self-efficacy questionnaire | this questionnaire assesses the self-efficacy of a person | week 18 |
| Self-efficacy questionnaire | this questionnaire assesses the self-efficacy of a person | week 52 |
| Tampa scale of kinesiophobia | this scale investigates fear of movement | baseline |
| Tampa scale of kinesiophobia | this scale investigates fear of movement | week 6 |
| Tampa scale of kinesiophobia | this scale investigates fear of movement | week 12 |
| Tampa scale of kinesiophobia | this scale investigates fear of movement | week 18 |
| Tampa scale of kinesiophobia | this scale investigates fear of movement | week 52 |
| Hospital anxiety and depression scale | this scale investigates anxiety and depression | baseline |
| Hospital anxiety and depression scale | this scale investigates anxiety and depression | week 6 |
| Hospital anxiety and depression scale | this scale investigates anxiety and depression | week 12 |
| Hospital anxiety and depression scale | this scale investigates anxiety and depression | week 18 |
| Hospital anxiety and depression scale | this scale investigates anxiety and depression | week 52 |
| Jessa ziekenhuis, Universiteit Hasselt |
| Study Chair |