Education-based Physical Therapy Approach for Adhesive Capsulitis

Study Overview
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Brief Summary
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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).

Official Title
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Physiotherapy in Adhesive Capsulitis Pathology: Effect of an Education Based Approach on Arthroscopic Evaluation Results, Joint Range of Motion, Psychosocial Factors, Shoulder Pain and Arm Function

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Other: Physical therapy focus on manual therapy and home-exercises
* Other: Physical therapy focus on education and supported home exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: manual therapy and home-exercises<br>corticoid injection + physiotherapy with a focus on manual therapy and home-exercises | Other: Physical therapy focus on manual therapy and home-exercises<br>* corticoid injection + physiotherapy with a focus on manual therapy and home-exercises<br>|
| Active Comparator: education and supported home exercises<br>corticosteroid injection + physiotherapy with focus on education and supported home exercises | Other: Physical therapy focus on education and supported home exercises<br>* corticosteroid injection + physiotherapy with focus on education and supported home exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L questionnaire | Quality of life assessment | baseline | 
| EQ-5D-5L questionnaire | Quality of life assessment | week 6 | 
| 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 |