Education-based Physical Therapy Approach for Adhesive Capsulitis
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
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedStudy Start
First participant enrolled
September 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2019
CompletedAugust 10, 2017
August 1, 2017
2 years
August 8, 2017
August 8, 2017
Conditions
Outcome Measures
Primary Outcomes (17)
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 Outcomes (20)
EQ-5D-5L questionnaire
baseline
EQ-5D-5L questionnaire
week 6
EQ-5D-5L questionnaire
week 12
EQ-5D-5L questionnaire
week 18
EQ-5D-5L questionnaire
week 52
- +15 more secondary outcomes
Study Arms (2)
manual therapy and home-exercises
ACTIVE COMPARATORcorticoid injection + physiotherapy with a focus on manual therapy and home-exercises
education and supported home exercises
ACTIVE COMPARATORcorticosteroid injection + physiotherapy with focus on education and supported home exercises
Interventions
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
corticosteroid injection + physiotherapy with focus on education and supported home exercises
Eligibility Criteria
You may qualify if:
- % 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
You may not qualify if:
- bilateral frozen shoulder
- systemic and/or neurologic disease or a self-reported pathologic condition of the cervical/thoracic region, elbow or wrist/hand
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hasselt Universitylead
- Jessa Hospitalcollaborator
Study Sites (1)
Jessa Ziekenhuis
Hasselt, 3500, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liesbet De Baets, dr.
Hasselt University
- PRINCIPAL INVESTIGATOR
Annick Timmermans, prof. dr.
Hasselt University
- STUDY CHAIR
Carl Dierickx, prof. dr.
Jessa ziekenhuis, Universiteit Hasselt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr.
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 10, 2017
Study Start
September 4, 2017
Primary Completion
September 4, 2019
Study Completion
September 4, 2019
Last Updated
August 10, 2017
Record last verified: 2017-08