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Education-based Physical Therapy Approach for Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Physical therapy focus on manual therapy and home-exercises
Physical therapy focus on education and supported home exercises
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jessa Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

manual therapy and home-exercises

education and supported home exercises

Arm Description

corticoid injection + physiotherapy with a focus on manual therapy and home-exercises

corticosteroid injection + physiotherapy with focus on education and supported home exercises

Outcomes

Primary Outcome Measures

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
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
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
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
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
parameters on arthrographic investigation by means of MRI
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
parameters on arthrographic investigation by means of MRI
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale

Secondary Outcome Measures

EQ-5D-5L questionnaire
Quality of life assessment
EQ-5D-5L questionnaire
Quality of life assessment
EQ-5D-5L questionnaire
Quality of life assessment
EQ-5D-5L questionnaire
Quality of life assessment
EQ-5D-5L questionnaire
Quality of life assessment
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Tampa scale of kinesiophobia
this scale investigates fear of movement
Tampa scale of kinesiophobia
this scale investigates fear of movement
Tampa scale of kinesiophobia
this scale investigates fear of movement
Tampa scale of kinesiophobia
this scale investigates fear of movement
Tampa scale of kinesiophobia
this scale investigates fear of movement
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Hospital anxiety and depression scale
this scale investigates anxiety and depression

Full Information

First Posted
August 8, 2017
Last Updated
August 8, 2017
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03245476
Brief Title
Education-based Physical Therapy Approach for Adhesive Capsulitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2017 (Anticipated)
Primary Completion Date
September 4, 2019 (Anticipated)
Study Completion Date
September 4, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
manual therapy and home-exercises
Arm Type
Active Comparator
Arm Description
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
Arm Title
education and supported home exercises
Arm Type
Active Comparator
Arm Description
corticosteroid injection + physiotherapy with focus on education and supported home exercises
Intervention Type
Other
Intervention Name(s)
Physical therapy focus on manual therapy and home-exercises
Intervention Description
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
Intervention Type
Other
Intervention Name(s)
Physical therapy focus on education and supported home exercises
Intervention Description
corticosteroid injection + physiotherapy with focus on education and supported home exercises
Primary Outcome Measure Information:
Title
Scapulothoracic, glenohumeral and elbow joint range of motion
Description
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
Time Frame
baseline
Title
Scapulothoracic, glenohumeral and elbow joint range of motion
Description
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
Time Frame
week 6
Title
Scapulothoracic, glenohumeral and elbow joint range of motion
Description
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
Time Frame
week 12
Title
Scapulothoracic, glenohumeral and elbow joint range of motion
Description
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
Time Frame
week 18
Title
Scapulothoracic, glenohumeral and elbow joint range of motion
Description
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
Time Frame
week 52
Title
parameters on arthrographic investigation by means of MRI
Description
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Time Frame
baseline
Title
parameters on arthrographic investigation by means of MRI
Description
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Time Frame
week 18
Title
Disability of the shoulder, elbow and hand questionnaire
Description
assessment of upper limb function
Time Frame
baseline
Title
Disability of the shoulder, elbow and hand questionnaire
Description
assessment of upper limb function
Time Frame
week 6
Title
Disability of the shoulder, elbow and hand questionnaire
Description
assessment of upper limb function
Time Frame
week 12
Title
Disability of the shoulder, elbow and hand questionnaire
Description
assessment of upper limb function
Time Frame
week 18
Title
Disability of the shoulder, elbow and hand questionnaire
Description
assessment of upper limb function
Time Frame
week 52
Title
Brief pain inventory
Description
assessment of current, worst and night pain on a 11 point likert scale
Time Frame
baseline
Title
Brief pain inventory
Description
assessment of current, worst and night pain on a 11 point likert scale
Time Frame
week 6
Title
Brief pain inventory
Description
assessment of current, worst and night pain on a 11 point likert scale
Time Frame
week 12
Title
Brief pain inventory
Description
assessment of current, worst and night pain on a 11 point likert scale
Time Frame
week 18
Title
Brief pain inventory
Description
assessment of current, worst and night pain on a 11 point likert scale
Time Frame
week 52
Secondary Outcome Measure Information:
Title
EQ-5D-5L questionnaire
Description
Quality of life assessment
Time Frame
baseline
Title
EQ-5D-5L questionnaire
Description
Quality of life assessment
Time Frame
week 6
Title
EQ-5D-5L questionnaire
Description
Quality of life assessment
Time Frame
week 12
Title
EQ-5D-5L questionnaire
Description
Quality of life assessment
Time Frame
week 18
Title
EQ-5D-5L questionnaire
Description
Quality of life assessment
Time Frame
week 52
Title
Self-efficacy questionnaire
Description
this questionnaire assesses the self-efficacy of a person
Time Frame
baseline
Title
Self-efficacy questionnaire
Description
this questionnaire assesses the self-efficacy of a person
Time Frame
week 6
Title
Self-efficacy questionnaire
Description
this questionnaire assesses the self-efficacy of a person
Time Frame
week 12
Title
Self-efficacy questionnaire
Description
this questionnaire assesses the self-efficacy of a person
Time Frame
week 18
Title
Self-efficacy questionnaire
Description
this questionnaire assesses the self-efficacy of a person
Time Frame
week 52
Title
Tampa scale of kinesiophobia
Description
this scale investigates fear of movement
Time Frame
baseline
Title
Tampa scale of kinesiophobia
Description
this scale investigates fear of movement
Time Frame
week 6
Title
Tampa scale of kinesiophobia
Description
this scale investigates fear of movement
Time Frame
week 12
Title
Tampa scale of kinesiophobia
Description
this scale investigates fear of movement
Time Frame
week 18
Title
Tampa scale of kinesiophobia
Description
this scale investigates fear of movement
Time Frame
week 52
Title
Hospital anxiety and depression scale
Description
this scale investigates anxiety and depression
Time Frame
baseline
Title
Hospital anxiety and depression scale
Description
this scale investigates anxiety and depression
Time Frame
week 6
Title
Hospital anxiety and depression scale
Description
this scale investigates anxiety and depression
Time Frame
week 12
Title
Hospital anxiety and depression scale
Description
this scale investigates anxiety and depression
Time Frame
week 18
Title
Hospital anxiety and depression scale
Description
this scale investigates anxiety and depression
Time Frame
week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liesbet De Baets, dr.
Phone
+32 11 29 21 29
Email
liesbet.debaets@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Annick Timmermans, prof. dr.
Email
annick.timmermans@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liesbet De Baets, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Annick Timmermans, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carl Dierickx, prof. dr.
Organizational Affiliation
Jessa ziekenhuis, Universiteit Hasselt
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liesbet De Baets, dr.
Phone
+32 11 29 21 29
Email
liesbet.debaets@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Carl Dierickx
Email
carl.dierickx@jessazh.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Education-based Physical Therapy Approach for Adhesive Capsulitis

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