Clinical trial NCT03245476: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2017-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
timeFrame: baseline
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
timeFrame: week 6
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
timeFrame: week 12
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
timeFrame: week 18
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
timeFrame: week 52
measure: parameters on arthrographic investigation by means of MRI
timeFrame: baseline
measure: parameters on arthrographic investigation by means of MRI
timeFrame: week 18
measure: Disability of the shoulder, elbow and hand questionnaire
timeFrame: baseline
measure: Disability of the shoulder, elbow and hand questionnaire
timeFrame: week 6
measure: Disability of the shoulder, elbow and hand questionnaire
timeFrame: week 12
measure: Disability of the shoulder, elbow and hand questionnaire
timeFrame: week 18
measure: Disability of the shoulder, elbow and hand questionnaire
timeFrame: week 52
measure: Brief pain inventory
timeFrame: baseline
measure: Brief pain inventory
timeFrame: week 6
measure: Brief pain inventory
timeFrame: week 12
measure: Brief pain inventory
timeFrame: week 18
measure: Brief pain inventory
timeFrame: week 52
Secondary outcomes:
measure: EQ-5D-5L questionnaire
timeFrame: baseline
measure: EQ-5D-5L questionnaire
timeFrame: week 6
measure: EQ-5D-5L questionnaire
timeFrame: week 12
measure: EQ-5D-5L questionnaire
timeFrame: week 18
measure: EQ-5D-5L questionnaire
timeFrame: week 52
measure: Self-efficacy questionnaire
timeFrame: baseline
measure: Self-efficacy questionnaire
timeFrame: week 6
measure: Self-efficacy questionnaire
timeFrame: week 12
measure: Self-efficacy questionnaire
timeFrame: week 18
measure: Self-efficacy questionnaire
timeFrame: week 52
measure: Tampa scale of kinesiophobia
timeFrame: baseline
measure: Tampa scale of kinesiophobia
timeFrame: week 6
measure: Tampa scale of kinesiophobia
timeFrame: week 12
measure: Tampa scale of kinesiophobia
timeFrame: week 18
measure: Tampa scale of kinesiophobia
timeFrame: week 52
measure: Hospital anxiety and depression scale
timeFrame: baseline
measure: Hospital anxiety and depression scale
timeFrame: week 6
measure: Hospital anxiety and depression scale
timeFrame: week 12
measure: Hospital anxiety and depression scale
timeFrame: week 18
measure: Hospital anxiety and depression scale
timeFrame: week 52
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Liesbet De Baets, dr.
role: STUDY_CHAIR
affiliation: Hasselt University
name: Annick Timmermans, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jessa ziekenhuis, Universiteit Hasselt
name: Carl Dierickx, prof. dr.
role: STUDY_CHAIR
References: