Education-based Physical Therapy Approach for Adhesive Capsulitis

Hasselt University100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Adhesive Capsulitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: week 6

Scapulothoracic, glenohumeral and elbow joint range of motion

Time frame: week 12

Scapulothoracic, glenohumeral and elbow joint range of motion

Time frame: week 18

Scapulothoracic, glenohumeral and elbow joint range of motion

Time frame: 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.

Time frame: 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.

Time frame: week 18

Disability of the shoulder, elbow and hand questionnaire

assessment of upper limb function

Time frame: baseline

Disability of the shoulder, elbow and hand questionnaire

assessment of upper limb function

Time frame: week 6

Disability of the shoulder, elbow and hand questionnaire

assessment of upper limb function

Time frame: week 12

Disability of the shoulder, elbow and hand questionnaire

assessment of upper limb function

Time frame: week 18

Disability of the shoulder, elbow and hand questionnaire

assessment of upper limb function

Time frame: week 52

Brief pain inventory

assessment of current, worst and night pain on a 11 point likert scale

Time frame: baseline

Brief pain inventory

assessment of current, worst and night pain on a 11 point likert scale

Time frame: week 6

Brief pain inventory

assessment of current, worst and night pain on a 11 point likert scale

Time frame: week 12

Brief pain inventory

assessment of current, worst and night pain on a 11 point likert scale

Time frame: week 18

Brief pain inventory

assessment of current, worst and night pain on a 11 point likert scale

Time frame: week 52

Secondary Outcomes

EQ-5D-5L questionnaire

Quality of life assessment

Time frame: baseline

EQ-5D-5L questionnaire

Quality of life assessment

Time frame: week 6

EQ-5D-5L questionnaire

Quality of life assessment

Time frame: week 12

EQ-5D-5L questionnaire

Quality of life assessment

Time frame: week 18

EQ-5D-5L questionnaire

Quality of life assessment

Time frame: week 52

Self-efficacy questionnaire