Education-based Physical Therapy Approach for Adhesive Capsulitis

Not Applicable

• Conditions: Adhesive Capsulitis
• Interventions: Other: Physical therapy focus on education and supported home exercises; Other: Physical therapy focus on manual therapy and home-exercises

• Registration Number: NCT03245476
• Lead Sponsor: Hasselt University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Last Update Submitted: 2017-08-08
• Study First Posted: 2017-08-10
• Last Update Posted: 2017-08-10
• Study Start: 2017-09-04
• Primary Completion: 2019-09-04
• Study Completion: 2019-09-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
education and supported home exercises	Physical therapy focus on education and supported home exercises	corticosteroid injection + physiotherapy with focus on education and supported home exercises
manual therapy and home-exercises	Physical therapy focus on manual therapy and home-exercises	corticoid injection + physiotherapy with a focus on manual therapy and home-exercises

Primary Outcome Measures

Name	Time	Method
parameters on arthrographic investigation by means of MRI	week 18	the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Scapulothoracic, glenohumeral and elbow joint range of motion	week 52	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
Disability of the shoulder, elbow and hand questionnaire	week 52	assessment of upper limb function
Brief pain inventory	week 52	assessment of current, worst and night pain on a 11 point likert scale

Secondary Outcome Measures

Name	Time	Method
Tampa scale of kinesiophobia	week 52	this scale investigates fear of movement
Hospital anxiety and depression scale	week 52	this scale investigates anxiety and depression
EQ-5D-5L questionnaire	week 52	Quality of life assessment
Self-efficacy questionnaire	week 52	this questionnaire assesses the self-efficacy of a person

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium