Education-based Physical Therapy Approach for Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03245476
• Other study ID #: 17.08/REVA17.01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 8, 2017
• Last updated: August 8, 2017
• Start date: September 4, 2017
• Est. completion date: September 4, 2019

Study information

• Verified date: August 2017
• Source: Hasselt University
• Contact: Liesbet De Baets, dr.
• Phone: +32 11 29 21 29
• Email: liesbet.debaets[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 4, 2019
• Est. primary completion date: September 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Periarthritis
• Rheumatic Diseases

Intervention

Other:
• Physical therapy focus on manual therapy and home-exercises
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
• Physical therapy focus on education and supported home exercises
corticosteroid injection + physiotherapy with focus on education and supported home exercises

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	baseline
Primary	Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 6
Primary	Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 12
Primary	Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 18
Primary	Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 52
Primary	Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	baseline
Primary	Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 6
Primary	Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 12
Primary	Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 18
Primary	Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 52
Secondary	EQ-5D-5L questionnaire	Quality of life assessment	baseline
Secondary	EQ-5D-5L questionnaire	Quality of life assessment	week 6
Secondary	EQ-5D-5L questionnaire	Quality of life assessment	week 12
Secondary	EQ-5D-5L questionnaire	Quality of life assessment	week 18
Secondary	EQ-5D-5L questionnaire	Quality of life assessment	week 52
Secondary	Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	baseline
Secondary	Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 6
Secondary	Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 12
Secondary	Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 18
Secondary	Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 52
Secondary	Tampa scale of kinesiophobia	this scale investigates fear of movement	baseline
Secondary	Tampa scale of kinesiophobia	this scale investigates fear of movement	week 6
Secondary	Tampa scale of kinesiophobia	this scale investigates fear of movement	week 12
Secondary	Tampa scale of kinesiophobia	this scale investigates fear of movement	week 18
Secondary	Tampa scale of kinesiophobia	this scale investigates fear of movement	week 52
Secondary	Hospital anxiety and depression scale	this scale investigates anxiety and depression	baseline
Secondary	Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 6
Secondary	Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 12
Secondary	Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 18
Secondary	Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 52

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