Education-based Physical Therapy Approach for Adhesive Capsulitis

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

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 Overview

• Status: Unknown
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Other: Physical therapy focus on manual therapy and home-exercises; Other: Physical therapy focus on education and supported home exercises

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liesbet De Baets, dr.; Phone Number: +32 11 29 21 29; Email: liesbet.debaets@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis
    • Contact: Liesbet De Baets, dr.; Phone Number: +32 11 29 21 29; Email: liesbet.debaets@uhasselt.be
    • Contact: Carl Dierickx; Email: carl.dierickx@jessazh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: manual therapy and home-exercises; corticoid injection + physiotherapy with a focus on manual therapy and home-exercises	Other: Physical therapy focus on manual therapy and home-exercises; corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
Active Comparator: education and supported home exercises; corticosteroid injection + physiotherapy with focus on education and supported home exercises	Other: Physical therapy focus on education and supported home exercises; corticosteroid injection + physiotherapy with focus on education and supported home exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	baseline
Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 6
Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 12
Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 18
Disability of the shoulder, elbow and hand questionnaire	assessment of upper limb function	week 52
Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	baseline
Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 6
Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 12
Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 18
Brief pain inventory	assessment of current, worst and night pain on a 11 point likert scale	week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L questionnaire	Quality of life assessment	baseline
EQ-5D-5L questionnaire	Quality of life assessment	week 6
EQ-5D-5L questionnaire	Quality of life assessment	week 12
EQ-5D-5L questionnaire	Quality of life assessment	week 18
EQ-5D-5L questionnaire	Quality of life assessment	week 52
Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	baseline
Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 6
Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 12
Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 18
Self-efficacy questionnaire	this questionnaire assesses the self-efficacy of a person	week 52
Tampa scale of kinesiophobia	this scale investigates fear of movement	baseline
Tampa scale of kinesiophobia	this scale investigates fear of movement	week 6
Tampa scale of kinesiophobia	this scale investigates fear of movement	week 12
Tampa scale of kinesiophobia	this scale investigates fear of movement	week 18
Tampa scale of kinesiophobia	this scale investigates fear of movement	week 52
Hospital anxiety and depression scale	this scale investigates anxiety and depression	baseline
Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 6
Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 12
Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 18
Hospital anxiety and depression scale	this scale investigates anxiety and depression	week 52

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Study Chair: Liesbet De Baets, dr., Hasselt University; Principal Investigator: Annick Timmermans, prof. dr., Hasselt University; Study Chair: Carl Dierickx, prof. dr., Jessa ziekenhuis, Universiteit Hasselt

Study record dates

Study Major Dates

• Study Start (Anticipated): September 4, 2017
• Primary Completion (Anticipated): September 4, 2019
• Study Completion (Anticipated): September 4, 2019

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 17.08/REVA17.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No