Education-based Physical Therapy Approach for Adhesive Capsulitis

NCT ID: NCT03245476

Last Updated: 2017-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2019-09-04

Brief Summary

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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

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Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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manual therapy and home-exercises

corticoid injection + physiotherapy with a focus on manual therapy and home-exercises

Group Type ACTIVE_COMPARATOR

Physical therapy focus on manual therapy and home-exercises

Intervention Type OTHER

corticoid injection + physiotherapy with a focus on manual therapy and home-exercises

education and supported home exercises

corticosteroid injection + physiotherapy with focus on education and supported home exercises

Group Type ACTIVE_COMPARATOR

Physical therapy focus on education and supported home exercises

Intervention Type OTHER

corticosteroid injection + physiotherapy with focus on education and supported home exercises

Interventions

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Physical therapy focus on manual therapy and home-exercises

corticoid injection + physiotherapy with a focus on manual therapy and home-exercises

Intervention Type OTHER

Physical therapy focus on education and supported home exercises

corticosteroid injection + physiotherapy with focus on education and supported home exercises

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Annick Timmermans

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liesbet De Baets, dr.

Role: STUDY_CHAIR

Hasselt University

Annick Timmermans, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Carl Dierickx, prof. dr.

Role: STUDY_CHAIR

Jessa ziekenhuis, Universiteit Hasselt

Locations

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Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Liesbet De Baets, dr.

Role: CONTACT

+32 11 29 21 29

Annick Timmermans, prof. dr.

Role: CONTACT

Facility Contacts

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Liesbet De Baets, dr.

Role: primary

+32 11 29 21 29

Carl Dierickx

Role: backup

Other Identifiers

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17.08/REVA17.01

Identifier Type: -

Identifier Source: org_study_id

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