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Education-based Physical Therapy Approach for Adhesive Capsulitis

H

Hasselt University

Status

Unknown

Conditions

Adhesive Capsulitis

Treatments

Other: Physical therapy focus on education and supported home exercises
Other: Physical therapy focus on manual therapy and home-exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT03245476
17.08/REVA17.01

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

manual therapy and home-exercises
Active Comparator group
Description:
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
Treatment:
Other: Physical therapy focus on manual therapy and home-exercises
education and supported home exercises
Active Comparator group
Description:
corticosteroid injection + physiotherapy with focus on education and supported home exercises
Treatment:
Other: Physical therapy focus on education and supported home exercises

Trial contacts and locations

1

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Central trial contact

Annick Timmermans, prof. dr.; Liesbet De Baets, dr.

Data sourced from clinicaltrials.gov

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