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Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder

NCT ID: NCT04758585

Last Updated: 2021-02-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-08-01

Brief Summary

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Background: Postoperative Frozen-Shoulder (FS) or adhesive capsulitis is a relatively frequent complication (5-20%), even after simple arthroscopic shoulder surgeries. The pathophysiology is still unclear, but psychological factors may play a pivotal role. From clinical experience, the investigators hypothesized that participants, who are reluctant to take medications, particularly "pain-killers", have an increased incidence of postoperative FS. The investigators retrospectively compared participants with and without postoperative FS by their attitude towards medication and by depression scale questionnaires.

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Detailed Description

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Conditions

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Frozen Shoulder Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

Group Type ACTIVE_COMPARATOR

Arthroscopy

Intervention Type PROCEDURE

Shoulder Arthroscopy

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arthroscopy

Shoulder Arthroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Shoulder arthroscopy

Exclusion Criteria

* Active frozen shoulder
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kantonsspital Baden

OTHER

Sponsor Role lead

Responsible Party

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Richard Niehaus

Dr.med. Richard Niehaus, senior consultant of shoulder surgery, principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ID 2019-01392

Identifier Type: -

Identifier Source: org_study_id

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