NCT04758585

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 11, 2021

Last Update Submit

February 16, 2021

Conditions

Frozen ShoulderDepression

Outcome Measures

Primary Outcomes (3)

  • Self-developed questionnaire

    Adhereance to pain medication

    1 to 4 years postoperatively

  • PHQ 4 (Patient Health Questionnaire-4)

    Depression scale

    1 to 4 years postoperatively

  • SMS (Self-Medicating Scale)

    Patient's beliefs about self-medication

    1 to 4 years postoperatively

Study Arms (2)

Study Group

ACTIVE COMPARATOR
Procedure: Arthroscopy

Control Group

NO INTERVENTION

Interventions

ArthroscopyPROCEDURE

Shoulder Arthroscopy

Study Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Shoulder arthroscopy

You may not qualify if:

  • Active frozen shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

MeSH Terms

Conditions

BursitisDepression

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med. Richard Niehaus, senior consultant of shoulder surgery, principle investigator

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 17, 2021

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

August 1, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)