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

February 16, 2021 updated by: Richard Niehaus, Kantonsspital Baden

Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder: A Case Control Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • AG
      • Baden, AG, Switzerland, 5404
        • Kantonsspital Baden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shoulder arthroscopy

Exclusion Criteria:

  • Active frozen shoulder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
ACTIVE_COMPARATOR: Study Group
Procedure: Arthroscopy
Shoulder Arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-developed questionnaire
Time Frame: 1 to 4 years postoperatively
Adhereance to pain medication
1 to 4 years postoperatively
PHQ 4 (Patient Health Questionnaire-4)
Time Frame: 1 to 4 years postoperatively
Depression scale
1 to 4 years postoperatively
SMS (Self-Medicating Scale)
Time Frame: 1 to 4 years postoperatively
Patient's beliefs about self-medication
1 to 4 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Baden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (ACTUAL)

February 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 2019-01392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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