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

Depression Clinical Trial

— NaFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04758585
• Other study ID #: ID 2019-01392
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: February 2021
• Source: Kantonsspital Baden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Shoulder arthroscopy

Exclusion Criteria:

• Active frozen shoulder

Related Conditions & MeSH terms

• Bursitis
• Depression
• Frozen Shoulder

Intervention

Procedure:
• Arthroscopy
Shoulder Arthroscopy

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden	AG

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Baden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-developed questionnaire	Adhereance to pain medication	1 to 4 years postoperatively
Primary	PHQ 4 (Patient Health Questionnaire-4)	Depression scale	1 to 4 years postoperatively
Primary	SMS (Self-Medicating Scale)	Patient's beliefs about self-medication	1 to 4 years postoperatively