Back to resultsNon-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder (NaFS)
Primary Purpose
Frozen Shoulder, Depression
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Arthroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder
Eligibility Criteria
Inclusion Criteria:
- Shoulder arthroscopy
Exclusion Criteria:
- Active frozen shoulder
Sites / Locations
- Kantonsspital Baden
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Self-developed questionnaire
Adhereance to pain medication
PHQ 4 (Patient Health Questionnaire-4)
Depression scale
SMS (Self-Medicating Scale)
Patient's beliefs about self-medication
Secondary Outcome Measures
Full Information
NCT ID
NCT04758585
First Posted
February 11, 2021
Last Updated
February 16, 2021
Sponsor
Kantonsspital Baden
1. Study Identification
Unique Protocol Identification Number
NCT04758585
Brief Title
Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder
Acronym
NaFS
Official Title
Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder: A Case Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Baden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Active Comparator
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy
Intervention Description
Shoulder Arthroscopy
Primary Outcome Measure Information:
Title
Self-developed questionnaire
Description
Adhereance to pain medication
Time Frame
1 to 4 years postoperatively
Title
PHQ 4 (Patient Health Questionnaire-4)
Description
Depression scale
Time Frame
1 to 4 years postoperatively
Title
SMS (Self-Medicating Scale)
Description
Patient's beliefs about self-medication
Time Frame
1 to 4 years postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Shoulder arthroscopy
Exclusion Criteria:
Active frozen shoulder
Facility Information:
Facility Name
Kantonsspital Baden
City
Baden
State/Province
AG
ZIP/Postal Code
5404
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder
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