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

• Sponsor: Kantonsspital Baden (Other)
• Overall Status: Completed
• CT.gov ID: NCT04758585
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 31
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Frozen Shoulder; Depression	Procedure: Arthroscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder: A Case Control Study
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study Group	Procedure: Arthroscopy; Shoulder Arthroscopy
No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

1. Self-developed questionnaire [1 to 4 years postoperatively]

   Adhereance to pain medication

2. PHQ 4 (Patient Health Questionnaire-4) [1 to 4 years postoperatively]

   Depression scale

3. SMS (Self-Medicating Scale) [1 to 4 years postoperatively]

   Patient's beliefs about self-medication

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Shoulder arthroscopy

Exclusion Criteria:

• Active frozen shoulder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Baden	Baden	AG	Switzerland	5404

Sponsors and Collaborators

• Kantonsspital Baden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Niehaus, Dr.med. Richard Niehaus, senior consultant of shoulder surgery, principle investigator, Kantonsspital Baden
• ClinicalTrials.gov Identifier: NCT04758585
• Other Study ID Numbers: ID 2019-01392
• First Posted: Feb 17, 2021
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bursitis

Study Results

No Results Posted as of Feb 17, 2021