Patient Education and Sling Use After Shoulder Surgery

NCT07851233 | Enrolling By Invitation

• 1 other identifier: MBIS2024-1306
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether educational pamphlets can help patients safely manage personal hygiene, household activities, and female-specific self-care while wearing a sling after surgery. The study will also examine whether following sling-use instructions is associated with better short-term recovery and patient-reported outcomes for up to 6 months after surgery.

Conditions

Rotator Cuff Tear; Sling; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Sling adherence

  Sling adherence will be assessed using patient-reported survey responses regarding adherence to prescribed shoulder sling use during the postoperative period.

  4 to 6 weeks after surgery

Secondary Outcomes (1)

• Patient-reported shoulder function

  6 months after surgery

Other Outcomes (3)

• Patient-reported shoulder status

  6 months after surgery

• Patient experience while wearing a shoulder sling

  6 weeks after surgery

• Preparedness for postoperative activities

  6 weeks after surgery

Study Arms (2)

Control Group - Standard postoperative education

ACTIVE COMPARATOR

Standard postoperative education

Behavioral: Control - Standard Postoperative Education

Pamphlet Intervention Group

ACTIVE COMPARATOR

Standard postoperative education + "Living with a Sling" educational pamphlets

Behavioral: Intervention - Living with a Sling Educational Pamphlets

Interventions

Control - Standard Postoperative Education BEHAVIORAL

Participants will receive the standard postoperative education and instructions provided by their treating orthopedic physician for patients undergoing shoulder surgery requiring postoperative sling use.

Control Group - Standard postoperative education

Intervention - Living with a Sling Educational Pamphlets BEHAVIORAL

Participants will receive standard postoperative education plus educational pamphlets providing guidance on performing daily activities while wearing a shoulder sling. The pamphlets address personal hygiene, household tasks, and self-care. Female participants will also receive a pamphlet addressing female-specific self-care.

Pamphlet Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants scheduled to undergo shoulder surgery at Rothman Orthopaedics that requires more than 1 week of postoperative shoulder sling use.
• Participants who are able to provide informed consent.
• Participants who have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.

You may not qualify if:

• Participants undergoing shoulder surgery that does not require more than 1 week of postoperative shoulder sling use.
• Participants who do not have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: October 1, 2026
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

US (1)