A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Other: Tissue Intervention; Other: Biopsychosocial Intervention

• Registration Number: NCT06467123
• Lead Sponsor: University of Central Florida

Brief Summary

This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-20
• Study Start: 2024-06-28
• Status Verified: 2025-02
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Shoulder pain intensity rated as 3/10 or higher in the past 24 hours

Exclusion Criteria

• Non-English speaking
• Systemic medical conditions that affect sensation, such as uncontrolled diabetes
• History of shoulder surgery or fracture within the past 6 months
• blood clotting disorder, such as hemophilia
• contraindication to the application of ice ((blood pressure > 140/90 mmHg, cold urticaria, cryogobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
• Unable to exercise without a medical clearance (assessed on the PAR-Q+ on the first visit)
• Exceed pressure and sensory safety thresholds (assessed on the first visit)
• Categorized as low irritability (assessed on the first visit)
• currently pregnant
• currently receiving physical therapy to treat shoulder pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tissue Intervention	Tissue Intervention	Participants will attend eight sessions. During each session, participants will receive education on positions of comfort, progressing activities, and return to function. Participants will complete shoulder stretching and strengthening exercises according to a protocol.
Biopsychosocial Intervention	Biopsychosocial Intervention	Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.

Primary Outcome Measures

Name	Time	Method
Report preliminary outcomes of treatment effects	through study completion, 4 weeks	Shoulder pain intensity measured with the numeric pain rating scale will be compared between groups.
Report rate of adherence and adverse effects	through study completion, 4 weeks	Number of participants who complete the study and adverse events will be reported

Trial Locations

Locations (1)

University of Central Florida; 🇺🇸 Orlando, Florida, United States