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NCT06467123 Clinical Trial

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

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06467123
Other study ID # 9
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 24, 2024
Est. completion date May 30, 2025

Study information
Verified date June 2024
Source University of Central Florida
Contact Abigail Anderson
Phone 4078231026
Email Abigail.Wilson@ucf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date May 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Tissue 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.
• 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Central Florida

Outcome
Type Measure Description Time frame Safety issue
Primary Report rate of adherence and adverse effects Number of participants who complete the study and adverse events will be reported through study completion, 4 weeks
Primary Report preliminary outcomes of treatment effects Shoulder pain intensity measured with the numeric pain rating scale will be compared between groups. through study completion, 4 weeks
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