Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

Recruiting

• Conditions: Shoulder Pain
• Interventions: Other: Quantitative Sensory Testing; Other: Pain-Related Psychological Factors

• Registration Number: NCT06429371
• Lead Sponsor: University of Central Florida

Brief Summary

Irritability was defined by Geoffrey Maitland as the vigor of activity to provoke symptoms, the severity of symptoms, and time for symptoms to subside. Irritability is deeply embedded in the physical therapy clinical decision-making process. However, the mechanisms contributing to irritability are unknown. Therefore, the purpose of this study is to characterize pain sensitivity and pain-related psychological factors by irritability level in individuals with shoulder pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-29
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-23
• Study Start: 2024-05-24
• Study First Posted: 2024-05-28
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• shoulder pain symptom intensity rated as 3/10 or higher in the past 24 hours
• attending physical therapy for shoulder pain

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
• history of a chronic pain condition, such as fibromyalgia
• blood clotting disorder, such as hemophilia
• contraindication to the application of ice (blood pressure > 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
• currently pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with Shoulder Pain	Pain-Related Psychological Factors	Individuals with shoulder pain that is at least 3/10 within the past 24 hours.
Individuals with Shoulder Pain	Quantitative Sensory Testing	Individuals with shoulder pain that is at least 3/10 within the past 24 hours.

Primary Outcome Measures

Name	Time	Method
Heat pain Threshold	Day 1	A thermode will be applied to the deltoid, tibialis anterior, and lower back. The thermode will gradually increase temperature until the sensation changes from comfortable warmth to pain (pain threshold). Once pain threshold is reached, the temperature in degrees Celsius for heat pain threshold is recorded.
Cold Pain Threshold	Day 1	A thermode will be applied to the deltoid, tibialis anterior, and lower back. The thermode will gradually decrease temperature until the sensation changes from comfortable cold to pain (pain threshold). Once pain threshold is reached, the temperature in degrees Celsius for cold pain threshold is recorded.
Pressure Pain Threshold	Day 1	An algometer will be applied to the deltoid, tibialis anterior, and lower back. Pressure will be gradually applied until the sensation changes from comfortable pressure to pain (pain threshold). Once pain threshold is reached, the pressure in kilopascals will be recorded for pressure pain threshold.

Trial Locations

Locations (1)

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