Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429371
• Other study ID #: 8
• Status: Recruiting
• Start date: May 24, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: May 2024
• Source: University of Central Florida
• Contact: Abigail W Anderson
• Phone: 4078231026
• Email: Abigail.Wilson[@]ucf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Quantitative Sensory Testing
Participants will undergo heat pain threshold, cold pain threshold, pressure pain threshold, temporal summation, and conditioned pain modulation to characterize pain sensitivity.
• Pain-Related Psychological Factors
Participants will complete psychological questionnaires to characterize these factors.

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heat pain Threshold	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.	Day 1
Primary	Cold Pain Threshold	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.	Day 1
Primary	Pressure Pain Threshold	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.	Day 1