Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

NCT06429371 | Completed

• 1 other identifier: 8
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Individuals with Shoulder Pain

Individuals with shoulder pain that is at least 3/10 within the past 24 hours.

Other: Quantitative Sensory Testing; Other: Pain-Related Psychological Factors

Interventions

Quantitative Sensory Testing OTHER

Participants will undergo heat pain threshold, cold pain threshold, pressure pain threshold, temporal summation, and conditioned pain modulation to characterize pain sensitivity.

Individuals with Shoulder Pain

Pain-Related Psychological Factors OTHER

Participants will complete psychological questionnaires to characterize these factors.

Individuals with Shoulder Pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with shoulder pain

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead
• University of Florida: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32765, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abigail Anderson

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 28, 2024
• Study Start: May 24, 2024
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)