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Clinical Trials/NCT06429371
NCT06429371
Completed
Not Applicable

Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

University of Central Florida2 sites in 1 country60 target enrollmentMay 24, 2024

Overview

Phase
Not Applicable
Intervention
Quantitative Sensory Testing
Conditions
Shoulder Pain
Sponsor
University of Central Florida
Enrollment
60
Locations
2
Primary Endpoint
Heat pain Threshold
Status
Completed
Last Updated
4 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 24, 2024
End Date
April 20, 2026
Last Updated
4 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Individuals with Shoulder Pain

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

Intervention: Quantitative Sensory Testing

Individuals with Shoulder Pain

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

Intervention: Pain-Related Psychological Factors

Outcomes

Primary Outcomes

Heat pain Threshold

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (2)

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