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OpenTrials
Completed

NCT Number: NCT06429371

Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Central Florida

Orlando, Florida, 32765, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Pain-Related Psychological Factors

Other

Participants will complete psychological questionnaires to characterize these factors.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • University of Florida

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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