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Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06429371
Enrollment
60
Registered
2024-05-28
Start date
2024-05-24
Completion date
2026-04-20
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

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.

Interventions

OTHERQuantitative Sensory Testing

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

OTHERPain-Related Psychological Factors

Participants will complete psychological questionnaires to characterize these factors.

Sponsors

University of Central Florida
Lead SponsorOTHER
University of Florida
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Heat pain ThresholdDay 1A 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 ThresholdDay 1A 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 ThresholdDay 1An 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAbigail Anderson

University of Central Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026