Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06429371
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Central Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Abigail Anderson
Principal Investigator Affiliation University of Central Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Shoulder Pain
Arms & Interventions

Arms

: Individuals with Shoulder Pain

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

Interventions

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.

Other: - Pain-Related Psychological Factors

Participants will complete psychological questionnaires to characterize these factors.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Central Florida, Orlando, Florida

Status

Recruiting

Address

University of Central Florida

Orlando, Florida, 32765

Site Contact

Abigail Wilson

[email protected]

4078231026