## Protocol Section
### Identification Module
**NCT ID:** NCT06429371

**Brief Title:** Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

**Official Title:** Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

#### Organization Study ID Info
**ID:** 8
#### Organization
**Class:** OTHER
**Full Name:** University of Central Florida
### Status Module
#### Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Florida

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Central Florida

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Shoulder Pain

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Quantitative Sensory Testing

- Other: Pain-Related Psychological Factors

**Label:** Individuals with Shoulder Pain

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Individuals with Shoulder Pain

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

**Name:** Quantitative Sensory Testing

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Individuals with Shoulder Pain

**Description:** Participants will complete psychological questionnaires to characterize these factors.

**Name:** Pain-Related Psychological Factors

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Heat pain Threshold

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Cold Pain Threshold

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Pressure Pain Threshold

**Time Frame:** Day 1

### Eligibility Module

**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, cryogobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* currently pregnant

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Individuals with shoulder pain

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Abigail.Wilson@ucf.edu

**Name:** Abigail W Anderson

**Phone:** 4078231026

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Orlando

**Country:** United States

**Facility:** University of Central Florida

**State:** Florida

**Zip:** 32765

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018771

- Term: Arthralgia

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M21907

- Name: Shoulder Pain

- Relevance: HIGH

- As Found: Shoulder Pain

- ID: M20833

- Name: Arthralgia

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020069

- Term: Shoulder Pain

### Misc Info Module

- Version Holder: 2024-05-31
