A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain

NCT ID: NCT06467123

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-28

Study Completion Date

2025-02-28

Brief Summary

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This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.

Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tissue Intervention

Participants will attend eight sessions. During each session, participants will receive education on positions of comfort, progressing activities, and return to function. Participants will complete shoulder stretching and strengthening exercises according to a protocol.

Group Type EXPERIMENTAL

Tissue Intervention

Intervention Type OTHER

Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.

Biopsychosocial Intervention

Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.

Group Type ACTIVE_COMPARATOR

Biopsychosocial Intervention

Intervention Type OTHER

Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.

Interventions

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Tissue Intervention

Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.

Intervention Type OTHER

Biopsychosocial Intervention

Participants will attend eight sessions. During each session, participants will receive education on pain neuroscience education, stress management, and maintaining physical activity. Participants will complete shoulder stretching and strengthening exercises according to a graded exercise protocol.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Shoulder pain intensity rated as 3/10 or higher in the past 24 hours

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
* 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)
* Unable to exercise without a medical clearance (assessed on the PAR-Q+ on the first visit)
* Exceed pressure and sensory safety thresholds (assessed on the first visit)
* Categorized as low irritability (assessed on the first visit)
* currently pregnant
* currently receiving physical therapy to treat shoulder pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Abigail Wilson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abigail Anderson

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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University of Central Florida

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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9

Identifier Type: -

Identifier Source: org_study_id

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