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Completed

NCT Number: NCT06467123

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

This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention 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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32765, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tissue Intervention

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

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.

Primary outcomes

  1. Report rate of adherence and adverse effects

    Time frame: through study completion, 4 weeks

    Number of participants who complete the study and adverse events will be reported

  2. Report preliminary outcomes of treatment effects

    Time frame: through study completion, 4 weeks

    Shoulder pain intensity measured with the numeric pain rating scale will be compared between groups.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 20, 2024
Registry last updated
Mar 5, 2025

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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