NCT06467123

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

June 14, 2024

Last Update Submit

February 28, 2025

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (2)

  • Report rate of adherence and adverse effects

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

    through study completion, 4 weeks

  • Report preliminary outcomes of treatment effects

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

    through study completion, 4 weeks

Study Arms (2)

Tissue Intervention

EXPERIMENTAL

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.

Other: Tissue Intervention

Biopsychosocial Intervention

ACTIVE COMPARATOR

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.

Other: Biopsychosocial Intervention

Interventions

Tissue InterventionOTHER

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.

Tissue Intervention
Biopsychosocial InterventionOTHER

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32765, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abigail Anderson

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

June 28, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

March 5, 2025

Record last verified: 2025-02

Locations

US(1)