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

June 28, 2024 updated by: Abigail Wilson, University of Central Florida
This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, 4 weeks
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.
through study completion, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Investigators

  • Principal Investigator: Abigail Anderson, University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Estimated)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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