Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.

NCT07489937 | Recruiting

• 1 other identifier: IRB202501875
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand acute tendon changes after two exercise programs. We will invite individuals with and without shoulder pain to participate in this study. Every individual will participate in both exercise programs separated by up to 15 days. The researcher will evaluate the shoulder tendon using ultrasound before each exercise program and at 1 hour, 6 hours and 24 hours after each exercise program. The researcher will also evaluate self reported pain, pain sensitivity testing, and self reported questionnaires. We will compare the tendon changes after each exercise program, as well as between participants with and without shoulder pain.

Conditions

Shoulder Pain; Healthy Adult

Keywords

rotator cuff related shoulder pain; rotator cuff tendinopathy; shoulder pain; tendon thickness; exercise; subacromial pain; ultrasound

Outcome Measures

Primary Outcomes (1)

• Supraspinatus tendon thickness

  The investigators will use ultrasound to take pictures of the supraspinatus tendons. Established ultrasound procedures will be used to measure supraspinatus tendon thickness.

  From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.

Secondary Outcomes (2)

• Pain sensitivity testing

  From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.

• Self-reported pain

  From enrollment to 1, 6, and 24 hours after each exercise program.

Other Outcomes (8)

• Rate of perceived exertion

  Immediately after each exercise program.

• Pennsylvania Shoulder Score (PENN)

  At baseline before each exercise program.

• Optimal Screening for Prediction of Referral and Outcome (OSPRO)

  At baseline before the first exercise program.

Study Arms (2)

Isotonic exercise then Plyometric exercise

EXPERIMENTAL

Behavioral: Isotonic exercise program; Behavioral: Plyometric exercise program

Plyometric exercise then Isotonic exercise

EXPERIMENTAL

Behavioral: Isotonic exercise program; Behavioral: Plyometric exercise program

Interventions

Isotonic exercise program BEHAVIORAL

Participants will perform two isotonic exercises, prone shoulder external rotation and shoulder elevation. The exercises will be performed at a pace of 2-second for both concentric and eccentric phases. For each exercise, participants will perform two sets of 8 repetitions, followed by a third set performed until fatigue. Fatigue will be determined using the Repetition in Reserve Scale, which asks the participant to perform exercises until they reach a self-selected number corresponding to the number of repetitions left that a participant could still complete if needed. We will ask participants to continue the third set until they reach a Repetition in Reserve number of 1. The rest period will be 30 seconds between sets and 2 minutes between exercises. The exercise load will be selected after manual maximal isometric strength testing using a handheld dynamometer. A 40% of the strength testing will be used for exercises in both groups following strength guidelines.

Isotonic exercise then Plyometric exercise; Plyometric exercise then Isotonic exercise

Plyometric exercise program BEHAVIORAL

Participants will perform two isotonic exercises, prone shoulder external rotation and shoulder elevation. The exercises will be performed at a pace of 1-second for the eccentric phases followed by an explosive concentric phase. For each exercise, participants will perform two sets of 8 repetitions, followed by a third set performed until fatigue. Fatigue will be determined using the Repetition in Reserve Scale, which asks the participant to perform exercises until they reach a self-selected number corresponding to the number of repetitions left that a participant could still complete if needed. Participants will complete the third set until they reach a Repetition in Reserve number of 1. The rest period will be 30 seconds between sets and 2 minutes between exercises. The exercise load will be selected after manual maximal isometric strength testing using a handheld dynamometer. A 40% of the strength testing will be used for exercises in both groups following strength guidelines.

Isotonic exercise then Plyometric exercise; Plyometric exercise then Isotonic exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 45 years of age
• Able to perform physical activity with their shoulder (moderate arm exercise for 15 min, such as tennis or housework)

You may not qualify if:

• Shoulder fracture
• Frozen shoulder (\>50% restriction in shoulder range of motion)
• Shoulder surgery
• Full rotator-cuff tears
• Bilateral shoulder pain
• Shoulder instability (history or positive apprehension test)
• Corticosteroid injection in the last 6 weeks
• Neurological diseases
• Cardiological diseases
• Systemic diseases (rheumatic diseases, autoimmune diseases)
• Uncontrolled diabetes
• Pregnancy
• Shoulder pain group: report unilateral shoulder pain with an average shoulder pain score of≥ 3 in the last week.
• Control group: report no shoulder pain within 6 months.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Ignacio A Raguzzi, PT

CONTACT

352-665-4947; iraguzzi@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The cross-over randomized clinical trial will have two exercise exposures (plyometric and isotonic). We will recruit individuals with and without shoulder pain. Both groups will perform each exercise exposure. In between the two exposures, each group will have a washout period of one week (± 3 days). Outcomes will be collected before each exercise exposure (baseline 1 and baseline 2), and after each exercise exposure (follow-up assessment 1 and 2). Each follow-up assessment involves data collection at three time points: 1 hour, 6 hours, and 24 hours after the exercise exposure.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol \& statistical analysis plan: A manuscript describing the study protocol and statistical analysis plan will be submitted for publication before the end of the recruitment for the study.
• Access Criteria: Study protocol and statistical analysis plan: The manuscript will be published as open access.

Locations

US (1)