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NCT Number: NCT07489937

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

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.

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Key information

Conditions

Shoulder Pain Arthralgia Behavior Healthy Adult Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Federico Pozzi, PT, MA, PhD

CONTACT

[email protected]

352-273-6957

Ignacio A Raguzzi, PT

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

General inclusion criteria

  • 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)

General exclusion criteria

  • 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

Group-specific inclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Supraspinatus tendon thickness

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

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

Secondary outcomes

  1. Pain sensitivity testing

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

    The investigators will apply pressure at a constant rate using a computerized pressure algometer with a 1 cm diameter rubber tip at the shoulder and the lower limb.

  2. Self-reported pain

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

    We will use an 11-point numeric pain rating scale to measure the shoulder pain perceived by the participant.

Other outcomes

  1. Rate of perceived exertion

    Time frame: Immediately after each exercise program.

    We will use a 11-point scale, 0 being no effort and 10 being the maximal effort, to understand the effort perceived after each exercise program.

  2. Pennsylvania Shoulder Score (PENN)

    Time frame: At baseline before each exercise program.

    The PENN is a valid and reliable self-reported questionnaire for patients with shoulder pain.

  3. Optimal Screening for Prediction of Referral and Outcome (OSPRO)

    Time frame: At baseline before the first exercise program.

    The OSPRO is a concise, multidimensional 10-item yellow flag assessment tool that estimates 11 total questionnaire scores indicating elevated vulnerability and decreased resilience.

  4. Global rating of change (GROC)

    Time frame: At the second baseline before the second exercise program at 1 week.

    The GROC is a rating scale that quantifies participants' improvement or deterioration of symptoms over time. Changes will be measured using a 15-points Likert scale (-7, a very great deal worse to 7, a very great deal better, with 0 indicating no changes).

  5. Tegner Activity Scale

    Time frame: At baseline before the first exercise program.

    Is a valid and reliable tool that evaluates work and sport participation. It addresses both function and activity level, and it will provide information about the physical general activity of the individual.

  6. Rate of perceived fatigue

    Time frame: Immediately after each exercise program

    We will use a 11-point scale, 0 being no fatigue and 10 being the maximal fatigue, to understand the fatigue perceived after each exercise program.

  7. Self-reported pain related to the exercise

    Time frame: Before and immediately after each exercise program

    We will use an 11-point numeric pain rating scale to measure the shoulder pain perceived by the participant.

  8. Muscle soreness

    Time frame: Before and immediately, 1, 6 and 24 hours after each exercise program

    We will use an 11-point numeric rating scale to measure the muscle soreness perceived by the participant after the exercise.

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio A Raguzzi, PT

CONTACT

[email protected]

352-665-4947

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Apr 22, 2026

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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