Menu
Recruiting NCT07489937

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

No phase Interventional Shoulder Pain Healthy Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isotonic exercise program, Plyometric exercise program.
Who it may be relevant to
Registry conditions: Shoulder Pain, Healthy Adult. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Isotonic exercise program
    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 n
  • Behavioral Plyometric exercise program
    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 num

Primary outcome measures

  • Supraspinatus tendon thickness [Time frame: From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.]
Secondary outcome measures (2)
  • Pain sensitivity testing [Time frame: From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.]
  • Self-reported pain [Time frame: From enrollment to 1, 6, and 24 hours after each exercise program.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Florida — Gainesville

Identifiers

NCT: NCT07489937 · IRB202501875

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗