Shoulder PainNCT07489937
Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.
A study testing Isotonic exercise program and Plyometric exercise program in people with Shoulder Pain and Healthy Adult, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Healthy Adult
- What is being tested?
- Isotonic exercise program and Plyometric exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Federico Pozzi, PT, MA, PhD, 352-273-6957, fpozzi@phhp.ufl.edu
Ignacio A Raguzzi, PT
About this study
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
- Being tested
- Isotonic exercise program, Plyometric exercise program
- Keywords
- rotator cuff related shoulder pain, rotator cuff tendinopathy, shoulder pain, tendon thickness, exercise, subacromial pain, ultrasound
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic exercise programBehavioural
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 programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Isotonic exercise then Plyometric exercise | Experimental | Not described Receives: Behavioral: Isotonic exercise program; Behavioral: Plyometric exercise program |
| Plyometric exercise then Isotonic exercise | Experimental | Not described Receives: Behavioral: Isotonic exercise program; Behavioral: Plyometric exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.
Secondary outcomes (2)
Pain sensitivity testing
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.
Measured: From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.
Self-reported pain
We will use an 11-point numeric pain rating scale to measure the shoulder pain perceived by the participant.
Measured: From enrollment to 1, 6, and 24 hours after each exercise program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489937
- Sponsor's protocol ID
- IRB202501875
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.
- ClinicalTrials.gov ID
- NCT07489937
- Acronym / sponsor ID
- IRB202501875
- Conditions
- Shoulder Pain, Healthy Adult
- Keywords
- rotator cuff related shoulder pain, rotator cuff tendinopathy, shoulder pain, tendon thickness, exercise, subacromial pain, ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isotonic exercise programParticipants 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. | Behavioural | Isotonic exercise then Plyometric exercise, Plyometric exercise then Isotonic exercise |
| Plyometric exercise programParticipants 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. | Behavioural | Isotonic exercise then Plyometric exercise, Plyometric exercise then Isotonic exercise |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotonic exercise program and Plyometric exercise program in people with Shoulder Pain and Healthy Adult, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio A Raguzzi, PT (352-665-4947, iraguzzi@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supraspinatus tendon thickness (time frame: From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.