Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Florida
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to perform physical activity with their shoulder (moderate arm exercise for 15 min, such as tennis or housework)
Disqualifiers
Shoulder fracture
Frozen shoulder (>50% restriction in shoulder range of motion)
Shoulder surgery
Full rotator-cuff tears
Trial design
Design model
Crossover
Treatments tested in this trial
Isotonic exercise program
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Isotonic exercise then Plyometric exerciseExperimental treatment 2 interventions
Group B: Plyometric exercise then Isotonic exerciseExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.Secondary outcomes
1
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.
Time frame
From enrollment to 1 hour, 6 hours, and 24 hours after each exercise program.2
Self-reported pain
We will use an 11-point numeric pain rating scale to measure the shoulder pain perceived by the participant.
Time frame
From enrollment to 1, 6, and 24 hours after each exercise program.Other outcomes
1
Rate of perceived exertion
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.
Time frame
Immediately after each exercise program.2
Pennsylvania Shoulder Score (PENN)
The PENN is a valid and reliable self-reported questionnaire for patients with shoulder pain.
Time frame
At baseline before each exercise program.3
Optimal Screening for Prediction of Referral and Outcome (OSPRO)
The OSPRO is a concise, multidimensional 10-item yellow flag assessment tool that estimates 11 total questionnaire scores indicating elevated vulnerability and decreased resilience.
Time frame
At baseline before the first exercise program.4
Global rating of change (GROC)
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).
Time frame
At the second baseline before the second exercise program at 1 week.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov