Rotator Cuff DiseaseNCT07886827
Functional Electrical Stimulation Combined With Exercise for Rotator Cuff-Related Shoulder Pain in Older Adults
A study testing Functional electrical stimulation and Progressive Resistance Training in people with Rotator Cuff Disease and Subacromial Pain Syndrome, run by Lisa Griffin at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether adding functional electrical stimulation (FES) to a shoulder exercise program improves how the shoulder muscles work together in older adults with rotator cuff-related shoulder pain. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rotator Cuff Disease, Subacromial Pain Syndrome, Shoulder Pain
- What is being tested?
- Functional electrical stimulation and Progressive Resistance Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Sep 2029
- Phase
- Interventional
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having pain more than 2 weeks in the anterolateral shoulder region
- A painful arc of movement (60°-120°)
- Having shown positive impingement signs, including positive Neer, Hawkins, and Empty Can tests
Who cannot join
- Acute diagnosed rotator cuff tears
- Osteoarthritis-induced shoulder pain
- Currently receiving treatment or physical therapy for shoulder pain
- Previous shoulder surgery
- Taking medications that affect the central nervous system
- Metabolic or cardiovascular disease
Show all 9Show fewer
- Metal Implants or pacemakers
- Skin lesions on the shoulder
- Aversion to needles
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
The University of Texas at Austin, Austin, Texas, 78712
Austin, Texas, 78703
Ziwei Luo, M.Sc., 5125905388, ziweil@utexas.edu
Lisa Griffin, Ph.D., 5124712786, l.griffin@austin.utexas.edu
About this study
Official title: Functional Electrical Stimulation for Improving Shoulder Pain
The goal of this clinical trial is to learn whether adding functional electrical stimulation (FES) to a shoulder exercise program improves how the shoulder muscles work together in older adults with rotator cuff-related shoulder pain. FES uses small electrical currents delivered through pads on the skin to help muscles contract.
The main questions it aims to answer are:
Read more
- Does exercise combined with FES improve coordination between the rotator cuff and deltoid muscles more than exercise alone?
- Does exercise combined with FES increase the space between the top of the upper arm bone and the shoulder blade (acromiohumeral distance), which may reduce pinching of the shoulder tendons?
Researchers will compare a group that receives resistance exercise with FES to a group that receives the same resistance exercise without FES.
Participants will:
- Attend exercise sessions 3 times per week for 4 weeks (12 sessions)
- Complete 4 testing visits: before training, after 2 weeks, after 4 weeks, and 4 weeks after training ends
- At each testing visit, perform shoulder strength tasks while muscle activity is recorded with sensors on the skin and thin wire sensors placed in the muscle, have an ultrasound of the shoulder, and complete questionnaires about shoulder pain and function
Read the detailed description
Subacromial shoulder pain is common in older adults and is associated with rotator cuff disease. The rotator cuff muscles stabilize the humeral head against the upward pull of the deltoid during arm elevation. Previous work from our laboratory showed that intermuscular EMG-EMG coherence between rotator cuff muscles increases during fatigue in healthy individuals but not in individuals with subacromial pain, suggesting impaired common neural drive to these muscles. Functional electrical stimulation (FES) has been shown to increase corticospinal excitability and muscle activation, but its long-term effects on neuromuscular coordination of the shoulder have not been studied.
This randomized controlled trial evaluates whether a 4-week resistance training program combined with FES improves neuromuscular control of the supraspinatus, infraspinatus, and middle deltoid compared with the same training without FES. Neuromuscular control is assessed using surface and intramuscular (fine-wire) EMG during isometric shoulder abduction at 25%, 50%, and 75% of maximal voluntary contraction, during ramp contractions, and during a sustained fatiguing contraction. Acromiohumeral distance and supraspinatus tendon occupation ratio are measured with ultrasound at 0°, 45°, and 60° of shoulder abduction.
- Conditions
- Rotator Cuff Disease, Subacromial Pain Syndrome, Shoulder Pain, Subacromial Impingement Syndrome
- Being tested
- Functional electrical stimulation, Sham Functional Electrical Stimulation, Progressive Resistance Training
- Keywords
- Neuromuscular Electrical Stimulation, Functional Electrical Stimulation, Resistance Training, Older Adults, Eletromyography, Intermuscular Coherence, Acromiohumeral Distance, Shoulder Ultrasound Imaging, Shoulder Pain and Disability Index
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electrical stimulationDevice
Also called NEUBIE, FES, Pulsed Direct Current Electrical Stimulation
Pulsed direct current electrical stimulation delivered by the NEUBIE stimulator through surface electrodes placed over the supraspinatus and infraspinatus muscles during resistance exercises (40 Hz, 0.46 ms pulse width, maximum comfortable intensity).
Sham Functional Electrical StimulationDevice
Also called Sham FES
Identical electrode placement over the supraspinatus and infraspinatus and identical NEUBIE stimulator setup as the active FES intervention, applied during the same resistance exercises, with stimulator intensity set to 0 so that no electrical current is delivered.
Progressive Resistance TrainingBehavioural
A standardized 3-phase progressive resistance training program (Michener et al., 2024) using elastic resistance bands, performed 3 times per week for 4 weeks under supervision by research staff. Participants progress through phases based on performance and symptom tolerance.
| Study group | Role | What they receive |
|---|---|---|
| FES + Resistance Training | Experimental | Participants perform a standardized 3-phase progressive resistance training program 3 times per week for 4 weeks (12 sessions, 20-30 minutes each) while receiving functional electrical stimulation (NEUBIE stimulator) to the supraspinatus and infraspinatus muscles (40 Hz, 0.46 ms pulse width, maximum comfortable intensity). Receives: Device: Functional electrical stimulation; Behavioral: Progressive Resistance Training |
| Sham FES + Resistance Training | Sham comparator | Participants perform the same standardized 3-phase progressive resistance training program 3 times per week for 4 weeks (12 sessions, 20-30 minutes each). Stimulation electrodes are placed over the supraspinatus and infraspinatus muscles using the same setup procedure as the FES group, but the NEUBIE stimulator intensity is set to 0, so no electrical current is delivered. Receives: Device: Sham Functional Electrical Stimulation; Behavioral: Progressive Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermuscular EMG Coherence During Submaximal Isometric Contractions
EMG-EMG coherence between muscle pairs (supraspinatus-infraspinatus, supraspinatus-middle deltoid, infraspinatus-middle deltoid) recorded with surface and fine-wire electromyography during 30-second sustained isometric shoulder scaption at 25%, 50%, and 75% of maximal voluntary contraction. Coherence is quantified in the delta (2-5 Hz), alpha (5-15 Hz), and beta (15-35 Hz) frequency bands. Coherence values range from 0 (no shared neural drive) to 1 (complete shared neural drive).
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Intermuscular EMG Coherence During a Fatiguing Contraction
EMG-EMG coherence between muscle pairs (supraspinatus-infraspinatus, supraspinatus-middle deltoid, infraspinatus-middle deltoid) in the delta (2-5 Hz), alpha (5-15 Hz), and beta (15-35 Hz) frequency bands during a sustained isometric contraction at 25% of maximal voluntary contraction held until the endurance limit (force drop of 5% MVC). Values range from 0 (no shared neural drive) to 1 (complete shared neural drive).
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Secondary outcomes (7)
Acromiohumeral Distance
Shortest linear distance between the inferior edge of the acromion and the humeral head, measured with ultrasound at rest (0° abduction) and during active shoulder abduction at 50% MVC at 45° and 60°. Each value is the average of 3 measurements. Measured in centimeters.
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Supraspinatus Tendon Occupation Ratio
Ratio of supraspinatus tendon thickness to acromiohumeral distance, calculated as (tendon thickness / AHD) × 100, measured with ultrasound at 0°, 45°, and 60° of shoulder abduction. Each value is the average of 3 measurements. Expressed as a percentage.
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Shoulder Pain and Disability Index (SPADI)
Self-administered questionnaire assessing shoulder pain and difficulty with upper-extremity activities of daily living. Total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Muscle Fatigue Rate
Slope of the EMG median frequency over time for the supraspinatus, infraspinatus, and middle deltoid during the sustained fatiguing contraction, calculated from surface and fine-wire EMG. A steeper negative slope indicates faster fatigue.
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Muscle Onset Time During Ramp Contractions
Onset time of the supraspinatus, infraspinatus, and middle deltoid relative to force onset during isometric shoulder abduction ramp contractions (0 to 100% MVC at 7.5% MVC/s). Onset is defined as EMG amplitude exceeding 3 standard deviations of resting baseline for at least 25 ms. Measured in milliseconds.
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Motor Unit Recruitment Threshold
Force level at which individual motor units in the supraspinatus and middle deltoid are recruited during ramp contractions, identified from fine-wire EMG as the first of four consecutive spikes. Expressed as percentage of maximal voluntary contraction (% MVC).
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Motor Unit Initial Firing Rate
Firing rate of individual supraspinatus and middle deltoid motor units at recruitment during ramp contractions, calculated as the average of the first three inter-spike intervals. Measured in hertz (Hz).
Measured: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Oct 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: resistance training combined with functional electrical stimulation (FES group) or the same resistance training without FES (control group). Both groups train 3 times per week for 4 weeks and are tested at baseline, 2 weeks, 4 weeks (end of training), and 4 weeks after training ends.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisa Griffin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa Griffin, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886827
- Sponsor's protocol ID
- STUDY00007294
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No