An interventional study of Functional electrical stimulation and Sham Functional Electrical Stimulation in Rotator Cuff Disease, Subacromial Pain Syndrome and Shoulder Pain, sponsored by Lisa Griffin. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Lisa Griffin · Not applicable, Interventional, and Treatment
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:
Researchers will compare a group that receives resistance exercise with FES to a group that receives the same resistance exercise without FES.
Participants will:
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.
724 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 577 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Lisa Griffin is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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).
Device: Functional electrical stimulation · Behavioral: Progressive Resistance Training
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.
Device: Sham Functional Electrical Stimulation · Behavioral: Progressive Resistance Training
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).
Also known as: NEUBIE, FES, Pulsed Direct Current Electrical Stimulation
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.
Also known as: Sham FES
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.
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).
Time frame: 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).
Time frame: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)
Plan to share: No
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Started Oct 2025 (actual). Primary completion is estimated for Sep 2028, 35 months after the start.
Of 327 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 35 months is above that.
Counting every sponsor, half of 336 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Lisa Griffin