Recruiting

FES & Exercise

Sponsor:

Lisa Griffin

Code:

NCT07886827

Conditions

Rotator Cuff Disease

Subacromial Pain Syndrome

Shoulder Pain

Subacromial Impingement Syndrome

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Functional electrical stimulation

Sham Functional Electrical Stimulation

Progressive Resistance Training

Study Details

Brief 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. FES uses small electrical currents delivered through pads on the skin to help muscles contract.

The main questions it aims to answer are:

1. Does exercise combined with FES improve coordination between the rotator cuff and deltoid muscles more than exercise alone?
2. 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:

1. Attend exercise sessions 3 times per week for 4 weeks (12 sessions)
2. Complete 4 testing visits: before training, after 2 weeks, after 4 weeks, and 4 weeks after training ends
3. 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

Conditions

Rotator Cuff Disease

Subacromial Pain Syndrome

Shoulder Pain

Subacromial Impingement Syndrome

Study ID

NCT07886827

Start date

Oct 1, 2025

Status verified date

Oct, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Metal Implants or pacemakers
  • Skin lesions on the shoulder
  • Aversion to needles

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FES + Resistance Training

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).

sham comparator: Sham FES + 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.

Interventions

Functional 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 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.

Progressive Resistance Training

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.

Primary outcome measure

  • Intermuscular EMG Coherence During Submaximal Isometric Contractions [ 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 [ Time Frame: Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention) ]

Central Contacts and Locations

Central contacts

Ziwei Luo, M.Sc.

5125905388ziweil@utexas.edu

Locations

The University of Texas at Austin, Austin, Texas, 78712

Recruiting

Austin, Texas, United States, 78703

Contacts

Ziwei Luo, M.Sc.

5125905388ziweil@utexas.edu

Lisa Griffin, Ph.D.

5124712786l.griffin@austin.utexas.edu

More Information

Sponsor

Lisa Griffin

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

  • Neuromuscular Electrical Stimulation
  • Functional Electrical Stimulation
  • Resistance Training
  • Older Adults
  • Eletromyography
  • Intermuscular Coherence
  • Acromiohumeral Distance
  • Shoulder Ultrasound Imaging
  • Shoulder Pain and Disability Index

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Lisa Griffin on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.