Functional Electrical Stimulation Combined With Exercise for Rotator Cuff-Related Shoulder Pain in Older Adults

NCT07886827 | Recruiting FDA Device

• 1 other identifier: STUDY00007294
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Does exercise combined with FES improve coordination between the rotator cuff and deltoid muscles more than exercise alone?
2. 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?
3. 3.Attend exercise sessions 3 times per week for 4 weeks (12 sessions)
4. 4.Complete 4 testing visits: before training, after 2 weeks, after 4 weeks, and 4 weeks after training ends
5. 5.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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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

  Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)

• Supraspinatus Tendon Occupation Ratio

  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)

  Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)

• Muscle Fatigue Rate

  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

  Baseline, 2 weeks (mid-intervention), 4 weeks (end of intervention), and 8 weeks (4 weeks after the end of intervention)

Study Arms (2)

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).

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.

Device: Sham Functional Electrical Stimulation; Behavioral: Progressive Resistance Training

Interventions

Functional electrical stimulation DEVICE

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

FES + Resistance Training

Sham Functional Electrical Stimulation DEVICE

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

Sham FES + Resistance Training

Progressive Resistance Training BEHAVIORAL

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.

FES + Resistance Training; Sham FES + Resistance Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisa Griffin: lead

Study Sites (1)

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

Austin, Texas, 78703, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Central Study Contacts

Ziwei Luo, M.Sc.

CONTACT

5125905388; ziweil@utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the control group undergo the identical setup procedure, including placement of stimulation electrodes over the supraspinatus and infraspinatus, but the stimulator intensity is set to 0. Because the FES group receives perceptible stimulation, participant masking may be incomplete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)