Reverse Shoulder ReplacementNCT06873022
EMG Biofeedback and NMES of Deltoid in Patients With rTSA
A study testing neuromuscular electrical stimulation and biofeedback in people with Reverse Shoulder Replacement, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics and muscle activation in individual post rTSA Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Reverse Shoulder Replacement
- What is being tested?
- neuromuscular electrical stimulation and biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2025to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) age between 20 to 85 years old
- (2) undergoing primary reverse shoulder arthroplasty
- (3) shoulder abduction in scapular plane above 90 degrees
- (4) above 3 months following rTSA
Who cannot join
- (1) a history of other shoulder surgery on the rTSA shoulder
- (2) a revision rTSA
- (3) a surgery shoulder muscle tendon transfer
- (4) neuromuscular diseases
- (5) cognitive disorders
- (6) contraindications for NMES
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University of school and graduate of physical therapy of Performance Analysis Laboratory
Taipei, Zhongzheng Dist., 100
YANG-TING CHIEN, +886980602820, yangting890218@gmail.com
About this study
Official title: Electromyography Biofeedback and Neuromuscular Electrical Stimulation of Deltoid in Patients With Reverse Total Shoulder Arthroplasty
The effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics and muscle activation in individual post rTSA
Read the detailed description
Reverse total shoulder arthroplasty (rTSA) has been the optimal treatment for massive irreparable rotator cuff tears and cuff tear arthropathy. Since scapular kinematics alteration was associated with shoulder disorders, scapular kinematics had been characterized in individuals post rTSA with more upward rotation, external rotation, and posterior tilt of the scapula. In addition, the average scapulohumeral rhythm ranged from 1.1 to 1.6, indicating lower glenohumeral joint movements and higher scapulothoracic movements. It supposed that more scapula upward rotation without adequate humeral elevation can result in the scapula notching. Therefore, strategy to decrease scapular movement or increase humeral movements during arm movements may prevent scapula notching. To compensate for rotator cuff deficiency, the deltoid muscle plays a crucial role post rTSA. Enhancing deltoid function can be accomplished through the use of biofeedback or neuromuscular electrical stimulation (NMES). However, the effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics, muscle activation, and muscle balance ratio in individual post rTSA remained unclear. Therefore, the objectives in this study would to (1) determine the immediate effects of NMES with EMG biofeedback to deltoid (D) on the muscle activation of upper trapezius (UT), lower Trapezius (LT) and serratus Anterior (SA) as well as the scapular kinematics (upward/downward rotation, external/internal rotation, anterior/posterior tilting) (2) evaluate the immediate effects of NMES with EMG biofeedback on the muscle balance ratios (D/UT, D/LT, D/SA) and the scapulohumeral rhythm (SHR) during arm elevation in the scapular plane at different range of motion.
- Conditions
- Reverse Shoulder Replacement
- Being tested
- neuromuscular electrical stimulation, biofeedback
- Keywords
- reverse total shoulder arthroplasty, neuromuscular electrical stimulation, surface electromyography, biofeedback, scapulohumeral rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulationDevice
NMES: Two electrode pads were placed on the anterior, middle, and posterior deltoid boundary lines and at a distance of 1cm distal to the lateral margin of the acromion. The operator palpated the deltoid muscle contraction and asked the subjects to perform arm elevation task with NMES. (frequency of 35 Hz and a duration of 250 microseconds.) A verbal cue was given during both th
A verbal cue was given during both the sEMG biofeedback and NMES interventions: "Lengthen your arm as if you want to touch the ground, the scapula keeps in the neutral position, and then elevate your arm." Each intervention consisted of 3 sets of 10 repetitions per set, with a 1-minute rest between sets.
biofeedbackDevice
sEMG biofeedback: Subjects were instructed to monitor the sEMG signals of the D/UT balances ratio on the screen and maintain the D/UT balances ratio above the threshold during arm elevation and lowering. The threshold was set at 1 standard deviation of the ratio average at baseline (before intervention).
| Study group | Role | What they receive |
|---|---|---|
| biofeedback | Experimental | sEMG biofeedback: Subjects were instructed to monitor the sEMG signals of the D/UT balances ratio on the screen and maintain the D/UT balances ratio above the threshold during arm elevation and lowering. The threshold was set at 1 standard deviation of the ratio average at baseline (before intervention). Receives: Device: biofeedback |
| neuromuscular electrical stimulation | Experimental | NMES: Two electrode pads were placed on the anterior, middle, and posterior deltoid boundary lines and at a distance of 1cm distal to the lateral margin of the acromion. The operator palpated the deltoid muscle contraction and asked the subjects to perform arm elevation task with NMES. (frequency of 35 Hz and a duration of 250 microseconds.) A verbal cue was given during both th A verbal cue was given during both the sEMG biofeedback and NMES interventions: "Lengthen your arm as if you want to touch the ground, the scapula keeps in the neutral position, and then elevate your arm." Each intervention consisted of 3 sets of 10 repetitions per set, with a 1-minute rest between sets. Receives: Device: neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activation
Muscle activation The muscle activation of upper trapezius, lower trapezius, serrates anterior, and deltoid were collected during arm elevation task by sEMG at baseline, post- sEMG biofeedback, and post- NMES. Muscle activation was analyzed based on 0°-30°, 30°-60°, and 60°-90° during arm elevation and lowering. The sEMG data was calculated using the root mean square (RMS) based on average of middle three from five trials. The MVIC of UT, LT, SA, and D were used to normalize the sEMG data.
Measured: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Scapular kinematics
Scapular kinematics The scapular kinematics during arm elevation task was captured using an electromagnetic motion analysis system. The three scapula orientations were described using the Euler angle sequence with an X-axis for scapular posterior/anterior tilt, Y-axis for scapular upward/downward rotation, and Z-axis for scapular internal/external rotation. The average of middle three from five trials on scapular kinematics were analyzed at 30°, 60°, and 90° arm elevation and lowering.
Measured: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Secondary outcomes (2)
Muscle balance ratios
Muscle balance ratios The muscle balance ratios of D/UT, D/LT, and D/SA were calculated based on average of middle three from five trials at the phases of 0°-30°, 30°-60°, and 60°-90° during arm elevation and lowering phase.
Measured: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Scapulohumeral rhythm
Scapulohumeral rhythm The scapulohumeral rhythm data was collected by humeral elevation relative to scapular upward rotation at the phases of 30°, 60°, and 90° arm elevation and lowering in scapular plane. The data was based on average of middle three from five trials.
Measured: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Shoulder ReplacementStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiu-Jenq Lin, Ph.D, Study chair, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873022
- Sponsor's protocol ID
- 202403141DINE
- Status last verified
- May 2024
- First submitted
- 17 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyography Biofeedback and Neuromuscular Electrical Stimulation of Deltoid in Patients With Reverse Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06873022
- Acronym / sponsor ID
- 202403141DINE
- Conditions
- Reverse Shoulder Replacement
- Keywords
- reverse total shoulder arthroplasty, neuromuscular electrical stimulation, surface electromyography, biofeedback, scapulohumeral rhythm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics and muscle activation in individual post rTSA
Detailed description
Reverse total shoulder arthroplasty (rTSA) has been the optimal treatment for massive irreparable rotator cuff tears and cuff tear arthropathy. Since scapular kinematics alteration was associated with shoulder disorders, scapular kinematics had been characterized in individuals post rTSA with more upward rotation, external rotation, and posterior tilt of the scapula. In addition, the average scapulohumeral rhythm ranged from 1.1 to 1.6, indicating lower glenohumeral joint movements and higher scapulothoracic movements. It supposed that more scapula upward rotation without adequate humeral elevation can result in the scapula notching. Therefore, strategy to decrease scapular movement or increase humeral movements during arm movements may prevent scapula notching. To compensate for rotator cuff deficiency, the deltoid muscle plays a crucial role post rTSA. Enhancing deltoid function can be accomplished through the use of biofeedback or neuromuscular electrical stimulation (NMES). However, the effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics, muscle activation, and muscle balance ratio in individual post rTSA remained unclear. Therefore, the objectives in this study would to (1) determine the immediate effects of NMES with EMG biofeedback to deltoid (D) on the muscle activation of upper trapezius (UT), lower Trapezius (LT) and serratus Anterior (SA) as well as the scapular kinematics (upward/downward rotation, external/internal rotation, anterior/posterior tilting) (2) evaluate the immediate effects of NMES with EMG biofeedback on the muscle balance ratios (D/UT, D/LT, D/SA) and the scapulohumeral rhythm (SHR) during arm elevation in the scapular plane at different range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofeedback | Experimental | Device: biofeedbacksEMG biofeedback: Subjects were instructed to monitor the sEMG signals of the D/UT balances ratio on the screen and maintain the D/UT balances ratio above the threshold during arm elevation and lowering. The threshold was set at 1 standard deviation of the ratio average at baseline (before intervention). |
| neuromuscular electrical stimulation | Experimental | Device: neuromuscular electrical stimulationNMES: Two electrode pads were placed on the anterior, middle, and posterior deltoid boundary lines and at a distance of 1cm distal to the lateral margin of the acromion. The operator palpated the deltoid muscle contraction and asked the subjects to perform arm elevation task with NMES. (frequency of 35 Hz and a duration of 250 microseconds.) A verbal cue was given during both th A verbal cue was given during both the sEMG biofeedback and NMES interventions: "Lengthen your arm as if you want to touch the ground, the scapula keeps in the neutral position, and then elevate your arm." Each intervention consisted of 3 sets of 10 repetitions per set, with a 1-minute rest between sets. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) age between 20 to 85 years old
- (2) undergoing primary reverse shoulder arthroplasty
- (3) shoulder abduction in scapular plane above 90 degrees
- (4) above 3 months following rTSA
Key exclusion criteria (6 listed)
- (1) a history of other shoulder surgery on the rTSA shoulder
- (2) a revision rTSA
- (3) a surgery shoulder muscle tendon transfer
- (4) neuromuscular diseases
- (5) cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular electrical stimulationNMES: Two electrode pads were placed on the anterior, middle, and posterior deltoid boundary lines and at a distance of 1cm distal to the lateral margin of the acromion. The operator palpated the deltoid muscle contraction and asked the subjects to perform arm elevation task with NMES. (frequency of 35 Hz and a duration of 250 microseconds.) A verbal cue was given during both th A verbal cue was given during both the sEMG biofeedback and NMES interventions: "Lengthen your arm as if you want to touch the ground, the scapula keeps in the neutral position, and then elevate your arm." Each intervention consisted of 3 sets of 10 repetitions per set, with a 1-minute rest between sets. | Device | neuromuscular electrical stimulation |
| biofeedbacksEMG biofeedback: Subjects were instructed to monitor the sEMG signals of the D/UT balances ratio on the screen and maintain the D/UT balances ratio above the threshold during arm elevation and lowering. The threshold was set at 1 standard deviation of the ratio average at baseline (before intervention). | Device | biofeedback |
Primary outcome
Muscle activation
Time frame: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Muscle activation The muscle activation of upper trapezius, lower trapezius, serrates anterior, and deltoid were collected during arm elevation task by sEMG at baseline, post- sEMG biofeedback, and post- NMES. Muscle activation was analyzed based on 0°-30°, 30°-60°, and 60°-90° during arm elevation and lowering. The sEMG data was calculated using the root mean square (RMS) based on average of middle three from five trials. The MVIC of UT, LT, SA, and D were used to normalize the sEMG data.
Scapular kinematics
Time frame: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Scapular kinematics The scapular kinematics during arm elevation task was captured using an electromagnetic motion analysis system. The three scapula orientations were described using the Euler angle sequence with an X-axis for scapular posterior/anterior tilt, Y-axis for scapular upward/downward rotation, and Z-axis for scapular internal/external rotation. The average of middle three from five trials on scapular kinematics were analyzed at 30°, 60°, and 90° arm elevation and lowering.
2 secondary outcomes
Muscle balance ratios
Time frame: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Scapulohumeral rhythm
Time frame: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiu-Jenq Lin, Ph.D study chair
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation and biofeedback in people with Reverse Shoulder Replacement, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YANG-TING CHIEN (+886980602820, yangting890218@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activation (time frame: before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.