Focal VibrationNCT06694402
The Effects of Focal Muscle Vibration Combined With Exercise on Sensorimotor Activity in Individuals With Chronic Subacromial Impingement Syndrome
A study testing focal muscle vibration combined with exercise and exercise in people with Focal Vibration and Electroencephalography, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Background: Subacromial impingement syndrome (SIS) is a common shoulder disorder characterized by pain, altered movement patterns, and functional impairment. Forty-four to sixty-five percents of the patients with SIS would develop chronic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Vibration, Electroencephalography, Transcranial Magnetic Stimulation
- What is being tested?
- focal muscle vibration combined with exercise and exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jan 2025to 30 Apr 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior or lateral shoulder pain ≥ 3 months
- 18 to 65 years old
- The most pain intensity ≥ 3/10 Pain-Numeric Scale (NRS)
- SIS, at least 3 positive findings of the following tests:
- Neer's test (2) Hawkins-Kennedy test (3) Empty can test (4) Resisted external rotation test (5) Presenting painful arc during arm elevation (6) Tenderness of the rotator cuff tendons
Who cannot join
- History of dislocation, fracture, adhesive capsulitis or surgery of upper extremity
- Neck pain
- Shoulder flexion or abduction less than 150 degrees
- History of direct contact injury to the neck or upper extremities within the past 12 months
- Brain injury and neurological impairment
- Inflammatory cause of the pain (e.g., rheumatoid arthritis)
Show all 11Show fewer
- Psychosis and symptom of headache or dizziness
- Taking centrally acting medication
- Contraindications to the use of transcranial magnetic stimulation (TMS)
- Received shoulder-related physical therapy or corticosteroid injections in the past three months.
- Received high-concentration platelet-rich plasma (PRP) injections in the shoulder joint in the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Subacromial impingement syndrome (SIS) is a common shoulder disorder characterized by pain, altered movement patterns, and functional impairment. Forty-four to sixty-five percents of the patients with SIS would develop chronic symptoms. Chronic subacromial impingement syndrome (CSIS) is involved in the alteration of central nervous system, such as somatosensory dysfunction and corticomotor changes. The treatments for these patients usually focus on shoulder control and strengthening exercise but no treatment has been found to be targeted on the alterations in somatosensory dysfunction. Focal muscle vibration (FMV) is a useful tool to provide proprioceptive stimulation and has showed short-term effects of improving sensorimotor performance in both healthy and diseased individuals when combined with exercise. To our knowledge, no study has used FMV combined with shoulder exercise for individuals with shoulder problems.
Purpose: To investigate the effects of FMV combined with exercise on somatosensory activity, corticomotor excitability, pain and function in individuals with CSIS.
Read more
Methods: This is a randomized control trial. We will recruit ninety subjects with CSIS to receive a 12-session treatment protocol of FMV combined with shoulder exercises. The subjects will be randomized into a treatment group or control group. While the treatment group will receive 20-minute FMV when doing strength training, the control group will have the vibrators attached on but without being turned on during strength training. Both groups will have a 10-20 minutes of shoulder control training following the FMV protocol. The outcomes will be measured before and after the 12-session treatment protocol and include measures of somatosensory activity (using Electroencephalography, EEG), corticomotor excitability (using transcranial magnetic stimulation, TMS), pressure pain threshold, depression scale, pain intensity in a numerical rating scale, and shoulder function. The somatosensory measures include somatosensory-evoked potentials and event-related potentials during arm elevation. Corticomotor measures include motor evoked potentials, active and rest motor threshold and cortical silent period as well as intracortical inhibitory and facilitatory mechanisms. Shoulder function will be measured with the disabilities of the arm, shoulder and hand scale, the patient-specific functional scale, and the global rating of change scale.
Statistical analysis: The continuous and categorical variables of basic data will be analyzed by and independent t test and a Chi-square test, respectively. A two-way mixed ANOVA will be used to test between-group and within-group intervention effects. If there is a significant interaction effect, post hoc pairwise comparisons with Bonferroni correction will be used. The alpha level is set at 0.05.
- Conditions
- Focal Vibration, Electroencephalography, Transcranial Magnetic Stimulation, Somatosensory Dysfunction, Corticomotor Excitability, Intracortical Inhibition
- Being tested
- focal muscle vibration combined with exercise, exercise
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focal muscle vibration combined with exerciseDevice
The treatment group will receive a 30-minute intervention in each session. Focal muscle vibration will be applied to the anterior and lateral parts of shoulder to give a sensory stimulation while participants are doing eaercise.
exerciseOther
The control group will receive 30-minute exercise without focal muslce vibration.
| Study group | Role | What they receive |
|---|---|---|
| focal muscle vibration combined with exercise | Experimental | Not described Receives: Device: focal muscle vibration combined with exercise |
| exercise alone | Active comparator | Not described Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatosensory cortical activity - Somatosensory evoked potentials
Somatosensory evoked potentials (SEP) will be described with microvolt (µV) and millisecond (ms).
Measured: Change from baseline SEP at the completion of 12-session intervention, an average of 6 weeks
Corticomotor excitability measures - Active motor threshold
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Measured: Change from baseline AMT at the completion of 12-session intervention, an average of 6 weeks
Corticomotor excitability measures - Motor evoked potential
Motor evoked potential (MEP) will be described with millivolt (mV).
Measured: Change from baseline MEP at the completion of 12-session intervention, an average of 6 weeks
Corticomotor excitability measures - Cortical silent period
Cortical silent period (CSP) will be measured with millisecond (ms)
Measured: Change from baseline CSP at the completion of 12-session intervention, an average of 6 weeks
Corticomotor excitability measures - Short interval cortical inhibition
Short interval cortical inhibition (SICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms
Measured: Change from baseline SICI at the completion of 12-session intervention, an average of 6 weeks
Corticomotor excitability measures - Short interval cortical facilitation
Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Measured: Change from baseline SICF at the completion of 12-session intervention, an average of 6 weeks
Corticomotor excitability measures - Interval cortical facilitation
Interval cortical facilitation (ICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Measured: Change from baseline ICF at the completion of 12-session intervention, an average of 6 weeks
Corticomotor excitability measures - Long-interval intracortical inhibition
Long-interval intracortical inhibition (LICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms
Measured: Change from baseline LICI at the completion of 12-session intervention, an average of 6 weeks
Secondary outcomes (4)
Shoulder pain and function-Taiwan version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Subjects will be asked 30 items related to shoulder functional movement. The overall score ranges from 0 (no disability) to 100 (most severe disability).
Measured: Change from baseline DASH scores at the completion of 12-session intervention, an average of 6 weeks
Visual analogue scale (VAS) of shoulder pain
Shoulder pain and instability will be measured by visual analogue scale (VAS). Subjects need to mark the point that they feel represent their perception of their current state on a 10-cm line. Scores range from 0 (no symptom) to 100 (maximum symptom).
Measured: Change from baseline VAS scores at the completion of 12-session intervention, an average of 6 weeks
Depression- Taiwan version of the Center for Epidemiologic Studies Depression Scale (CES-D)
Subjects will be asked 20 items to rate how often over the past week they experienced symptoms associated with depression. Response options range from 0 to 3 for each item. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: Change from baseline CES-D scores at the completion of 12-session intervention, an average of 6 weeks
Pressure pain thresholds
Pressure pain threshold (PPT) of bilateral upper trapezius, levator scapulae, infraspinatus, pectoralis major, biceps brachii, middle deltoid and tibialis anterior will each be averaged and will be described with kg/cm2.
Measured: Change from baseline PPT at the completion of 12-session intervention, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start8 Jan 2025
- Primary completion30 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal VibrationStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin-Liang Lin, National Yang Ming Chiao Tung University
- Investigators
- Yin-Liang Lin, PhD, Principal investigator, National Yang Ming Chaio Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694402
- Sponsor's protocol ID
- NYCU113082AF
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Focal Muscle Vibration Combined With Exercise on Sensorimotor Activity in Individuals With Chronic Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06694402
- Acronym / sponsor ID
- NYCU113082AF
- Conditions
- Focal Vibration, Electroencephalography, Transcranial Magnetic Stimulation, Somatosensory Dysfunction, Corticomotor Excitability, Intracortical Inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 19 Nov 2024 (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.
Background: Subacromial impingement syndrome (SIS) is a common shoulder disorder characterized by pain, altered movement patterns, and functional impairment. Forty-four to sixty-five percents of the patients with SIS would develop chronic symptoms. Chronic subacromial impingement syndrome (CSIS) is involved in the alteration of central nervous system, such as somatosensory dysfunction and corticomotor changes. The treatments for these patients usually focus on shoulder control and strengthening exercise but no treatment has been found to be targeted on the alterations in somatosensory dysfunction. Focal muscle vibration (FMV) is a useful tool to provide proprioceptive stimulation and has showed short-term effects of improving sensorimotor performance in both healthy and diseased individuals when combined with exercise. To our knowledge, no study has used FMV combined with shoulder exercise for individuals with shoulder problems.
Purpose: To investigate the effects of FMV combined with exercise on somatosensory activity, corticomotor excitability, pain and function in individuals with CSIS.
Methods: This is a randomized control trial. We will recruit ninety subjects with CSIS to receive a 12-session treatment protocol of FMV combined with shoulder exercises. The subjects will be randomized into a treatment group or control group. While the treatment group will receive 20-minute FMV when doing strength training, the control group will have the vibrators attached on but without being turned on during strength training. Both groups will have a 10-20 minutes of shoulder control training following the FMV protocol. The outcomes will be measured before and after the 12-session treatment protocol and include measures of somatosensory activity (using Electroencephalography, EEG), corticomotor excitability (using transcranial magnetic stimulation, TMS), pressure pain threshold, depression scale, pain intensity in a numerical rating scale, and shoulder function. The somatosensory measures include somatosensory-evoked potentials and event-related potentials during arm elevation. Corticomotor measures include motor evoked potentials, active and rest motor threshold and cortical silent period as well as intracortical inhibitory and facilitatory mechanisms. Shoulder function will be measured with the disabilities of the arm, shoulder and hand scale, the patient-specific functional scale, and the global rating of change scale.
Statistical analysis: The continuous and categorical variables of basic data will be analyzed by and independent t test and a Chi-square test, respectively. A two-way mixed ANOVA will be used to test between-group and within-group intervention effects. If there is a significant interaction effect, post hoc pairwise comparisons with Bonferroni correction will be used. The alpha level is set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| focal muscle vibration combined with exercise | Experimental | Device: focal muscle vibration combined with exercise |
| exercise alone | Active comparator | Other: exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Anterior or lateral shoulder pain ≥ 3 months
- 18 to 65 years old
- The most pain intensity ≥ 3/10 Pain-Numeric Scale (NRS)
- SIS, at least 3 positive findings of the following tests:
- Neer's test (2) Hawkins-Kennedy test (3) Empty can test (4) Resisted external rotation test (5) Presenting painful arc during arm elevation (6) Tenderness of the rotator cuff tendons
Key exclusion criteria (11 listed)
- History of dislocation, fracture, adhesive capsulitis or surgery of upper extremity
- Neck pain
- Shoulder flexion or abduction less than 150 degrees
- History of direct contact injury to the neck or upper extremities within the past 12 months
- Brain injury and neurological impairment
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 |
|---|---|---|
| focal muscle vibration combined with exerciseThe treatment group will receive a 30-minute intervention in each session. Focal muscle vibration will be applied to the anterior and lateral parts of shoulder to give a sensory stimulation while participants are doing eaercise. | Device | focal muscle vibration combined with exercise |
| exerciseThe control group will receive 30-minute exercise without focal muslce vibration. | Other | exercise alone |
Primary outcome
Somatosensory cortical activity - Somatosensory evoked potentials
Time frame: Change from baseline SEP at the completion of 12-session intervention, an average of 6 weeks
Somatosensory evoked potentials (SEP) will be described with microvolt (µV) and millisecond (ms).
Corticomotor excitability measures - Active motor threshold
Time frame: Change from baseline AMT at the completion of 12-session intervention, an average of 6 weeks
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Corticomotor excitability measures - Motor evoked potential
Time frame: Change from baseline MEP at the completion of 12-session intervention, an average of 6 weeks
Motor evoked potential (MEP) will be described with millivolt (mV).
Corticomotor excitability measures - Cortical silent period
Time frame: Change from baseline CSP at the completion of 12-session intervention, an average of 6 weeks
Cortical silent period (CSP) will be measured with millisecond (ms)
Corticomotor excitability measures - Short interval cortical inhibition
Time frame: Change from baseline SICI at the completion of 12-session intervention, an average of 6 weeks
Short interval cortical inhibition (SICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms
Corticomotor excitability measures - Short interval cortical facilitation
Time frame: Change from baseline SICF at the completion of 12-session intervention, an average of 6 weeks
Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Corticomotor excitability measures - Interval cortical facilitation
Time frame: Change from baseline ICF at the completion of 12-session intervention, an average of 6 weeks
Interval cortical facilitation (ICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Corticomotor excitability measures - Long-interval intracortical inhibition
Time frame: Change from baseline LICI at the completion of 12-session intervention, an average of 6 weeks
Long-interval intracortical inhibition (LICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms
4 secondary outcomes
Shoulder pain and function-Taiwan version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Change from baseline DASH scores at the completion of 12-session intervention, an average of 6 weeks
Visual analogue scale (VAS) of shoulder pain
Time frame: Change from baseline VAS scores at the completion of 12-session intervention, an average of 6 weeks
Depression- Taiwan version of the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Change from baseline CES-D scores at the completion of 12-session intervention, an average of 6 weeks
Pressure pain thresholds
Time frame: Change from baseline PPT at the completion of 12-session intervention, an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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.
Yin-Liang Lin, PhD principal investigator
National Yang Ming Chaio Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focal muscle vibration combined with exercise and exercise in people with Focal Vibration and Electroencephalography, run by National Yang Ming Chiao Tung University 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 29 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory cortical activity - Somatosensory evoked potentials (time frame: Change from baseline SEP at the completion of 12-session intervention, an average of 6 weeks). The study lists 8 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 29 Jun 2026.