The Effects of Focal Muscle Vibration Combined With Exercise on Sensorimotor Activity in Individuals With Chronic Subacromial Impingement Syndrome

NCT06694402 | Recruiting

• 1 other identifier: NYCU113082AF
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Focal Vibration; Electroencephalography; Transcranial Magnetic Stimulation; Somatosensory Dysfunction; Corticomotor Excitability; Intracortical Inhibition; Chronic Subacromial Impingement Syndrome; Chronic Pain

Outcome Measures

Primary Outcomes (8)

• Somatosensory cortical activity - Somatosensory evoked potentials

  Somatosensory evoked potentials (SEP) will be described with microvolt (µV) and millisecond (ms).

  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).

  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).

  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)

  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

  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

  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

  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

  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

  Change from baseline DASH scores at the completion of 12-session intervention, an average of 6 weeks

• Visual analogue scale (VAS) of shoulder pain

  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)

  Change from baseline CES-D scores at the completion of 12-session intervention, an average of 6 weeks

• Pressure pain thresholds

  Change from baseline PPT at the completion of 12-session intervention, an average of 6 weeks

Study Arms (2)

focal muscle vibration combined with exercise

EXPERIMENTAL

Device: focal muscle vibration combined with exercise

exercise alone

ACTIVE COMPARATOR

Other: exercise

Interventions

focal muscle vibration combined with exercise DEVICE

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.

focal muscle vibration combined with exercise

exercise OTHER

The control group will receive 30-minute exercise without focal muslce vibration.

exercise alone

Eligibility Criteria

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

You may qualify if:

• Anterior or lateral shoulder pain ≥ 3 months
• to 65 years old
• The most pain intensity ≥ 3/10 Pain-Numeric Scale (NRS)
• SIS, at least 3 positive findings of the following tests:
• (1) 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise Therapy; Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yin-Liang Lin, PhD

  National Yang Ming Chaio Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yin-Liang Lin, PhD

CONTACT

+886-2-2826-7288; yllin1020@nycu.edu.tw

Szu-Yu Chiu, BS

CONTACT

sychiu.be12@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 8, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

TW (1)