Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06694402

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

Led by National Yang Ming Chiao Tung University · Updated on 2025-05-22

90

Participants Needed

1

Research Sites

51 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Anterior or lateral shoulder pain lasting 3 months or more
  • Aged 18 to 65 years old
  • Pain intensity of at least 3 out of 10 on the Pain-Numeric Scale
  • Diagnosed with subacromial impingement syndrome with at least 3 positive tests among Neer's, Hawkins-Kennedy, Empty can, Resisted external rotation, painful arc during arm elevation, or tenderness of rotator cuff tendons
Not Eligible

You will not qualify if you...

  • History of shoulder dislocation, fracture, adhesive capsulitis, or surgery
  • Presence of neck pain
  • Limited shoulder flexion or abduction less than 150 degrees
  • History of direct injury to neck or upper limbs within the past 12 months
  • Brain injury or neurological impairment
  • Pain caused by inflammatory conditions like rheumatoid arthritis
  • Psychosis or symptoms of headache or dizziness
  • Taking medications acting on the central nervous system
  • Contraindications to transcranial magnetic stimulation (TMS)
  • Received shoulder physical therapy or corticosteroid injections in past 3 months
  • Received high-concentration platelet-rich plasma injections in the shoulder joint in past year

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Yang Ming Chiao Tung University

Taipei, Taiwan, 112

Actively Recruiting

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Research Team

Y

Yin-Liang Lin, PhD

CONTACT

S

Szu-Yu Chiu, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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