National Yang Ming Chiao Tung University
Taipei, 112, Taiwan
NCT Number: NCT06694402
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Taipei, 112, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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
Exclusion criteria
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.
The control group will receive 30-minute exercise without focal muslce vibration.
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).
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).
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).
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)
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
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
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
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
Time frame: Change from baseline DASH scores at the completion of 12-session intervention, an average of 6 weeks
Subjects will be asked 30 items related to shoulder functional movement. The overall score ranges from 0 (no disability) to 100 (most severe disability).
Time frame: Change from baseline VAS scores at the completion of 12-session intervention, an average of 6 weeks
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).
Time frame: Change from baseline CES-D scores at the completion of 12-session intervention, an average of 6 weeks
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.
Time frame: Change from baseline PPT at the completion of 12-session intervention, an average of 6 weeks
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.
National Yang Ming Chiao Tung University
Other
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