The Effects of Focal Muscle Vibration Combined With Exercise on Sensorimotor Activity in Individuals With Chronic Subacromial Impingement Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Somatosensory cortical activity - Somatosensory evoked potentials
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •(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
排除标准
- •History of dislocation, fracture, adhesive capsulitis or surgery of upper extremity
- •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.
研究组 & 干预措施
focal muscle vibration combined with exercise
干预措施: focal muscle vibration combined with exercise (Device)
exercise alone
干预措施: exercise (Other)
结局指标
主要结局
Somatosensory cortical activity - Somatosensory evoked potentials
时间窗: 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
时间窗: 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 - Short interval cortical inhibition
时间窗: 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 - Motor evoked potential
时间窗: 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
时间窗: 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 facilitation
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
- 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)
研究者
Yin-Liang Lin
Associate Professor
National Yang Ming Chiao Tung University