Electric Dry Needling and Spinal Manipulation vs. Impairment-based Mobilization, Exercise and Interferential Electrotherapy for Patients With Shoulder Impingement (Subacromial Pain Syndrome): a Multi-center Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Change in Shoulder Pain and Disability Index
研究概览
简要总结
The purpose of this research is to compare two different approaches for treating patients with shoulder impingement (subacromial pain syndrome): electric dry needling and spinal manipulation versus impairment-based mobilization, exercise, and interferential electrotherapy. Physical therapists commonly use all of these techniques to treat shoulder impingement (subacromial pain syndrome). This study is attempting to find out if one treatment strategy is more effective than the other.
详细描述
Patients with shoulder impingement (subacromial pain syndrome) will be randomized to receive 2 treatment sessions per week for up to 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and spinal manipulation or (2) impairment-based mobilization, exercise and interferential electrotherapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult over the age of 18 years old that is able to read, write and speak English
- •Primary complaint of anterolateral shoulder pain lasting longer than 6 weeks
- •One or more of the following special tests:
- •Positive Neer Impingement test-i.e. pain with passive overpressure at full shoulder flexion with the scapula stabilized.
- •Positive Hawkins-Kennedy test-i.e. pain with passive internal rotation at 90° of shoulder and elbow flexion
- •Pain with ONE or more of the following active movements and resisted isometric tests
- •Pain with active shoulder elevation
- •Pain with resisted shoulder external rotation at 90 deg of abduction
- •Pain with resisted shoulder abduction in Empty Can Test positon - i.e. 90 deg of shoulder abduction, 30 deg of horizontal adduction (i.e. in scapular plane) and full internal rotation (i.e. thumb down)
排除标准
- •Report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- •History of shoulder injection within the past 3 months.
- •History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, or cervical, thoracic or shoulder surgery.
- •Isolated acromioclavicular joint pathology (i.e. the only location of symptoms is localized specifically with one finger directly over the acromioclavicular joint and nowhere else, and reproduced only with acromioclavicular palpation by the examiner.)
- •Evidence of cervical radiculopathy, radiculitis or referred pain from the c-spine
- •Full-thickness rotator cuff tears (evidenced by MRI and/or positive lag signs)
- •Baseline SPADI of not less than 20%
- •History of breast cancer on involved side.
- •Prior treatments (eg. Acupuncture, physical therapy, chiropractic, dry needling, massage therapy, injections) to the involved limb over past 3 months.
- •Pending litigation for an injury.
- •Psychiatric disorders or cognitively impaired
研究组 & 干预措施
mobilization, exercise, modalities
干预措施: exercise (Other)
dry needling and spinal manipulation
干预措施: dry needling (Other)
dry needling and spinal manipulation
干预措施: spinal manipulation (Other)
mobilization, exercise, modalities
干预措施: mobilization (Other)
mobilization, exercise, modalities
干预措施: modalities (Other)
结局指标
主要结局
Change in Shoulder Pain and Disability Index
时间窗: baseline, 2-weeks, 4-weeks, 3 months
The SPADI Pain subscale is measured on a 0-130 scale. Greater scores indicate increased pain. Patient must have score of 20% or greater to participate in study on both the pain and disability section.
Change in Shoulder Pain (NPRS) (Rating Score)
时间窗: baseline, 2-weeks, 4-weeks, 3 months
Rating Score. Baseline score must exceed 2/10 to be included in the study.
次要结局
- Change in Global Rating of Change Score(2 week, 4 weeks, 3 months)
- Change in Medication Intake (Frequency of medication intake in last week)(baseline, 3 months)
研究者
James Dunning, DPT, MSc, FAAOMPT
Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy
Alabama Physical Therapy & Acupuncture