NCT04609735招募中不适用
Manual Therapy, Exercise and Ultrasound Vs. Manual Therapy, Exercise, Ultrasound and Electric Dry Needling for Patients With Medial Epicondylalgia
Alabama Physical Therapy & Acupuncture2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in elbow pain intensity (NPRS)
研究概览
简要总结
The purpose of this research is to compare two different approaches for treating patients with medial epicondylalgia: manual therapy, exercise and ultrasound and manual therapy, exercise, ultrasound and electric dry needling. Physical therapists commonly use all of these techniques to treat medial epicondylalgia. This study is attempting to find out if one treatment strategy is more effective than the other.
详细描述
Patients with medial epicondylalgia will be randomized to receive 8 treatments (2 treatments per week) over 4 weeks (8 treatments max) of either: 1. manual therapy, exercise and ultrasound or 2. manual therapy, exercise, ultrasound and electric dry needling
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult between18 and 60 years old that is able to speak English.
- •Report of at least 6 weeks of elbow (i.e. medial epicondyle) and ventral forearm pain, consistent with medial epicondylalgia.
- •Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months.
- •Diagnosis of medial epicondylalgia, defined as the following:(Walz, 2010; Shin, 2019)
- •Tenderness is elicited by palpation of the insertion of the flexor-pronator mass (5-10 mm distal and anterior to the middle aspect of the medial epicondyle)
- •Pain is exacerbated by resisted wrist flexion and forearm pronation at an angle of 90°
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.
- •Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture.
- •History of or presentation consistent with osteochondritis dissecans, osteoarthrosis, MCL injury (i.e. Pain with valgus stress or positive "milking test" - pulling on the thumb with the elbow in flexion and the forearm in supination), flexor-pronator strain, and ulnar neuropathy (i.e. Positive Tinel sign - distal pain and tingling during direct compression of the nerve at the elbow).
- •Report of systemic neurological disorders and/or neurological deficits to include the following: a. Nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity deep tendon reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome) b. Cervical or thoracic spinal stenosis (exhibited by bilateral upper extremity symptoms) c. Central nervous system involvement (hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes) d. History of whiplash or T-spine injury injury within the previous 6 weeks
- •History of surgery to the head/neck/T-spine or affected upper extremity.
- •6. Psychiatric disorders or cognitively impaired
结局指标
主要结局
Change in elbow pain intensity (NPRS)
时间窗: Baseline, 1-week, 4-weeks, 3-months
Numeric Pain Rating Score. Higher scores mean greater pain
次要结局
- Disabilities of the Arm, Shoulder and Hand(Baseline, 1-week, 4-weeks, 3-months)
- Change in Global rating of change score(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
Director, American Academy of Manipulative Therapy
Alabama Physical Therapy & Acupuncture
研究点 (2)
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