Electric Dry Needling, Thrust Manipulation and Stretching Versus Impairment-based Manual Therapy, Exercise and Ultrasound for Patients With Lateral Epicondylalgia: 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
- 143
- 试验地点
- 2
- 主要终点
- Change in Elbow pain (NPRS) (Rating Score)
研究概览
简要总结
The purpose of this research is to compare two different approaches for treating patients with lateral epicondylalgia: electric dry needling, thrust manipulation and stretching versus impairment-based manual therapy, exercise and ultrasound. Physical therapists commonly use all of these techniques to treat lateral epicondyalgia. This study is attempting to find out if one treatment strategy is more effective than the other.
详细描述
Patients with epicondyalgia will be randomized to receive 2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) electric dry needling, thrust manipulation and stretching or (2) impairment-based manual therapy, exercise and ultrasound
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 between 18 and 60 years old that is able to speak English.
- •Report of at least 6 weeks of elbow (i.e. lateral epicondyle) and dorsal forearm pain, consistent with lateral epicondylitis:
- •Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months:
- •Diagnosis of lateral epicondylitis, defined as two of more of the following:
- •Pain on palpation over the lateral epicondyle and the associated common extensor unit
- •Pain on gripping a hand dynamometer
- •Pain with stretching or contraction of the wrist extensor muscles
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
- •Report of systemic neurological disorders and/or neurological deficits to include the following:
- •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)
- •Cervical spinal stenosis (exhibited bilateral upper extremity symptoms)
- •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)
- •History of whiplash injury within the previous 6 weeks
- •History of surgery to the head/neck or affected upper extremity.
- •Psychiatric disorders or cognitively impaired
结局指标
主要结局
Change in Elbow pain (NPRS) (Rating Score)
时间窗: Baseline, 1 week, 4 weeks, 3 months
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Patient-related Tennis Elbow Questionnaire
时间窗: Baseline, 1 week, 4 weeks, 3 months
The pain, disability-specific activities and disability common activities section of the PRTEE are collectively measured on a 0-150 point scale. Greater scores indicate increased disability. Baseline must exceed 10/50 on the pain section, 10/60 on the specific activities section and 10/40 on the common activities to be included in the study.
次要结局
- Change in Global Rating of Change Score(1 week, 4 weeks, 3 months)
- Change in Medication Intake (Frequency of medication intake in last week)(Baseline, 3 months)
- Change in Tennis Elbow Functional Scale(Baseline, 1 week, 4 weeks, 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