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临床试验/NCT02522403
NCT02522403已完成不适用

Application of Laser Acupuncture in Rehabilitating Patients With Distal Radius Fracture

Universidad Autonoma de Nuevo Leon2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Patient-Rated Wrist Evaluation (PRWE)

研究概览

简要总结

The patients with distal radius fracture treated with immobilization (cast) and percutaneous pinning it will be to able to participate in this randomized trial. The investigators will be able to determine if the laser acupuncture is a good therapy for the rehabilitation in this type of patients. And if they are more comfortable to begin his rehabilitation exercise after the application of this therapy

详细描述

Distal radius fractures are very common, ranging between 17 and 20% of all diagnosed fractures, and are the most common fractures treated by orthopedic surgeons in adult patients. It is defined as a fracture of the distal radius, which is less than 2.5 cm from the radiocarpal joint. Usually it is the result of falling on the outstretched hand. These fractures occur in all age groups and a bimodal distribution is observed with a peak incidence predominantly young adult patients and another peak in older women.

In order to achieve successful functional results in distal radius fracture both an adequate treatment and timely and specific rehabilitation are required. The distal radius fracture guidelines generally indicate that rehabilitation therapy should begin at four to six weeks post injury or surgery after cast or external fixator is removed initiating passive/active ranges of motion exercises for the fingers, wrist and forearm. Patients are encouraged to use the wrist at home for light activities. At nine to 12 weeks post injury patients can initiate grip strengthening.

There is limited available literature on the effect of acupuncture in the treatment of fractures. Two case reports claim to have achieved an acceleration of bone healing and pain management of patients with proximal humerus fracture when treated with a combination of acupuncture, electro-acupuncture and herbal medicine. Another study concluded that electroacupuncture plus radiation therapy with infrared rays and passive exercises was clearly superior to therapy with only exercises after surgery for humerus fracture.

There is a modality of acupuncture using low level laser therapy, which is useful for tissue regeneration in general and to stimulate acupuncture points. Current clinical research has confirmed the therapeutic usefulness of laser acupuncture in and equine laminitis and in humans in treating myofascial pain, tennis elbow, knee osteoarthritis and other musculoskeletal diseases.

The low level laser therapy, is a type of noninvasively phototherapy that has been shown to modulate various biological processes depending on the power density, wavelength and frequency. A recent study using rats showed that laser stimulation of acupuncture point (located in the leg) caused a significant antinociceptive effect controlling the behavior induced in rats caused by pain after peritoneal injection of acetic acid and injection of formalin in rat paws. The effect is mediated by activation of the opioidergic and serotoninergic systems (5HT-1 and 5HT-2A receptors).

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

入选标准

  • Distal radius fracture treated with percutaneous pinning and plaster
  • Type A2, A3, B1 and B2 of the Orthopedic Trauma Association classification

排除标准

  • Rheumatoid arthritis
  • Ipsilateral fractures
  • Psychiatric illness
  • Previous wrist fracture or surgery

结局指标

主要结局

Patient-Rated Wrist Evaluation (PRWE)

时间窗: 6 weeks

The PRWE assesses pain and the inability to perform daily acitivities. Is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. It yields a score of 0 to 100, with lower scores indicanting better performance. Only the final results of the study are reported.

次要结局

  • Visual Analogue Scale (VAS)(6 weeks)
  • Wrist Mobility(6 weeks)

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos A Acosta-Olivo

MD, PhD

Universidad Autonoma de Nuevo Leon

研究点 (2)

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