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临床试验/NCT05782621
NCT05782621尚未招募不适用

Acupoint Focused Ultrasound Versus Laserpuncture In Chronic Mechanical Neck Pain

Cairo University0 个研究点目标入组 45 人开始时间: 2023年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
pain intensity

研究概览

简要总结

this study will be conducted to compare the effect of Acupoint focused ultrasound and Laser puncture on pain intensity level, neck range of motion, and neck function in patient with chronic mechanical neck pain

详细描述

Neck pain is a musculoskeletal condition with a high prevalence that may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain was significantly associated with repetitive movement, activities that require lifting and moving loads, and being in sitting and leaning positions.Non specific neck pain is a multifactorial and very common condition in adult individuals, traditional acupuncture (TA) and laser puncture (LP) may be treatment options for certain individuals in such a condition. The laser will be placed at the specific acupuncture points: Tianzhu, Fengchi, Jianjing, and Jianzhongshu . Because ultrasound can deliver vibration energy to soft tissues noninvasively, ultrasound has been applied to diagnostic imaging and therapeutic applications. To use ultrasound for acupoint stimulation, a stimulation device was developed using focused ultrasound. The application of an ultrasound stimulus to the acupuncture meridian system has been found safe and effective in many common clinical entities. The Sonicator head is applied to the chosen location as in standard ultrasound therapy, with a gentle circular motion. forty five patients will be assigned randomly to three groups; experimental group 1 will receive acupoint focused ultrasound, experimental group 2 will receive laserpuncture and the control group will receive conventional treatment three times a week for four weeks.

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 (Investigator, Outcomes Assessor)

盲法说明

opaque sealed envelop

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects will be referred by the orthopedist. Cervical pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months.
  • The subject is willing and able to refrain from non-study procedure therapies for the management of neck pain throughout study participation.
  • Age ranged from 30-60 years BMI ranged from (25-30kg/m2)

排除标准

  • Cervical pain is undiagnosed or has been diagnosed as being other than of benign musculoskeletal origin.
  • Tension myositis syndrome. Osteoporosis with compression fractures. Congenital deformity of spine. Current active chronic pain disease. Cancer or cancer treatment in the past 6 months. Use of the following analgesics within 7 days of study onset - paracetamol, acetominophen, non-steroidal anti-inflammatory drugs (NSAIDs), compound analgesics, topical analgesics.
  • Use of the following muscle relaxants within the prior 30 days of study onset - cyclobenzaprine, diazepam, meprobamate.

结局指标

主要结局

pain intensity

时间窗: up to four weeks

pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)

Disability

时间窗: up to four weeks

The Copenhagen Neck Functional Disability Scale will be used to evaluate the disability experienced by patients with neck pain. it consists of 15 items. These items are individually answered by either 'yes', 'occasionally' or 'no'. For questions one till five, a 'yes' indicates a good function. For questions six till fifteen, a 'no' indicates a good function. A good function receives a score of zero, a poor function receives a score of two and the answer 'occasionally' always receives a score of one. Afterwards, we add up all the scores of the questions to form the total score. This total score ranges from 0 to 30.The total score determines the level of functional disability, in which higher numbers represent a higher level of disability. A score of 0 indicates that there are no neck complaints present whereas 30 indicates that the patient is extremely disabled as a result of the neck complaints

次要结局

  • cervical range of motion(up to four weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Ahmed Ahmed Asr

principle investigator Dina Ahmed Ahmed Asr

Cairo University

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