跳至主要内容
临床试验/NCT06762574
NCT06762574尚未招募不适用

"Effect of Low Level Laser Therapy on Neuropathic Pain After Neck Dissection Surgery''

Cairo University0 个研究点目标入组 52 人开始时间: 2025年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
主要终点
Neck Neuropathic pain

研究概览

简要总结

The purpose of the study was to evaluate the effect of Low Level Laser Therapy on neuropathic pain after neck dissection surgery.

It was hypothesized that: Low Level Laser Therapy is effective on improving Neuropathic pain post neck dissection surgery .

详细描述

Patients diagnosed with head and neck cancer are treated with surgery, radiation therapy and/or chemotherapy, with the aim of maximizing survival whilst preserving physical form and function .The surgical dissection of the neck is a typical technique for the management of head and neck malignant growths from the squamous cell carcinoma .

Neck dissection (ND) is performed for known metastatic neck disease, prophylactically in cases where there is increased risk for occult metastatic disease or as a staging procedure. Neck dissection (ND) is used to treat known metastatic neck disease, as a preventative measure against occult metastatic disease. A common surgery for treating malignant growths of the head and neck caused by SCC is surgical ND.

There are various approaches to performing the neck dissection surgery. One of these approaches is the radical neck dissection that involves the total excision of lymph nodes from one side of the neck, the muscle that helps turn the head (sternocleidomastoid muscle), a significant vein (internal jugular vein), and a nerve that is essential in the full-range of movement of the arm and shoulder (spinal accessory nerve).In contrast, the modified radical neck dissection preserves one or more of the aforementioned important structures .

Neck morbidity was common and apparent after cancer treatment; this includes limited ROM, impairment of sensations, and neck pain . In an investigation of 25 patients with permanent neck pain following neck dissection, two types of neck pain were described;neuropathic and myofascial pains.

Furthermore, shoulder and neck symptoms were reported in 37% and 33% of 220 participants who had neck dissection surgery , respectively, while myofascial and neuropathic pains were reported in 46% and 32% of the patients, respectively .

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
None

入排标准

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

入选标准

  • •Fiftyـtwo patients of both genders with age ranged between 30 to 60 years will participate in this study.
  • •All patients had neuropathic pain following Unilateral radical neck dissection surgery.
  • •All patients had history of neuropathic pain involving superficial cervical plexus after unilateral radical neck dissection surgery.
  • •All patients had moderate or severe pain of tingling,numbness and electric nature following neck dissection surgery. NP confined to the C2-C4 distributions, involves one or more branches of the SCP;especially in the skin overlying lateral neck .
  • •Informed consent was obtained from every patient enrolled in the trial.
  • •Moderate to severe pain (VAS score >4).

排除标准

  • •A wound in the affected area.
  • •A cervical disk lesion.
  • •Cervical spine fracture or spondylolisthesis.
  • •Rheumatoid arthritis.
  • •Epilepsy or any psychological

研究组 & 干预措施

Study group receive low level laser Therapy and traditional medical treatment

Active Comparator

干预措施: Low Level Laser Therapy (Other)

Control group receive placebo Low Level Laser Therapy and traditional medical treatment

Placebo Comparator

干预措施: Placebo Low Level Laser Therapy (Other)

结局指标

主要结局

Neck Neuropathic pain

时间窗: 6 weeks

\* Douleur Neuropathique 4 questionnaire : It is a screening questionnaire to identify neuropathic pain in clinical practice and research, it showed significant accuracy of 83% sensitivity and 90% specificity.It is made up of seven items related to symptoms and three items related to physical evaluation . Each item is scored 1 if the answer is positive and zero if negative, leading to a minimum score of zero and maximum of 10. Cut-off point is four, being that scores equal to or above 4 suggest neuropathic pain .

次要结局

  • Neck pain(6 weeks)
  • Neck Rang of motion(6 weeks)

研究者

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

Dalia Fathi Ragab Gawish

Physical therapist

Cairo University

相似试验