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临床试验/NCT07313189
NCT07313189已完成不适用

Effect of Stabilizer Pressure Biofeedback on Neck Dysfunction Post Neck Dissection Surgeries

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Deep cervical flexors strength

研究概览

简要总结

Fifty patients of both genders with age ranged from 30 - 50 years, suffering from neck dysfunction post neck dissection surgeries participated in this study. The participants were randomly selected from the National Cancer Institute, Cairo, Egypt. They were randomly assigned into two equal groups, 25 patients each (study group and control group).

Group A :( Study Group) In this group of the study, received cranio-cervical flexion training utilizing stabilizer pressure biofeedback in addition to traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.

Group B :( Control Group) In this group of the study, received traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.

详细描述

1-Subjects: Fifty patients of both genders with age ranged from 30 - 50 years, suffering from neck dysfunction post neck dissection surgeries participated in this study. The participants were randomly selected from the National Cancer Institute, Cairo, Egypt. They were randomly assigned into two equal groups, 25 patients each (study group and control group).

Group A :( Study Group) In this group of the study, received cranio-cervical flexion training utilizing stabilizer pressure biofeedback in addition to traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.

Group B :( Control Group) In this group of the study, received traditional physical therapy program (ROM exercises, stretching and strengthening exercises), 3 times a week for 6 weeks.

2) Equipment:

Therapeutic equipment:

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, Investigator)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The subject selection was according to the following criteria:
  • Patients' age ranged between 30-50 years.
  • Both gender participated in this study.
  • All patients suffered from neck dysfunction (neck pain, limited ROM and disability) following unilateral neck dissection surgeries.
  • All patients suffered from moderate to severe pain (VAS score > 4).
  • All patients undergone modified radical NDS or selective NDS.
  • All patients began the treatment program 2 weeks post neck dissection surgeries
  • All patients enrolled to the study had their informed consent.

排除标准

  • 1- Neck pain due to other underlying conditions such as:
  • Spinal fracture
  • Osteoporosis
  • Spinal cord compression
  • Congenital postural deformities
  • Inflammatory disorders of the spine
  • Spinal infections
  • Significant neurological disorders
  • Rheumatoid arthritis 2- Malignancy 3- Pregnancy 4- History of cervical spine surgery 5- Epilepsy or any psychological disorders

结局指标

主要结局

Deep cervical flexors strength

时间窗: Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).

Strength of DCFs was measured using PBU during the Cranio-Cervical Flexion Test (CCFT). * The subject lied in a supine position on a firm plinth. A pressure biofeedback unit was placed under the suboccipital region, and the pressure cuff was inflated to 20 mmHg to support the natural cervical lordosis. * The subject then instructed to perform a gentle head-nodding movement, similar to saying "yes," which is known as craniocervical flexion. * The subject asked to gradually increase the pressure in increments up to a maximum of 10 mmHg above baseline (i.e., up to 30 mmHg), and hold each pressure level for 10 seconds. The highest pressure level that the subject was able to maintain steadily for 10 seconds was considered the strength level of the deep cervical flexors . * Measurements were taken at baseline (pre-treatment) and after 6 weeks (post-treatment).

次要结局

  • Cervical range of motion(• Measurements were taken at baseline (pre-treatment) and 6 weeks (post-treatment).)
  • Neck pain and disability(• The neck disability index was administered at baseline (pre-treatment) and 6 weeks post-intervention to monitor changes in functional impairment)

研究者

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

Hager Hussein Noah abdelsamea Shaheen

Demonstrator at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University

Cairo University

研究点 (1)

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