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临床试验/CTRI/2025/07/091468
CTRI/2025/07/091468尚未招募不适用

Neck muscle activity in individuals undergoing cervical spine surgery—a single-group pre-post study

Preeti S Agrawal1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年8月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
37
试验地点
1
主要终点
Percentage maximum voluntary contraction from EMG and Numerical Pain Rating Scale (NPRS)

研究概览

简要总结

Title Neck Muscle Activity in Individuals Undergoing Cervical Spine Surgery – A Single Group Pre Post Study

Type of Study Prospective cross sectional study

Aim and Objective To assess neck muscle activity in terms of percentage maximum voluntary contraction before and after cervical spine surgery using surface electromyography

Justification There is limited research on isometric neck muscle activity before and after surgery. Using surface electromyography provides objective data to guide postoperative rehabilitation and improve patient recovery

Study Period April 2025 to March 2026

Sample Size 37 participants including 20 percent dropout rate

Inclusion Criteria Adults aged 18 to 65 years scheduled for elective cervical spine surgery and medically stable

Exclusion Criteria Severe pain score 6 or above on the numerical pain rating scale History of prior neck surgery Cervical trauma or congenital deformity Neurological or musculoskeletal conditions affecting the neck Skin conditions interfering with electrode placement

Tools Used Surface electromyography and numerical pain rating scale

Procedure Muscle activity of the trapezius and sternocleidomastoid will be recorded preoperatively and on the second postoperative day using surface electrodes during specific isometric tasks. Data will be averaged from three trials and compared

Outcome Measures Percentage maximum voluntary contraction and pain score

Statistical Analysis Descriptive statistics, normality testing using Shapiro Wilk test Paired t test or Wilcoxon signed rank test will be used Significance level set at p less than 0 point zero five

Potential Risks Minimal risk involving slight discomfort or fatigue

Benefits Helps design effective rehabilitation protocols Improves neck strength, function, and overall recovery

Ethical Considerations Institutional ethics committee approval Informed consent and confidentiality ensured Participant safety will be prioritized

Literature Review

Previous studies show changes in neck muscle function after cervical spine surgery. Muscle loss and altered activity patterns are linked to poor outcomes. Early identification and rehabilitation are essential to improve patient recovery and quality of life.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients planned for cervical spine surgery Medically stable Age range of 18-65 years.

排除标准

  • NThis study will include patients undergoing elective cervical spine surgery.
  • However, individuals will be excluded if they have a pain score of six or above on the numerical pain rating scale, a history of prior neck surgeries, or coexisting neurological or musculoskeletal conditions that affect the neck muscles.
  • Patients with skin conditions that prevent the application of EMG electrodes, those presenting with cervical vertebral trauma, and individuals with congenital cervical deformities will also be excluded from the study.

结局指标

主要结局

Percentage maximum voluntary contraction from EMG and Numerical Pain Rating Scale (NPRS)

时间窗: 1 day before surgery(baseline) and | 2 days after surgery

次要结局

未报告次要终点

研究者

发起方
Preeti S Agrawal
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Preeti S Agrawal

Manipal College of Health Professions

研究点 (1)

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