跳至主要内容
临床试验/NCT06562933
NCT06562933招募中不适用

Comparison of Efficiency of Interferential Current Application Methods in Chronic Neck Pain

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
The Numerical Pain Rating Scale

研究概览

简要总结

The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes.

详细描述

Neck pain is quite common in the adult population and is a frequent reason for seeking medical attention. The prevalence of neck problems has increased with modern lifestyle changes. In individuals with neck pain, symptoms may resolve on their own within a few weeks, but approximately 30% of cases can become chronic. Neck pain lasting 1-4 weeks is considered acute; 4-12 weeks is subacute; and neck pain persisting for 12 weeks or more is considered chronic. Interferential current therapy is used in the treatment of chronic neck pain and is one of the physical therapy methods with analgesic effects. It is widely used around the world. Interferential Current Therapy can be applied using two types of electrodes: vacuum electrodes and carbon-silicon pad electrodes.The aim of this study is to evaluate the effects of Interferential Current Therapy on pain, disability, and quality of life in patients with chronic neck pain and to compare the effects of applying Interferential Current Therapy with vacuum electrodes versus carbon-silicon pad electrodes

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
Single (Investigator)

入排标准

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

入选标准

  • Patients with chronic neck pain lasting at least 3 months
  • Ages between 20 and 50 years

排除标准

  • Patients with inflammatory or infectious diseases and those with radiculopathy or myelopathy symptoms
  • Patients for whom electrotherapy is contraindicated (e.g., those with pregnancy, neurological conditions such as epilepsy, inner ear hearing aids, arrhythmias, pacemakers, active infections, skin lesions, etc.)
  • Individuals with a history of malignancy, major surgery, or previous trauma
  • Individuals who have received physical therapy within the last year
  • Patients whose evaluation could not be completed for any reason
  • Patients who do not wish to complete their evaluations for any reason

研究组 & 干预措施

Sham vacuum

Sham Comparator

Sham vacuum

干预措施: Sham vacuum (Device)

Interferential Current Therapy Vacuum Electrodes

Active Comparator

Interferential Current Therapy Vacuum Electrodes

干预措施: Interferential Current Therapy Vacuum Electrodes (Device)

Interferential Current Therapy Carbon-silicon Pad Electrodes

Active Comparator

Interferential Current Therapy Carbon-silicon Pad Electrodes

干预措施: Interferential Current Therapy Carbon-silicon Pad Electrodes (Device)

结局指标

主要结局

The Numerical Pain Rating Scale

时间窗: 2 week after treatment

It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.

Pressure Pain Threshold

时间窗: 2 week after treatment

A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.

Neck Bournemouth Questionnaire

时间窗: 2 week after treatment

Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.

Neck Disability Index

时间窗: 2 week after treatment

The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.

The Numerical Pain Rating Scale

时间窗: Before treatment

It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain.In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.

Pressure Pain Threshold

时间窗: Before treatment

A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (BaselineR Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.

Neck Bournemouth Questionnaire

时间窗: Before treatment

Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.

Neck Disability Index

时间窗: Before treatment

The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.

次要结局

未报告次要终点

研究者

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

Serdar Kilinc

Assistant professor

Abant Izzet Baysal University

研究点 (1)

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