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临床试验/NCT06767839
NCT06767839
已完成
不适用

The Effect of Different Electrotherapy Interventions on Pain and Hand Function in Young Individuals With Neck Pain: a Randomized Controlled Double-blind Trial

Burdur Mehmet Akif Ersoy University1 个研究点 分布在 1 个国家目标入组 36 人2025年1月15日

概览

阶段
不适用
干预措施
Transcutaneous Electrical Nerve Stimulation
疾病 / 适应症
Neck Pain
发起方
Burdur Mehmet Akif Ersoy University
入组人数
36
试验地点
1
主要终点
Visual Analog Scale
状态
已完成
最后更新
上个月

概览

简要总结

The aim of this clinical study was to investigate the effects of different electrotherapy interventions on pain and hand function in young individuals with neck pain.

The main question that the study aimed to answer is: are two different electrotherapy interventions superior to each other for pain and hand function? Participants will be assigned to either transcutaneous electrical nerve stimulation, high-voltage pulsed galvanic stimulation, or placebo. Participants will receive a total of 20 sessions of electrotherapy intervention, 20 minutes per day, 3 days a week. Participants will be evaluated before the intervention, after 1 session, and 1 week after the completion of the 20-session intervention.

注册库
clinicaltrials.gov
开始日期
2025年1月15日
结束日期
2025年12月21日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Burdur Mehmet Akif Ersoy University
责任方
Principal Investigator
主要研究者

Betül Söylemez

Lecturer, PT.MSc.

Burdur Mehmet Akif Ersoy University

入排标准

入选标准

  • Being between 18-30 years old
  • Complaining of neck pain
  • Volunteering to participate in the study

排除标准

  • Having received any anti-inflammatory treatment in the last 3 months
  • Having received any physical therapy and rehabilitation treatment in the last 3 months
  • Doing regular exercise
  • Not attending work sessions

研究组 & 干预措施

Group of Transcutaneous Electrical Nerve Stimulation (TENS)

Participants assigned to this group will receive TENS for 20 minutes each session for a total of 20 sessions.

干预措施: Transcutaneous Electrical Nerve Stimulation

Group of High Voltage Pulsed Galvanic Stimulation (HVPGS)

Participants assigned to this group will receive HVPGS for 20 minutes each session for a total of 20 sessions.

干预措施: High Voltage Pulsed Galvanic Stimulation

Group of sham

Individuals assigned to this group will be started on TENS current for a total of 20 sessions, each session lasting 20 minutes, but the current will be reduced and turned off after 1 minute. It will be explained to the individuals that this current is applied at a subthreshold level.

干预措施: Sham TENS

结局指标

主要结局

Visual Analog Scale

时间窗: From enrollment to the end of treatment at 7 weeks

The Visual Analog Scale is a 10-centimeter (cm) scale, with 0 being defined as "no pain" and 10 as "unbearable pain." It is a valid and reliable method for assessing the severity of musculoskeletal pain and is frequently used in clinical studies. In a study conducted on patients with chronic musculoskeletal pain, a VAS value of less than 3.4 cm was classified as mild pain, a VAS value between 3.5 and 7.4 cm was classified as moderate pain, and a VAS value greater than 7.5 cm was classified as severe pain.

Treshold Faradic Test

时间窗: From enrollment to the end of treatment at 7 weeks

Pain threshold measurement is performed by applying a surge faradic current with a frequency of 50 Hz and a transition time of 0.1-1 msec. The point at which the current is first felt is defined as the pain threshold. In this test, the active electrode is placed at the motor point of the relevant muscle, while the passive electrode can be placed in a more distal or proximal region.

Patient-Specific Functional Scale

时间窗: From enrollment to the end of treatment at 7 weeks

Patients are asked to list the three activities that cause the most difficulty with their neck pain. Each activity is then scored from 0 (unable to perform the activity) to 10 (able to perform the activity at the same level as before the onset of symptoms).

Core Outcome Meassure Index-Neck

时间窗: From enrollment to the end of treatment at 7 weeks

It is a symptom-specific measurement tool that includes all the parameters that need to be evaluated in patients with low back pain (pain, function, quality of life, disability), and has the advantages of being short and easy to apply. It consists of six questions and each question is scored between 0 and 10. Higher scores indicate worse results.

次要结局

  • Nine-Hole Peg Test(From enrollment to the end of treatment at 7 weeks)
  • Gross Grip Strength(From enrollment to the end of treatment at 7 weeks)
  • Pinch Grip Strength(From enrollment to the end of treatment at 7 weeks)
  • Upper Extremity Strenght(From enrollment to the end of treatment at 7 weeks)
  • Semmes-Weinstein Monofilament Test(From enrollment to the end of treatment at 7 weeks)
  • Cervical Endurance Test(From enrollment to the end of treatment at 7 weeks)

研究点 (1)

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