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临床试验/NCT07523126
NCT07523126进行中(未招募)不适用

EFFECT OF TRANSCUTANEOUS ELECTRONEURO-STIMULATION OF THE VAGUS NERVE ON JOINT PAIN SEQUELAE OF CHIKUNGUNYA FEVER IN THE LOWER LIMBS

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2025年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
51
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

This study aims to evaluate the efficacy of transcutaneous electrical nerve stimulation (taVNS) in reducing chronic lower limb joint pain in individuals with sequelae of Chikungunya fever. Post-Chikungunya chronic pain is a prevalent and disabling condition associated with persistent inflammation, neuroimmune alterations, and central sensitization mechanisms, which negatively impact functionality and quality of life. Given the lack of specific treatments with established efficacy, vagal neuromodulation emerges as a promising approach. This is a randomized, controlled, parallel, three-arm clinical trial involving adults with chronic joint pain lasting at least three months after Chikungunya infection. Participants will be randomly assigned (1:1:1) to one of three groups: taVNS, peripheral TENS (active control), or sham stimulation (placebo). The study will use a double-blind design for both participants and evaluators. The interventions will take place twice a week for three weeks, totaling six 30-minute sessions. taVNS will be applied to the superior concha of the left ear using standardized parameters, with intensity adjusted to a comfortable sensory threshold. The active control group will receive TENS on the painful joint, while the sham group will receive auricular stimulation without effective vagal activation. The primary outcome will be the change in pain intensity, assessed using the Visual Analogue Scale. Secondary outcomes will include quality of life (SF-36), pressure pain threshold, joint temperature, and functional performance (Timed Up and Go). The analysis will follow the linear mixed-effects using repeated measures models. The results are expected to strengthen the evidence for taVNS as a non-pharmacological intervention for managing chronic post-Chikungunya pain.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People of either sex who are over 18 years of age, Clinical diagnosis of Chikungunya confirmed by laboratory test and/or medical report; Chronic joint pain in one or more lower limb joints lasting at least 3 months after infection; Ability to ambulate independently or with assistive devices; Intact skin integrity in the auricular region and areas of electrode placement; Residing in the state of Pernambuco.

排除标准

  • Neurological disorders; Decompensated cardiorespiratory diseases; Pre-existing systemic rheumatic diseases prior to Chikungunya infection; History of seizures or epilepsy; Presence of implanted electronic devices (e.g., pacemakers); Pregnancy; Orofacial or ear pain; Skin lesions, infections, or impaired sensation at stimulation sites; Thrombophlebitis, ischemic or ulcerated areas; Neoplasms; Use of medications or substances that increase seizure risk; Current participation in other physiotherapy treatments during the study period; Conditions that prevent attendance at the study site.

研究组 & 干预措施

Group 1

Experimental

Individuals receiving a TENS current application protocol in the superior concha of the left ear, the outer ear area innervated by the auricular branch of the vagus nerve. They recive the tVNS intervention.

干预措施: Transcutaneous vagus nerve electrical stimulation (Device)

Group 2

Active Comparator

Individuals receiving a TENS current application protocol in a painful lower limb joint (knee or ankle)

干预措施: Transcutaneous eletrical nerve stimuation (Device)

G3

Sham Comparator

individuals receiving a TENS current in the left ear lobe only, an area not innervated by the auricular branch of the vagus nerve, without effective vagal activation

干预措施: Transcutaneous electrical nerve stimulation (Device)

结局指标

主要结局

Visual Analogue Scale

时间窗: Baseline and immediately after the 3-week intervention period

The visual analog pain scale (VAS) is used, a one-dimensional instrument for assessing pain intensity. It is a line whose ends are numbered 0-10. One end of the line is marked "no pain" and the other "worst pain imaginable".

次要结局

  • Quality of life (SF-36)(Baseline and post-intervention (3 weeks))
  • Pressure Pain Threshold(Baseline and post-intervention (3 weeks))
  • Digital thermography(Baseline and post-intervention (3 weeks))
  • Timed Up and Go(Baseline and post-intervention (3 weeks))

研究者

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

Luiza Moneta Araújo

lmaraujo

Universidade Federal de Pernambuco

研究点 (1)

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