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

NCT07523126 | Active Not Recruiting

• 1 other identifier: 83524324.0.0000.5208
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain Management; Chronic Pain and Comorbid Emotional Problems

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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".

  Baseline and immediately after the 3-week intervention period

Secondary Outcomes (4)

• 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)

Study Arms (3)

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.

Device: Transcutaneous vagus nerve electrical stimulation

Group 2

ACTIVE COMPARATOR

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

Device: Transcutaneous eletrical nerve stimuation

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

Device: Transcutaneous electrical nerve stimulation

Interventions

Transcutaneous vagus nerve electrical stimulation DEVICE

The transcutaneous vagus nerve electrical stimulations is a non-pharmacological analgesic intervention for the treatment of pain and has been shown to be beneficial in epilepsy, depression, chronic pain and inflammatory diseases.

Also known as: taVNS

Group 1

Transcutaneous eletrical nerve stimuation DEVICE

The transcutaneous eletrical nerve stimulation is another non-pharmacological analgesic intervention for the treatment of chronic and acute pain, it has studies about it effectiveness in this types of pain for 50 years.

Also known as: Peripheral TENS

Group 2

Transcutaneous electrical nerve stimulation DEVICE

The sham stimulation mimics the sensory experience of active stimulation without producing therapeutic neuromodulatory effects.

Also known as: Sham taVNS

G3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Federal University of Pernambuco - Department of Physiotherapy, Electrophototherapy Laboratory

Recife, Pernambuco, 50670-420, Brazil

Location

Related Publications (1)

• Aguiar-Santos M, et al. Spatial analysis of the incidence of Chikungunya fever and associated socioeconomic, demographic and vector infestation factors in municipalities of Pernambuco, Brazil, 2015-2021. 2023;26. Badran BW, et al. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: a concurrent taVNS/fMRI study and review. Brain Stimul. 2018;11(3):492-500. Botha C, et al. Modulation of parasympathetic nervous system tone influences oesophageal pain hypersensitivity. Gut. 2015;64(4):611-617. Brazil Ministry of Health. Health Surveillance Guide. 5th ed. Brasília (DF): Ministry of Health; 2022. Butt MF, et al. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020;236(4):588-611. Irigoyen MC, et al. Revisiting sympathetic nervous system physiology: what's new? Rev Bras Hipertens. 2014;24(2):9-15. Crossman AR, Neary D. Neuroanatomy: An Illustrated Colour Text. Rio de Janeiro: Elsevier; 1997. Farmer AD, Aziz Q. Vagally mediated analgesia: breath-holding during exhalation as a simple manipulation to reduce pain perception. Pain Med. 2015;16(12):2417-2418. Hamer HM, Bauer S. Lessons learned from transcutaneous vagus nerve stimulation (tVNS). Epilepsy Behav. 2019;83-84. Hartley S, et al. Noninvasive vagus nerve stimulation: a new therapeutic approach for pharmacoresistant restless legs syndrome. Sleep Med. 2023;26(3):629-637. Lopes N, Nozawa C, Linhares REC. General characteristics and epidemiology of emerging arboviruses in Brazil. Rev Pan-Amaz Saude. 2014;5(3). Martinez JE, Grassi DC, Marques LG. Analysis of the applicability of three pain assessment instruments in different care units: outpatient, ward and emergency. Rev Bras Reumatol. 2011;51(4):299-308. Mesquita R, et al. Brazilian-Portuguese version of the SF-36: a reliable and valid quality of life out

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lmaraujo

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: February 4, 2025
• Primary Completion: April 10, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

BR (1)