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Chronic Pain ManagementNCT07523126

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

A study testing Transcutaneous vagus nerve electrical stimulation, Transcutaneous eletrical nerve stimuation and Transcutaneous electrical nerve stimulation in people with Chronic Pain Management and Chronic Pain and Comorbid Emotional Problems, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transcutaneous vagus nerve electrical stimulation, Transcutaneous eletrical nerve stimuation and Transcutaneous electrical nerve stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteBrazil
Study dates
4 Feb 2025to 15 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of Pernambuco - Department of Physiotherapy, Electrophototherapy Laboratory

    Recife, Pernambuco, 50670-420

Other trials in Brazil

About this study

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.

Being tested
Transcutaneous vagus nerve electrical stimulation, Transcutaneous eletrical nerve stimuation, Transcutaneous electrical nerve stimulation
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous vagus nerve electrical stimulationDevice

    Also called taVNS

    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.

  • Transcutaneous eletrical nerve stimuationDevice

    Also called Peripheral TENS

    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.

  • Transcutaneous electrical nerve stimulationDevice

    Also called Sham taVNS

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

Study groups in NCT07523126
Study groupRoleWhat they receive
Group 1ExperimentalIndividuals 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.
Receives: Device: Transcutaneous vagus nerve electrical stimulation
Group 2Active comparatorIndividuals receiving a TENS current application protocol in a painful lower limb joint (knee or ankle)
Receives: Device: Transcutaneous eletrical nerve stimuation
G3Sham comparatorindividuals 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
Receives: Device: Transcutaneous electrical nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: Baseline and immediately after the 3-week intervention period

Secondary outcomes (4)

  1. Quality of life (SF-36)

    The 36-item Medical Outcomes Study Short-Form Health Survey (SF-36) is used to assess quality of life. It consists of 36 items covering 8 domains: Functioning (10 items), physical aspects (4 items), pain (2 items), general health (5 items), vitality (4 items), social aspects (2 items), emotional aspects (3 items), mental health (5 items).

    Measured: Baseline and post-intervention (3 weeks)

  2. Pressure Pain Threshold

    A KRATOS pressure algometer (PA), model DDK electronic, with a flat, circular metal probe with a diameter of 01 cm and a pressure in kilogram force (kgf) is used to measure the pressure pain threshold.

    Measured: Baseline and post-intervention (3 weeks)

  3. Digital thermography

    Joint temperature will be assessed using infrared thermography under controlled environmental conditions to evaluate changes associated with inflammation.

    Measured: Baseline and post-intervention (3 weeks)

  4. Timed Up and Go

    An Android smartphone with the MOMENTUM SCIENCE app installed is used to assess the dynamic balance. The smartphone is attached to the lumbar region between L3 and L5 with a Velcro strap to hold it in place and the Time UP and Go (TUG) test is performed.

    Measured: Baseline and post-intervention (3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start4 Feb 2025
  3. Primary completion10 Apr 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07523126
Sponsor's protocol ID
83524324.0.0000.5208
Status last verified
Apr 2026
First submitted
4 Apr 2026
Last updated
13 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous vagus nerve electrical stimulation, Transcutaneous eletrical nerve stimuation and Transcutaneous electrical nerve stimulation in people with Chronic Pain Management and Chronic Pain and Comorbid Emotional Problems, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: Baseline and immediately after the 3-week intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07523126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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