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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Group 2 | Active Comparator | Individuals receiving a TENS current application protocol in a painful lower limb joint (knee or ankle) |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and post-intervention (3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Pernambuco - Department of Physiotherapy, Electrophototherapy Laboratory | Recife | Pernambuco | 50670-420 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. BrasÃlia (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 |
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| 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. |
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| Transcutaneous electrical nerve stimulation | Device | The sham stimulation mimics the sensory experience of active stimulation without producing therapeutic neuromodulatory effects. |
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| 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. | Baseline and post-intervention (3 weeks) |
| Digital thermography | Joint temperature will be assessed using infrared thermography under controlled environmental conditions to evaluate changes associated with inflammation. | Baseline and post-intervention (3 weeks) |
| 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. | Baseline and post-intervention (3 weeks) |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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