Trials / Completed
CompletedNCT03090685
Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Universidade Federal do Ceara · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Chikungunya fever is an acute viral disease, transmitted by the mosquito (Aedes aegypti), that triggers pain and disabling rheumatic manifestations. There is no cure for this disease, and the usual treatment is directed at relieving symptoms through the use of analgesics and antipyretics. Due to the risk of adverse effects triggered by prolonged use of analgesic and anti-inflammatory drugs, the use of complementary therapies, such as Auriculotherapy, might be a safe and effective non-pharmacological treatment for the management of Chikungunya symptomatic cases. Subjects diagnosed with Chikungunya and undergoing routine treatment will receive auricotherapy treatment once a week, for five weeks. Subjects will be assessed at baseline and after 4 and 8 weeks after intervention. This study might help understand the use of Auriculotherapy as a complementary treatment in the treatment of physical and functional symptoms of individuals infected by Chikungunya .
Detailed description
Objectives of the study 1. To evaluate the effectiveness of Auriculotherapy in the management of pain and functional capacity of symptomatic individuals after Chikungunya fever. 2. To evaluate the effects of Auriculotherapy on the intensity of pain, limitation of mobility, and perception of disability and physical capacity. 3. Investigate the effect of Auriculotherapy on pain medication use. Place and study population: Subjects diagnosed with Chikungunya Fever will be recruited for convenience in the basic care of the city of Fortaleza-CE, Brazil, in order to be evaluated and treated by the researcher's team. Procedures and intervention: Subjects will be evaluated at the initial time of the research, and after 4 and 8 weeks of intervention. The description of the procedures will follow the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). Asepsis of the ear with alcohol 70%is necessary to apply 4 to 5 auricular acupuncture points. In the intervention group, specific points will be used to the management of pain and physical function. In the placebo group, non-specific points will be used. Patients will be instructed to exert finger pressure at each point for 3 minutes. At least 3x / day, or whenever they feel pain. These implants will be kept for 5 days and will be taken off by the participant 2 days before the next appointment. Ethical aspects: The research will begin after approval by the Ethics and Research Committee (CEP) of the Federal University of Ceará. All participants will sign the Informed Consent and are free to withdraw from the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | True auriculotherapy with seeds | Roasted edible mustard seeds with \~ 2mm diameter fixed with adhesive tape in 4 to 5 specific body points to control musculoskeletal pain. |
| PROCEDURE | Placebo Auriculotherapy with seeds | Roasted edible mustard seeds with \~ 2mm diameter fixed with adhesive tape at 4 points located in the auricular lobe not specific for musculoskeletal pain. |
Timeline
- Start date
- 2017-05-05
- Primary completion
- 2017-11-01
- Completion
- 2017-11-01
- First posted
- 2017-03-27
- Last updated
- 2018-10-10
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03090685. Inclusion in this directory is not an endorsement.