Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
Condition: Chikungunya Fever
MeSH terms: Chikungunya Fever; Fever
Study type: Interventional

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.
    

Intervention name(s): True auriculotherapy with seeds; Placebo Auriculotherapy with seeds
Intervention type(s): Procedure; Procedure
Intervention description(s): Roasted edible mustard seeds with ~ 2mm diameter fixed with adhesive tape in 4 to 5 specific body points to control musculoskeletal pain.; Roasted edible mustard seeds with ~ 2mm diameter fixed with adhesive tape at 4 points located in the auricular lobe not specific for musculoskeletal pain.
Other intervention name(s): Auriculotherapy complementary to the drug therapy; Placebo Auriculotherapy complementary to usual treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double-blind randomized controlled trial (RCT).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chikungunya Fever; Pain; Mobility Limitation; Auriculotherapy; Complementary Therapies; Physical Therapy