Clinical trial NCT03090685: Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
Official title: Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chikungunya Fever
Keywords: Chikungunya Fever
Pain
Mobility Limitation
Auriculotherapy
Complementary Therapies
Physical Therapy
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-blind randomized controlled trial (RCT).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* individuals aged ≥ 18 years;
* with medical or other referral from the Family Health Strategy due to symptoms resulting from Chikungunya fever confirmed by clinical or laboratory criteria;
* be able to understand instructions and answer the questions asked by the interviewer.

Exclusion Criteria:

* complaints of pain unrelated to the lower limbs;
* presence of malignant neoplastic disease;
* history of traumatic injury or the lower limb and surgery in the last 12 months;
* congenital deformation;
* pregnancy;
* history of treatment with with Auriculotherapy, acupuncture or physiotherapy in the last four weeks;
* use of steroid medication in the last month;
* use of opioids during the study period;
* do not sign the Free and Informed Consent Form (TCLE).

Primary outcomes:
measure: Pain Numerical rating scale (NRS)
timeFrame: collected at baseline up to 2 months after therapy
measure: Timed Up and Go Test (TUG)
timeFrame: collected at baseline up to 2 months after therapy
Secondary outcomes:
measure: World Health Disability Assessment Schedule (WHODAS 2.0)
timeFrame: collected at baseline up to 2 months after therapy
measure: Short Physical Performance Battery (SPPB)
timeFrame: collected at baseline up to 2 months after therapy
measure: Reducing the use of pain medication
timeFrame: collected at baseline up to 2 months after therapy
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Grupo de Atenção Integral e Pesquisa em Acupuntura e Medicina Tradicional Chinesa - GAIPA
state: Ceará
Study officials:
affiliation: Federal University of Minas Gerais
name: Renata N Kirkwood, doctor
role: STUDY_DIRECTOR
References: