Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever

NCT ID: NCT03090685

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-05
• Study Completion Date: 2017-11-01

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.

Conditions

Chikungunya Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

True auriculotherapy with seeds

Auriculotherapy complementary to the usual drug treatment. At each ear, selected points edible seeds of roasted mustard with a size of approximately 2 mm will be used, since it is natural and non-toxic. The seeds will be stored in ear plate and applied with the use of micropore clamp and tape in 4 to 5 specific points to control for musculoskeletal pain.

Group Type: EXPERIMENTAL

True auriculotherapy with seeds

Intervention Type: PROCEDURE

Roasted edible mustard seeds with \~ 2mm diameter fixed with adhesive tape in 4 to 5 specific body points to control musculoskeletal pain.

Placebo Auriculotherapy with seeds

Placebo Auriculotherapy complementary to usual drug treatment. Seeds will be used in 4 auricular points in the lobe of the ear that have no specific relation to the musculoskeletal pain in the lower limbs and with the innervation of the vagus nerve.

Group Type: PLACEBO_COMPARATOR

Placebo Auriculotherapy with seeds

Intervention Type: PROCEDURE

Roasted edible mustard seeds with \~ 2mm diameter fixed with adhesive tape at 4 points located in the auricular lobe not specific for musculoskeletal pain.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Auriculotherapy complementary to the drug therapy; Placebo Auriculotherapy complementary to usual treatment

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Ceara

OTHER

Sponsor Role: lead

Responsible Party

Bernardo Diniz Coutinho

Department of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renata N Kirkwood, doctor

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Locations

Grupo de Atenção Integral e Pesquisa em Acupuntura e Medicina Tradicional Chinesa - GAIPA

Fortaleza, Ceará, Brazil

Countries

Brazil

Other Identifiers

U1111-1193-8428

Identifier Type: -

Identifier Source: org_study_id