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Completed

NCT Number: NCT03090685

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

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 .

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Fortaleza, Ceará, 60430-160, Brazil

About this study

Objectives of the study

  • To evaluate the effectiveness of Auriculotherapy in the management of pain and functional capacity of symptomatic individuals after Chikungunya fever.
  • To evaluate the effects of Auriculotherapy on the intensity of pain, limitation of mobility, and perception of disability and physical capacity.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

True auriculotherapy with seeds

Procedure

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

Other names: Auriculotherapy complementary to the drug therapy

Placebo Auriculotherapy with seeds

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.

Other names: Placebo Auriculotherapy complementary to usual treatment

Primary outcomes

  1. Pain Numerical rating scale (NRS)

    Time frame: collected at baseline up to 2 months after therapy

    Graded scale from 0 (no pain) to 10 (worst pain imaginable) that evaluates in one-dimensional the perception of pain by asking about the average pain felt in the past seven days in the symptomatic limb.

  2. Timed Up and Go Test (TUG)

    Time frame: collected at baseline up to 2 months after therapy

    Performance-based test designed to assess functional mobility and risk of falls in frail older adults.This instrument has been associated with other to test musculoskeletal conditions.

Secondary outcomes

  1. World Health Disability Assessment Schedule (WHODAS 2.0)

    Time frame: collected at baseline up to 2 months after therapy

    Generic instrument with high internal consistency (α: 0.86), high test-retest reliability (ICC: 0.98) that evaluates deficiency and functionality based on six domains (cognition, mobility, self-care, interpersonal relations, life activity and participation).

  2. Short Physical Performance Battery (SPPB)

    Time frame: collected at baseline up to 2 months after therapy

    Test consisted of thress sub-tests that assess the functional capacity of the lower limbs, through static balance, gait speed and lower limb muscle strength.

  3. Reducing the use of pain medication

    Time frame: collected at baseline up to 2 months after therapy

    Patient self-report on the use of analgesic and anti-inflammatory drugs, by recording the dosage and type of medication.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Ceara

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 27, 2017
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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