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

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ClinicalTrials.gov Identifier: NCT03090685
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Bernardo Diniz Coutinho, Universidade Federal do Ceara

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 .


Condition or disease Intervention/treatment Phase
Chikungunya Fever Procedure: True auriculotherapy with seeds Procedure: Placebo Auriculotherapy with seeds Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, double-blind randomized controlled trial (RCT).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The sample randomization procedure will be performed by means of a computer program, which will generate a random sequence to be placed in an opaque envelope by an assistant not involved in the evaluation and treatment.
Primary Purpose: Treatment
Official Title: Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya Fever

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Auriculotherapy complementary to the drug therapy

Placebo Comparator: 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.
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.
Other Name: Placebo Auriculotherapy complementary to usual treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090685


Locations
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Brazil
Grupo de Atenção Integral e Pesquisa em Acupuntura e Medicina Tradicional Chinesa - GAIPA
Fortaleza, Ceará, Brazil, 60430-160
Sponsors and Collaborators
Universidade Federal do Ceara
Investigators
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Study Director: Renata N Kirkwood, doctor Federal University of Minas Gerais

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Responsible Party: Bernardo Diniz Coutinho, Department of Physical Therapy, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT03090685     History of Changes
Other Study ID Numbers: U1111-1193-8428
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bernardo Diniz Coutinho, Universidade Federal do Ceara:
Chikungunya Fever
Pain
Mobility Limitation
Auriculotherapy
Complementary Therapies
Physical Therapy
Additional relevant MeSH terms:
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Chikungunya Fever
Fever
Body Temperature Changes
Signs and Symptoms
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases