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

NCT03090685 | Completed DMC

• 1 other identifier: U1111-1193-8428
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chikungunya Fever

Keywords

Chikungunya Fever; Pain; Mobility Limitation; Auriculotherapy; Complementary Therapies; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• Pain Numerical rating scale (NRS)

  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.

  collected at baseline up to 2 months after therapy

• Timed Up and Go Test (TUG)

  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.

  collected at baseline up to 2 months after therapy

Secondary Outcomes (3)

• World Health Disability Assessment Schedule (WHODAS 2.0)

  collected at baseline up to 2 months after therapy

• Short Physical Performance Battery (SPPB)

  collected at baseline up to 2 months after therapy

• Reducing the use of pain medication

  collected at baseline up to 2 months after therapy

Study Arms (2)

True auriculotherapy with seeds

EXPERIMENTAL

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

Placebo Auriculotherapy with seeds

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Auriculotherapy complementary to the drug therapy

True auriculotherapy with seeds

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.

Also known as: Placebo Auriculotherapy complementary to usual treatment

Placebo Auriculotherapy with seeds

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Federal do Ceara: lead

Study Sites (1)

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

Fortaleza, Ceará, 60430-160, Brazil

Location

MeSH Terms

Conditions

Chikungunya Fever; Pain; Mobility Limitation

Interventions

Seeds

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Renata N Kirkwood, doctor

  Federal University of Minas Gerais

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Therapy

Model Details: Prospective, double-blind randomized controlled trial (RCT).

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 27, 2017
• Study Start: May 5, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)