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

Primary Purpose

Chikungunya Fever

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
True auriculotherapy with seeds
Placebo Auriculotherapy with seeds
Sponsored by
Universidade Federal do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chikungunya Fever focused on measuring Chikungunya Fever, Pain, Mobility Limitation, Auriculotherapy, Complementary Therapies, Physical Therapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

True auriculotherapy with seeds

Placebo Auriculotherapy with seeds

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

World Health Disability Assessment Schedule (WHODAS 2.0)
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).
Short Physical Performance Battery (SPPB)
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.
Reducing the use of pain medication
Patient self-report on the use of analgesic and anti-inflammatory drugs, by recording the dosage and type of medication.

Full Information

First Posted
March 14, 2017
Last Updated
October 9, 2018
Sponsor
Universidade Federal do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT03090685
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Fever
Keywords
Chikungunya Fever, Pain, Mobility Limitation, Auriculotherapy, Complementary Therapies, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, double-blind randomized controlled trial (RCT).
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
True auriculotherapy with seeds
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Auriculotherapy with seeds
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
True auriculotherapy with seeds
Other Intervention Name(s)
Auriculotherapy complementary to the drug therapy
Intervention Description
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
Intervention Name(s)
Placebo Auriculotherapy with seeds
Other Intervention Name(s)
Placebo Auriculotherapy complementary to usual treatment
Intervention Description
Roasted edible mustard seeds with ~ 2mm diameter fixed with adhesive tape at 4 points located in the auricular lobe not specific for musculoskeletal pain.
Primary Outcome Measure Information:
Title
Pain Numerical rating scale (NRS)
Description
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.
Time Frame
collected at baseline up to 2 months after therapy
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
collected at baseline up to 2 months after therapy
Secondary Outcome Measure Information:
Title
World Health Disability Assessment Schedule (WHODAS 2.0)
Description
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).
Time Frame
collected at baseline up to 2 months after therapy
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
collected at baseline up to 2 months after therapy
Title
Reducing the use of pain medication
Description
Patient self-report on the use of analgesic and anti-inflammatory drugs, by recording the dosage and type of medication.
Time Frame
collected at baseline up to 2 months after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata N Kirkwood, doctor
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
Facility Information:
Facility Name
Grupo de Atenção Integral e Pesquisa em Acupuntura e Medicina Tradicional Chinesa - GAIPA
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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