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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03090685
Enrollment
50
Registered
2017-03-27
Start date
2017-05-05
Completion date
2017-11-01
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chikungunya Fever

Keywords

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

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.

Interventions

PROCEDURETrue 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.

PROCEDUREPlacebo 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.

Sponsors

Universidade Federal do Ceara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Pain Numerical rating scale (NRS)collected at baseline up to 2 months after therapyGraded 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)collected at baseline up to 2 months after therapyPerformance-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

MeasureTime frameDescription
World Health Disability Assessment Schedule (WHODAS 2.0)collected at baseline up to 2 months after therapyGeneric 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)collected at baseline up to 2 months after therapyTest 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 medicationcollected at baseline up to 2 months after therapyPatient self-report on the use of analgesic and anti-inflammatory drugs, by recording the dosage and type of medication.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026