Clinical Trial: Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
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 Summary:
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 a
Sponsor: Universidade Federal do Ceara
Current Primary Outcome:
- 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.
- 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.
Original Primary Outcome:
- Numerical rating scale of pain (NRS) [ Time Frame: Measured at baseline and 1, 2 months after treatment initiation ]A graded scale of 0 (no pain) to 10 (worst pain imaginable) that evaluates in a one-dimensional way the perception of pain, through the questioning about the average pain that felt in the last 7 days in the most symptomatic member.
- Timed Up and Go Test (TUG) [ Time Frame: Measured at baseline and 1, 2 months after treatment initiation ]Performance-based test designed to assess functional mobility and risk of falls in frail older adults, and has been used in conjunction with other tests for musculoskeletal conditions.
Current Secondary Outcome:
- 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).
- 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.
- 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.
Original Secondary Outcome:
- World Health Disability Assessment Schedule (WHODAS 2.0) [ Time Frame: Measured at baseline and 1, 2 months after treatment initiation ]Generic instrument with high internal consistency (α: 0.86), high test-retest reliability (ICC: 0.98) evaluating deficiency and functionality according to six domains (cognition, mobility, self-care, interpersonal relations, life activity and participation).
- Short Physical Performance Battery (SPPB) [ Time Frame: Measured at baseline and 1, 2 months after treatment initiation ]Test consisting of 3 sub-tests that assess the functional capacity of the lower limbs, through static balance, gait speed and lower limb muscle strength.
- Reduction of pain medication use [ Time Frame: Measured at baseline and 1, 2 months after treatment initiation ]Evaluated by self-report of the patient on the use of analgesic and anti-inflammatory, recording the dose and type of medication.
Information By: Universidade Federal do Ceara
Dates:
Date Received: March 14, 2017
Date Started: May 5, 2017
Date Completion: February 1, 2018
Last Updated: May 9, 2017
Last Verified: May 2017
