Effects of Auriculotherapy on Pain and Functional Capacity of Individuals With Chikungunya Fever
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Timed Up and Go Test (TUG)
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: True auriculotherapy with seeds (Procedure)
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.
干预措施: Placebo Auriculotherapy with seeds (Procedure)
结局指标
主要结局
Timed Up and Go Test (TUG)
时间窗: 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.
Pain Numerical rating scale (NRS)
时间窗: 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.
次要结局
- Reducing the use of pain medication(collected at baseline up to 2 months after therapy)
- 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)
研究者
Bernardo Diniz Coutinho
Department of Physical Therapy
Universidade Federal do Ceara