Controlled, Double-blind, Randomized Clinical Trial of the Use of Laser Auriculotherapy for the Treatment of Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 主要终点
- Algometry
研究概览
简要总结
Controlled, double-blind, randomized clinical trial
Primary endpoint:
To demonstrate the superiority of Laser French Auriculotherapy (AFL) in relieving pain in patients with low back pain after a single session.
Primary outcome:
The increase in pain tolerance will be assessed by Algometry of the affected muscles
Secondary endpoints:
To determine the duration of the analgesic effect of AFL. To determine the increase in pain tolerance through Algometry
Secondary outcomes:
The improvement in pain after treatment with daily measurements for 7 days will be assessed using the TotPar Scale The reduction in pain will be assessed using the Sum of Pain Intensity Difference (SPID) Scale by comparing the differences in scores observed between pre-treatment and post-treatment with daily measurements for 7 days Reduction in the 10-point visual analogue scale for pain. Need for rescue medication
Safety endpoint:
Evaluate adverse events that occurred during the trial, after signing the Informed Consent Form (ICF).
Safety outcomes:
Evaluate safety through data obtained in clinical and physical assessments, and in specific assessments of the clinical trial (immediately after signing the ICF).
Evaluate the rate of occurrence of non-serious and serious adverse events, related and unrelated to the treatment groups throughout the clinical trial.
详细描述
Trial Population Patients with primary or secondary low back pain, aged between 18 and 65 years, who attended the Institute of Orthopedics and Traumatology of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (IOTHCFMUSP) acupuncture clinic.
Trial Design
Clinical, superiority, double-blind, randomized trial with two parallel groups:
- Test Group: Will receive an auricular laser application at the points indicated for this treatment and that are active (through a point locator device) using a 660 nanometer red laser with the appropriate Nogier frequency, 2 joules per point. In addition, an infrared laser will be applied at the frequency
- Comparator group: will receive a touch on the skin at the same points with a non-laser emitting pen.
Both patients will wear opaque protective glasses and, therefore, will not be able to observe the application. The patient must continue to use the prescribed medications.
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 procedure will be performed by an unblinded investigator. The patient will be blinded by means of an eye shield that blocks his/her vision. The assessment of pain scales and algometry will be performed by a blinded investigator.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant capable of understanding and performing all procedures and instructions described in the Informed Consent Form approved by the Research Ethics Committee;
- •Participants of both sexes, aged between 18 and 65 years (inclusive);
- •Participants diagnosed with low back pain who are in pain at the time of the assessment
排除标准
- •Any clinical observation finding (clinical/physical evaluation) that is interpreted by the investigating physician as a risk to participation in the clinical trial;
- •Patient with a deforming lesion on the ear
- •Patient with a tattoo covering any of the points selected for treatment
- •Patients using ear expanders on the side to be treated
- •Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Brazilian National Health Council Resolution 251, of August 7, 1997), unless the investigator believes that there may be direct benefit to the same.
结局指标
主要结局
Algometry
时间窗: 1 hour after intervention
Increase in pain tolerance will be assessed by Algometry of the affected muscles
次要结局
- TotPar Scale(1 week after intervention)
- SPID Scale(1 week after intervention)
- Visual analogue scale(1 week after intervention)
- Rescue medication(1 week after intervention)
- Adverse Events(1 week after intervention)
研究者
Marcelo Neubauer de Paula
Guest Professor at the IOTHCFMUSP Acupuncture Center
University of Sao Paulo