Comparative Study on the Effect of Auriculotherapy in the Treatment of Postoperative Pain in Outpatient Surgery: Rhizarthrosis PARALLEL COMPARATIVE STUDY RANDOMIZED AND DOUBLE-BLIND
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Assessment of pain reduction using the Numerical Rating Scale (NRS) questionnaire during the postoperative period from Day 1 to Day 3. From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions
研究概览
简要总结
Auriculotherapy has demonstrated promising potential in the management of postoperative pain. Additionally, one study reported encouraging outcomes regarding the reduction of anxiety levels among patients in primary healthcare settings. Nevertheless, further high-quality research is required to substantiate these findings and to support the integration of auriculotherapy into standardized therapeutic protocols.
The objective of this prospective, comparative, double-blind study is to assess the efficacy of auricular acupuncture in the management of postoperative pain following outpatient prosthetic surgery for rhizarthrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged over 18 years
- •Patients hospitalized for endoscopic treatment of thumb carpometacarpal osteoarthritis (rhizarthrosis)
- •Patient with no prior history of auriculotherapy sessions
- •No participation in another clinical study
- •Subject affiliated with, or beneficiary of, a social security system
- •Agrees to complete all study questionnaires
排除标准
- •Patient under 18 years of age
- •Unable to comply with medical follow-up required for the study
- •Adult subject under legal protection, guardianship, or trusteeship
- •Patient with neuropathic pain
研究组 & 干预措施
Real auriculotherapy + standard medical care group A
Real auriculotherapy + standard medical care
干预措施: outpatient prosthetic surgery for rhizarthrosis. (Procedure)
Real auriculotherapy + standard medical care group A
Real auriculotherapy + standard medical care
干预措施: real auricolothery (Other)
sham auriculotherapy + standard medical care group B
Sham auriculotherapy + standard medical care
干预措施: outpatient prosthetic surgery for rhizarthrosis. (Procedure)
sham auriculotherapy + standard medical care group B
Sham auriculotherapy + standard medical care
干预措施: sham auriculotherapy (Other)
结局指标
主要结局
Assessment of pain reduction using the Numerical Rating Scale (NRS) questionnaire during the postoperative period from Day 1 to Day 3. From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions
时间窗: Day 1 to Day 3
The Numerical Rating Scale (NRS) is a validated, unidimensional tool used to assess pain intensity. Patients are asked to rate their pain by selecting a number that best reflects its severity. Valeur minimale : 0 - corresponds to "no pain". Valeur maximale : 10 - corresponds to "the worst pain imaginable". Interprétation générale : 0 : No pain 1-3 : Mild pain 4-6 : Moderate pain 7-10 : Severe pain
Assessment of pain reduction using the Numerical Rating Scale (NRS) questionnaire during the postoperative period from Day 1 to Day 3. From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions
时间窗: Day 1 to Day 3
The Numerical Rating Scale (NRS) is a validated, unidimensional tool used to assess pain intensity. Patients are asked to rate their pain by selecting a number that best reflects its severity. Valeur minimale : 0 - corresponds to "no pain". Valeur maximale : 10 - corresponds to "the worst pain imaginable". Interprétation générale : 0 : No pain 1-3 : Mild pain 4-6 : Moderate pain 7-10 : Severe pain
次要结局
- Assessment of postoperative anxiety reduction between the two groups using the State-Trait Anxiety Inventory (STAI) score.(At baseline and at one-month postoperative follow-up)
- Assessment of the onset of neuropathic pain using the DN4 questionnaire during follow-up.(At baseline and at one-month postoperative follow-up)
- Assessment of patient satisfaction using the CGI-C scale.(at one-month postoperative follow-up)
- Assessment of the onset of neuropathic pain using the DN4 questionnaire during follow-up.(At baseline and at one-month postoperative follow-up)
- Assessment of analgesic consumption (number, name, and analgesic step) from the end of the hand regional anesthesia until Day 3, and again at one month(from the end of the hand regional anesthesia until Day 3, and again at one month postoperative follow-up)
- Assessment of patient satisfaction using the CGI-C scale.(at one-month postoperative follow-up)
- Assessment of postoperative anxiety reduction between the two groups using the State-Trait Anxiety Inventory (STAI) score.(At baseline and at one-month postoperative follow-up)