Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA
研究概览
简要总结
This study aims to see whether acupuncture can help fibromyalgia patients by giving them acupuncture treatment and seeing whether acupuncture helps enhance the effects of an opioid.
详细描述
The investigator hypothesizes that traditional acupuncture (TA) enhances binding of the MOR receptor which will then enhance the pain-reducing effects of opioids compared to sham acupuncture (SA). The investigator will test the hypothesis by giving participants a validated Brief Pain Inventory to complete during the pre-therapy opioid challenge and one week after TA or SA therapy is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 18 - 80 years old
- •have been diagnosed with Fibromyalgia for more than 6 months
- •Are already using chronic, continuous opioid therapy, including but not limited to the use of Hydrocodone (Norco), Oxycodone (Percocet), morphine, methadone or Tylenol #3 daily
- •Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)
排除标准
- •Are younger than 18 or older than 80 years old
- •Have been diagnosed with a Substance Use Disorder (SUD)
- •Have an active litigation or worker's compensation case
- •Have an active mental health diagnosis, such as bipolar disorder, psychosis, or suicidal ideation
- •Are prescribed and actively using low dose Naltrexone . Have tried acupuncture in the last 6 months
研究组 & 干预措施
Traditional acupuncture
During TA, 9 acupuncture needles (Seirin 0.25 · 50 mm) are inserted at GV20,earShenmen,LI4,LI11,SP6,LR3,GB34,and bilateral ST 36. Needle insertion depth is approximately 2 cm for all TA points except for DU 20 and ear Shenmen, which have shallower insertion depths. All needles below the neck level are manually manipulated to elicit De Qi sensations.
干预措施: Traditional Acupuncture (Procedure)
Sham acupuncture
SA participants experience a non-skin penetrating pricking sensation at 9 non-acupuncture point locations, sham intervention did not penetrate the skin and was designed to not elicit De Qi. somatosensory component generated by this procedure would be likely to be less than the skin penetrating-TA protocol that elicited De Qi. The sham locations were within similar body locations as the TA points; however, the SA location is not on known acupuncture points or meridians.
干预措施: Sham Acupuncture (Procedure)
结局指标
主要结局
Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA
时间窗: Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).
We hypothesize that patients randomized to TA treatment will have a statistically greater change in pain after the final opioid challenge compared to the initial opioid challenge, as compared to patients randomized to SA treatment(p-value set at 0.05).
次要结局
- Change in FIQ(Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).)
研究者
Ariana M. Nelson
MD, Associate Clinical Professor
University of California, Irvine