Acupuncture for Reduction of Inflammation in Thyroid and Parathyroid Surgery: Randomized, Prospective Double Blind Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual Acuity Score (VAS)
研究概览
简要总结
This study is being done because the investigators wish to study ways to improve recovery after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the body's attempt to protect itself and to start the healing process. Some surgical complications are related to the body's natural inflammatory response. Although mainly a healing response, inflammation can also have side effects which delay recovery. The investigators wish to determine the effect of acupuncture on post-operative surgical pain. An increase in pain after surgery can cause distress for patients. Acupuncture is an alternative medicine methodology originating in China that treats patients by manipulating thin, solid needles that have been inserted into acupuncture points in the skin. Acupuncture has been used for the reduction of pain. The investigators would like to see if acupuncture during surgery can provide a lower level of pain, reduced pain medication requirement, and a lower incidence of nausea and vomiting.
详细描述
Acupuncture has traditionally been used in Asia and is increasingly popular in Western countries to treat a variety of conditions (1). In recent years, acupuncture is widely used to assist in improving pain and inflammatory diseases (2). However, the mechanisms associated with these treatments that influence the immune system are not yet understood.
Cytokines like interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) are proposed to be proximal mediators in the early stages of inflammation. They modulate many of the early inflammatory response that is induced by tissue injury, infection, or an immune stimulus (3, 4). Although the response is a critical first line of defense against pathogens, when the inflammatory reaction is uncontrolled, it can cause more damage to the host than the initial stimulus. TNF-α is a pro-inflammatory cytokine that is very effective in local and systemic inflammations (5). In addition, TNF-α increases the production of other inflammatory cytokines such as IL-1β, IL-6, and interleukin-18 (IL-18) during the inflammatory process. Therefore, it initially brings infections under control, produces coagulation in the damaged tissue, and stimulates tissue improvement. An excessive increase of TNF-α level causes an extreme immune reaction and contributes to the development of atherosclerosis, shock, endotoxemia, and chronic inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, and inflammatory bowel disease (5-7). Yim and colleagues reported a decrease in increased serum TNF-α, IL-6, and interferon gamma levels by arthritis as a result of electroacupuncture treatment (9). In a rat model for ulcerative colitis, acupuncture inhibited the expression of IL-1β and IL-6 (10). It has been reported that acupuncture significantly reduces complete Freund's adjuvant-induced hind paw edema and mouse air pouch inflammation (11, 12). Acupuncture could also improve immune dysfunction after surgical stress both in human and animals (13, 14).
Some cytokines are pro-inflammatory, but others are anti-inflammatory (3). The anti-inflammatory interleukins comprise interleukine-4 (IL-4) and interleukine-10 (IL-10) and these are considered as mediating the down-regulation of immune-inflammatory conditions. Acupuncture for treatment of the ulcerative colitis rats is possibly related with the decrease of IL-1β, a pro-inflammatory cytokine, and the increase of IL-4, an anti-inflammatory cytokine (15).
Therefore, it is reasonable to expect that the protective action of acupuncture is exerted by the modulation of pro- and anti-inflammatory cytokines. The restoration of balance between pro- and anti-inflammatory cytokines by acupuncture gives into the mechanisms underlying the immune-modulation effect of acupuncture.
Inflammation is associated with pain hypersensitivity that is produced by the release of inflammatory mediators. The pro-inflammatory cytokines play an essential role in pain sensitization (16). The peripheral effects of these cytokines on sensitizing nociceptors have been well documented (16). Post-operative surgical pain can cause significant physiologic and psychologic distress for patients. An increase in pain duration and intensity after surgery can contribute to a variety of complications, including delayed ambulation, pulmonary and thromboembolic complications, increased length of hospital stay, and generalized distress and anxiety. Effective post-surgical pain relief requires a multidisciplinary effort and influences patients' satisfaction with care and successful outcomes (17). Acupuncture has been used for a long time for the reduction of pain. In light of these factors, the use of acupuncture that may allow a reduction in the dosage of conventional analgesics is highly valuable because it can lower the incidence of possible adverse effects. Several trials have demonstrated that patients receiving acupuncture prior to surgery have a lower level of pain, reduced opioid requirement, a lower incidence of post-operative nausea and vomiting, and lower sympatho-adrenal responses (18). The local release of β-endorphin could be responsible for the analgesic effect. β-endorphin may be interacting with cytokines to reduce pain and acupuncture may amplify the interaction between β-endorphin and cytokines.
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)
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
- •Not currently pregnant or beast feeding
- •American Society of Anesthesiologists physical status of 1, 2, 3 as determined by your anesthesiologist
- •Patients have a working telephone
排除标准
- •Uncontrolled high blood pressure (systolic > 180 mm Hg (millimeters of mercury), diastolic>110 mm Hg
- •Heart block >than first degree
- •Cardiac muscle is at risk for injury
- •not English speaking
- •Acupuncture within the last 30 days
- •If you have taken ibuprofen, advil aleve, motrin or aspirin with 5 days of the scheduled surgery.
- •Prior history of drug or alcohol dependence
- •If you are unable to feed, dress or bathe yourself
- •If your breathing tube is not removed prior to leaving the operating room.
结局指标
主要结局
Visual Acuity Score (VAS)
时间窗: arrival in PACU to 2 hours post operatively
VAS is a self reported pain scale with a score ranging from 0 to 10. 0= no pain, 10=worst pain possible. Multiple pain sacores were recorded. single value is reported by average
Morphine Equivalent
时间窗: PACU, day 1 , day 2, day 3
equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.
Reduced Pain Medication Requirement
时间窗: amount of pain medication provided in PACU
analgesia provided in Post Anesthesia Care Unit PACU)
Pain Levels
时间窗: PACU, day 1 , day 2, day 3
Visual Acuity scale 0=no pain 10= worst pain possible
次要结局
- Serum Insulin Level(preoperative and postoperative)
- Tumor Necrosis Factor (TNF)(preoperatively-intraoperatively-postoperatively)
- iNTERLEUKIN (IL-2 and IL-4)(Preoperatively-intraoperatively-postoperatively)
- (ACTH )Adrenocorticotropic Hormone(serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACU)
- Cortisol(prior to surgical incision, 1 hour following incision, after arrival in PACU)
- Morphine Equivalent (mg)(PACU arrival to 2 hours post op)
- Morphine Equivalent(PACU to 2 hours post op)
- Modified Quality of Recovery Scale(Day 1, 2, 3)
- IL-10(Preoperatively-intraoperatively-postoperatively)
- Glucose(serum glucose from baseline to PACU arrival)
- IL-6(Preoperatively-intraoperatively-postoperatively)
- TGFB1(Preoperatively-intraoperatively-postoperatively)
