Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- SF-36P
研究概览
简要总结
This unblinded Phase II clinical trial will test the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners will have had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness will be randomized to either six months of biweekly acupuncture treatments (group 1, n=100) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=100). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).
详细描述
Gulf War Illness (GWI), or chronic multisymptom illness (CMI), is a complex illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain, which are unexplained by physical and laboratory examinations. There is no standard of care treatment for this syndrome at this time. First defined by the Centers for Disease Control and Prevention (CDC) after the first Gulf War, it is commonly seen with a highly individualistic presentation, associated with clusters of symptoms and co-morbid medical diagnoses, including chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome, arthralgia, digestive complaints, and mood-related psychiatric disorders, including depression, posttraumatic stress disorder (PTSD), and other anxiety disorders. It has been shown to be remarkably stable at 5- and 10- year follow-ups. Of the 700,000 service personnel deployed to the Persian Gulf, 100,000 veterans of the first Gulf War (Operation Desert Shield/Storm, years 1990-1991) have presented with medical complaints through clinical and registry programs. GWI is twice as prevalent in deployed veterans, and seen in 15% of non-deployed veterans.
CMI symptoms have been studied in cohorts of veterans in the United Kingdom, Canada, and Australia. The etiology of CMI is still unknown, and hypotheses involving exposures to vaccines, medications, pesticides, chemical munitions, and inhalation of depleted uranium dust and smoke from burning oil fields, have all been investigated inconclusively. Stress plays a likely role in the etiology of other multisymptom illnesses, such as irritable bowel syndrome (IBS), multiple chemical sensitivity and chronic headache. It is likely that veterans of the current war in Iraq and Afghanistan are exposed to similar deployment stressors and will benefit from an investigation of CMI and its treatment.
Acupuncture is an evidence-based, nonpharmacologic treatment commonly used for many symptoms affecting veterans and active military personnel, including pain. Acupuncture has shown efficacy for a variety of painful musculoskeletal disorders, as a treatment for both acute and chronic pain after amputation in military contexts, and in the treatment of related comorbidities such as fatigue, state, trait and situational anxiety, and depression. Acupuncture has shown effectiveness and is used in the Veterans Health Administration (VHA) and covered by Medicare for some conditions.
The L Conboy lab has completed multiple successful acupuncture trials in areas such as Irritable Bowel Syndrome, Carpel Tunnel Syndrome, and pelvic pain. Most recently the study team successfully completed a 3.5-year Congressionally Directed Medical Research Program (CDMRP) randomized controlled trial (RCT) "The Effectiveness of Acupuncture in the Treatment of Gulf War Illness". In that study, veterans chose a trained study acupuncturist in a location convenient to them. These community-based acupuncturists provided personalized acupuncture in a therapeutically informed dose. In the robust sample (n=104), investigators found a clinically and statistically significant improvement in pain after 2 months of treatment. After 6 months of treatment McGill Pain Scale values showed a 6-point improvement (p<=0.001), and the physical component of the SF-36 (SF-36P) showed a 9-point improvement (p<=0.003). Investigators also found statistically and clinically improvements in: the severity of veterans' self-reported main (p<0.01) and secondary (p<0.009) complaints as measured by the patient-centered Measure Your Medical Outcomes Profile (MYMOP) outcome measure, self-reported overall health from the SF-36P (p<0.007), and fatigue (p<0.05) based on the Multidimensional Assessment of Fatigue. Patient satisfaction with care and confidence in treatment was also very high (95% rated satisfied and confident). In addition, investigators found that the theoretically informed dose (2 sessions per week for 6 months) provided more relief for pain and poor function than did the comparison dose of one session per week, and that over 95% of symptom improvement for pain was maintained at 5-year follow up. Acupuncture at a sufficient dose is one of the only treatments found to be effective in improving pain and function in this hard-to-treat population while also addressing other symptoms in the patient's biopsychosocial presentation. Other high-quality science has shown that dosage is important for acupuncture treatment, and that treatment effects can persist long after acupuncture treatment has ended.
While this clinical data is very promising, equally important is furthering the understanding of the mechanisms of Gulf War Illness and successful treatments. Investigators conducted blood biomarker analyses using the collected blood samples from the parent trial, including collaborations with the Boston Biorepository, Recruitment and Integrative Network (BBRAIN) consortium at Boston University. Investigators found a number of interesting contrasts including significantly altered ether lipid metabolism in GWI, and that acyl-carnitine molecules are decreased in GWI, in agreement with previous reports. More recently, in collaboration with anti-aging researchers at Berkeley, investigators have found that acupuncture at the proper dose shifts the protein signature of GWI veteran to resemble a younger state (see below). In order to further elucidate the mechanisms underlying both GWI and successful treatments, the collection of blood biomarkers will be augmented by collection of physiological biomarkers potentially implicated in GWI symptoms.
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 (Investigator, Outcomes Assessor)
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
- •Deployed to the Gulf Theater of operations (as defined by 38 CFR 3.317, includes Iraq, Kuwait, Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace above all of these locations) between August 1990 and the present date
- •Have at least 2 of the following symptoms from the 3 CDC clusters of symptom that have lasted for more than 6 months. Each symptom cluster must be characterized as mild-moderate or severe, with at least one symptom in each cluster required to be severe. The clusters are:
- •A. Fatigability: fatigue 24 hours or more after exertion B. Mood and Cognition: feeling depressed; feeling irritable; difficulty thinking or concentrating; feeling worried, tense, anxious; problems finding words; or problems getting to sleep C. Musculoskeletal: joint pain or muscle pain
排除标准
- •Currently enrolled in another clinical trial
- •Have another disease that likely could account for the symptoms, as determined by our Medical Monitor
- •Severe psychiatric illness (in the last 2 years psychiatric hospitalization, suicidal attempt, alcohol or substance abuse, use of antipsychotic medication) as measured by the Primary Care Evaluation of Mental Disorder (Prime MD).
- •Unable to complete the protocol on based on the evaluation of the Medical Monitor.
研究组 & 干预措施
Bi-weekly acupuncture treatment
Bi-weekly acupuncture treatment
干预措施: Acupuncture (Device)
Wait list
Wait list for 2 months followed by weekly acupuncture for 4 months
干预措施: Acupuncture (Device)
结局指标
主要结局
SF-36P
时间窗: 6 months
Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.
次要结局
未报告次要终点
研究者
Lisa J Taylor-Swanson
Principal Investigator, PhD
University of Utah
