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).
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
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.
Parallel
Acupuncture
DeviceSterile insertive needles are applied by licensed, experienced practitioners.
SF-36P
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.
Blood Draw
Blood draws will be used to examine levels of selected markers of inflammation, stress, and immune function. The units of measure would be relative to control, baseline or untreated. The following proteins will be evaluated: TRAIL-R1 (Tumor necrosis factor-Related Apoptosis-Inducing Ligand Recombinant protein 1); IL-16 (Interleukin 16) TIMP-1 (Tissue Inhibitor of MetalloProteinases-1); IL-15Ra (Interleukin 15 R alpha); CD27 (also known as Tumor necrosis factor receptor superfamily member 7 (TNFRSF7)); APJ (apelin receptor); SMAD5 (mothers against decapentaplegic homolog 5); uPAR (urokinase plasminogen activator surface receptor); FADD (Fas-associated death domain); MFGE8 (Milk fat globule epidermal growth factor 8); ICAM-1 (Intercellular adhesion molecule 1); TNFRSF27 (tumor necrosis factor receptor superfamily member 27); CCL25 (Chemokine ligand 25); TGFbR2 (transforming growth factor beta receptor 2); TLR4 (tool-like receptor 4)
McGill Pain Scale
The McGill Pain scale is perhaps the most recognized and utilized pain measurement device across a range of ailments. This 15-item measure asks participants to describe the quality of their pain using various different descriptors (73). The McGill pain scale is 0-60 range, where the worse the pain the higher the number.
Heart rate variability (HRV)
Signs and symptoms of autonomic dysfunction, including changes in heart rate variability (HRV), have been demonstrated among veterans diagnosed with GWI. Acupuncture has also demonstrated an impact the autonomic nervous system by effecting a shift away from sympathetic dominance and toward parasympathetic dominance. So, we propose to measure HRV parameters as a physiological biomarker of treatment effect. Specifically, the team will gather the following HRV data: heart rate (HR); respiratory rate (RR); standard deviation of normal-to-normal intervals (SDNN); root mean square of successive differences (RMSSD); pNN50 (percentage of consecutive normal sinus intervals that differ by more than 50 milliseconds); VLF (band of rhythms with periods between 25 and 300 s); LF (band of rhythms with periods between 7 and 25 s); any heart failure (HF); LF/HF (ration of low frequency to high frequency); and total power. HRV data will be extracted continuously from Fitbits worn by participants.
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University of Utah
Lead sponsor
United States Department of Defense
Collaborator
University of California, Berkeley
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
