ABSTRACT
BACKGROUND: Lumbar disc herniation (LDH) is a common and frequently occurring disease in clinics. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma's bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. The aim of this trial is to evaluate the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy in the treatment of LDH low back pain. METHODS/DESIGN: The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma's bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156). Patients in each group will receive treatment every day, 6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analog scale(VAS) at baseline, after 6 times of treatment, end of treatment, and follow-up. The secondary outcomes will include Oswestry disability indexes (ODI), modified Japanese Orthopaedic Association low back pain (M-JOA) score, serum ß-endorphin (ß-EP), and serum substance P (SP). ß-EP and SP, as well as safety evaluation indexes (routine blood, liver, and kidney function and electrocardiogram), will be measure at baseline and after the end of treatment. The number, nature, and severity of adverse events will be recorded. DISCUSSION: The results of the trial will compare the efficacy of low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and the acupuncture group and will be expected to make a systematic and objective evaluation of the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy. TRIAL REGISTRATION: ChiCTR2000038725 . Registered on 29 September 2020.
Subject(s)
Acupuncture Therapy , Intervertebral Disc Displacement , Low Back Pain , Moxibustion , Sciatica , Acupuncture Therapy/methods , Humans , Intervertebral Disc Displacement/complications , Intervertebral Disc Displacement/diagnosis , Intervertebral Disc Displacement/therapy , Low Back Pain/diagnosis , Low Back Pain/therapy , Moxibustion/adverse effects , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Sciatica/diagnosis , Substance P , beta-EndorphinABSTRACT
OBJECTIVE: To compare the diagnostic performance of prospective electrocardiogram (ECG)-triggered computed tomography coronary angiography (CTCA) versus retrospective ECG-gated CTCA. METHODS: Patients with suspected coronary artery disease divided into two groups which underwent 64-slice CTCA with prospective ECG-triggered or retrospective ECG-gated scanning (n = 100 each, HR < or = 65 bpm). Multi-planar reconstruction (MPR), curved-planar reconstruction (CPR), maximum intensity projection (MIP) and volume rendering (VR) were made to demonstrate the coronary arteries. The image quality was defined as excellent, good and poor by motion and stair-step artifacts. Individual radiation exposure dose was estimated from the dose-length product. RESULTS: The mean effective radiation dose of prospective ECG-triggered CTCA [(2.81 +/- 0.48) mSv] was significantly lower than that of retrospective ECG-gated CTCA [(10.16 +/- 1.09) mSv, P < 0.01]. Segments of diagnostic image quality (95.2%, 1165/1224) and non-diagnostic coronary segments (4.8%, 59/1224) in prospective ECG-triggered group were similar as those of retrospective ECG-gated group (94.1%, 1186/1261 and 5.9%, 75/1261, all P > 0.05). CONCLUSION: Though the radiation exposure dose required is significantly lower, the diagnostic performance of prospective ECG-triggered 64 slice CTCA is comparable with that of retrospective ECG-gated 64 slice CTCA on patients with stable heart rates up to 65 bpm.
