Acupuncture in patients with a vertebral compression fracture: a protocol for a randomized, controlled, pilot clinical trial.

OBJECTIVES: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. METHODS: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision(TM) system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial.

BACKGROUND: Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis. METHODS/DESIGN: The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation). DISCUSSION: This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis. TRIAL REGISTRATION: This trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.

Epidural catheterization with a subcutaneous injection port for the long-term administration of opioids and local anesthetics to treat zoster-associated pain -a report of two cases-.

Continuous epidural analgesia has been used for decades to treat acute herpes zoster pain and to prevent postherpetic neuralgia. However, many technical problems can arise during chronic treatment with epidural medications. These complications include catheter dislodgement, infection, injection pain, leakage, and occlusion. Epidural catheter placement utilizing subcutaneous injection port implantation has gained widespread acceptance as a method to overcome such complications. The technique reduces the risk of infection, the most feared complication, compared to the use of a percutaneous epidural catheter. Herein, we present 2 cases in which the continuous thoracic epidural administration of opioids and local anesthetics through an implantable subcutaneous injection port for over 2 months successfully treated zoster-associated pain without any technique- or medication-related complications in patients with risk factors for epidural abscess.

Bispectral index monitoring correlates with the level of consciousness in brain injured patients.

BACKGROUND: In general, measuring the level of consciousness in neurological patients is important. To assess the patient's mental status, the Glasgow Coma Scale (GCS) and the level of consciousness (drowsiness, stupor, and coma) have been used in clinical situations. The aim of the present study was to identify the correlation between bispectral index (BIS) and level of consciousness in brain injured patients. METHODS: Eighty-nine adult patients of both sexes were included in the study. A blinded observer evaluated the mental status (GCS and level of consciousness) of a patient who is admitted in intensive care unit with brain injury, while an investigator noted the patient's BIS. The BIS was measured using a BIS monitor, Model A-3000 vista™ with Sensor Bis quatro™ (Aspect Medical Systems, Norwood, USA). A Spearman's rank correlation coefficient was used to determine if the level of consciousness correlated with the BIS. RESULTS: In 89 patients, the BIS was found to be significantly correlated with the level of consciousness (r = 0.723, P < 0.01) and GCS (r = 0.646, P < 0.01). The BIS values increased with an increasing level of consciousness. Mean BIS values of coma, semicoma, stupor and drowsiness were 0.14 ± 0.23, 38.9 ± 18.0, 60.3 ± 14.5, and 73.6 ± 16.5, respectively. CONCLUSIONS: In the present study, a significant correlation existed between level of consciousness and BIS. These findings suggest that BIS may be used for assessing the level of consciousness in brain injured patients. However, the scatter of BIS values for any level of consciousness limited the worth of BIS in predicting mentality except in coma patients.