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      Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic Neck Pain: A Randomized, Double-Blind, Controlled Trial

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          Abstract

          Study Design: A randomized, double-blind, active-controlled trial.

          Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain.

          Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain.

          Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone.

          The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight.

          Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up.

          Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.

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          Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome

          Background Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS). Methods Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47±18 with IBS diagnosed by Rome III criteria and with a score ≥150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as “placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes” or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL). Findings Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2±1.0 vs. 4.0±1.1, p<.001) and at 21-day endpoint (5.0±1.5 vs. 3.9±1.3, p = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p = .008 and p = .03) and adequate relief (IBS-AR, p = .02 and p = .03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (p = .08). Conclusion Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent. Trial Registration ClinicalTrials.gov NCT01010191
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            The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.

            Best evidence synthesis. To undertake a best evidence synthesis of the published evidence on the burden and determinants of neck pain and its associated disorders in the general population. The evidence on burden and determinants of neck has not previously been summarized. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders performed a systematic search and critical review of literature published between 1980 and 2006 to assemble the best evidence on neck pain. Studies meeting criteria for scientific validity were included in a best evidence synthesis. We identified 469 studies on burden and determinants of neck pain, and judged 249 to be scientifically admissible; 101 articles related to the burden and determinants of neck pain in the general population. Incidence ranged from 0.055 per 1000 person years (disc herniation with radiculopathy) to 213 per 1000 persons (self-reported neck pain). Incidence of neck injuries during competitive sports ranged from 0.02 to 21 per 1000 exposures. The 12-month prevalence of pain typically ranged between 30% and 50%; the 12-month prevalence of activity-limiting pain was 1.7% to 11.5%. Neck pain was more prevalent among women and prevalence peaked in middle age. Risk factors for neck pain included genetics, poor psychological health, and exposure to tobacco. Disc degeneration was not identified as a risk factor. The use of sporting gear (helmets, face shields) to prevent other types of injury was not associated with increased neck injuries in bicycling, hockey, or skiing. Neck pain is common. Nonmodifiable risk factors for neck pain included age, gender, and genetics. Modifiable factors included smoking, exposure to tobacco, and psychological health. Disc degeneration was not identified as a risk factor. Future research should concentrate on longitudinal designs exploring preventive strategies and modifiable risk factors for neck pain.
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              Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain.

              To examine the psychometric properties including test-retest reliability, construct validity, and minimum levels of detectable and clinically important change for the Neck Disability Index (NDI) and the numeric rating scale (NRS) for pain in a cohort of patients with neck pain. Single-group repeated-measures design. Outpatient physical therapy (PT) clinics. Patients (N=137) presenting to PT with a primary report of neck pain. Not applicable. All patients completed the NDI and the NRS at the baseline examination and at a follow-up. At the time of the follow-up, all patients also completed the global rating of change, which was used to dichotomize patients as improved or stable. Baseline and follow-up scores were used to determine the test-retest reliability, construct validity, and minimal levels of detectable and clinically important change for both the NDI and NRS. Test-retest reliability was calculated using an intraclass correlation coefficient (ICC) (NDI ICC=.50; 95% confidence interval [CI], .25-.67; NRS ICC=.76; 95% CI, .51-.87). The area under the curve was .83 (95% CI, .75-.90) for the NDI score and .85 (95% CI, .78-.93) for the NRS score for determining between stable and improved patients. Thresholds for the minimum clinically important difference (MCID) for the NDI were 19-percentage points and 1.3 for the NRS. Both the NDI and NRS exhibit fair to moderate test-retest reliability in patients with mechanical neck pain. Both instruments also showed adequate responsiveness in this patient population. However, the MCID required to be certain that the change in scores has surpassed a level that could be contributed to measurement error for the NDI was twice that which has previously been reported. Therefore the ongoing analyses of the properties of the NDI in a patient population with neck pain are warranted.
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                Author and article information

                Journal
                Int J Med Sci
                Int J Med Sci
                ijms
                International Journal of Medical Sciences
                Ivyspring International Publisher (Sydney )
                1449-1907
                2014
                6 February 2014
                : 11
                : 4
                : 309-320
                Affiliations
                1. Pain Management Center of Paducah, Paducah, KY, USA;
                2. Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, USA.
                Author notes
                ✉ Corresponding author: Laxmaiah Manchikanti, M.D. 2831 Lone Oak Road, Paducah, Kentucky 42003, Phone: 270-554-8373 ext. 101, Fax: 270-554-8987 E-mail: drlm@ 123456thepainmd.com .

                Competing Interests: The authors have declared that no competing interest exists.

                Article
                ijmsv11p0309
                10.7150/ijms.8069
                3936024
                24578607
                e74016a2-c1c9-4948-a117-41e729d8c0f8
                © Ivyspring International Publisher. This is an open-access article distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by-nc-nd/3.0/). Reproduction is permitted for personal, noncommercial use, provided that the article is in whole, unmodified, and properly cited.
                History
                : 6 November 2013
                : 1 January 2014
                Categories
                Research Paper

                Medicine
                chronic neck pain,cervical disc herniation,cervical epidural injections,cervical axial pain,cervical discogenic pain,local anesthetics.,epidural steroids

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