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Author (up) Juel, J.; Liguori, S.; Liguori, A.; Valeriani, M.; Graversen, C.; Olesen, S.S.; Drewes, A.M. doi  openurl
  Title A New Method for Sham-Controlled Acupuncture in Experimental Visceral Pain – a Randomized, Single-Blinded Study Type of Study Journal Article
  Year 2015 Publication Pain Pract Abbreviated Journal  
  Volume Issue Pages  
  Keywords Healthy Subjects; Anesthesia and Analgesia; Pain; Visceral Pain; RCT; Pilot Study; Cross-Over Design; Acu Versus Sham; TCM Acupuncture Style; Acupuncture; Fixed Acupuncture Protocol; Restricted Modalities, Acupuncture Only; Sham Control; Non Penetrating Sham, Mechanical; Verum Acupoint Control  
  Abstract OBJECTIVE: Acupuncture is increasingly used as an alternative to medical therapy for various pain conditions. To study the effect of acupuncture in experimental and clinical studies, a control condition with sham acupuncture is needed. However, as such models have not been established in assessment of acupunctures effect against visceral pain, this study aimed to validate a new method for blinded sham acupuncture in experimental rectal pain. METHODS: Fifteen subjects underwent a sequence of either sham or real acupuncture in randomized order. In the sham arm, a hollow inner tube with a sharp tip was fitted into an outer tube and subjects were blinded to the stimulations. Before and after the intervention, pain was induced by rectal stimulation with an inflatable balloon distended until the subjects' pain threshold was reached. The resting electroencephalogram (EEG) was quantified by spectral power analysis to explore the central nervous system effects objectively. Additionally, after the second study day, the subject was asked to indicate the sequence of interventions. RESULTS: A significant increase in rectal balloon volume was observed after sham 12 +/- 21 mL (P = 0.049) and acupuncture 17 +/- 30 mL (P = 0.046). However, the change in volume was not different between groups (P = 0.6). No differences in EEG spectral power distributions between sham and acupuncture were seen (all P > 0.6). The correct sequence of sham and acupuncture was indicated by 36% of the subjects (P = 0.4). CONCLUSIONS: The presented sham procedure provides a valid method for blinding of “sham acupuncture” and may be used in future blinded controlled trials of acupuncture for visceral pain.  
  Address Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Molleparkvej 4, DK-9000 Aalborg, Denmark. amd@rn.dk  
  Publisher (c) 2015 World Institute of Pain.
  Language Number of Treatments 2  
  Treatment Follow-up 5 Weeks Frequency <1/WK Number of Participants 15  
  Time in Treatment 4 Weeks Condition Anesthesia and Analgesia
  Disease Category Healthy Subjects OCSI Score  
  Notes Date of Input: 6/23/2015; Date Modified: 9/29/2015; Availability: --In File--; Priority: Normal; Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Eng; Web: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=26011772 Approved no  
  Call Number OCOM @ refbase @ Serial 1839  
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