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Effect of electroacupuncture at homotopic and heterotopic acupoints on abdominal pain in patients with irritable bowel syndrome: study protocol for a randomized controlled trial.
Trials 2018 October 17
BACKGROUND: Acupuncture has been widely applied in the clinic to treat irritable bowel syndrome (IBS), but the underlying mechanism remains unknown. Diffuse noxious inhibitory control (DNIC) is deficient in patients with IBS, which attenuates the systemic analgesic effect elicited by noxious stimulation that is remote from pain areas. Therefore, the aim of this study is to investigate the analgesic effect of electroacupuncture (EA) at homotopic or heterotopic acupoints on abdominal pain in patients with IBS.
METHODS/DESIGN: This study is a randomized, single-blinded, controlled, four-arm parallel trial. A total of 144 patients will be randomly assigned to four groups: a homotopic noxious stimulation group (group A), a homotopic innocuous stimulation group (group B), a heterotopic noxious stimulation group (group C), and a heterotopic innocuous stimulation group (group D). Each patient will receive 14 sessions of treatment, twice per week for 7 weeks. The primary outcome will be pain intensity measured with the visual analog scale. The secondary outcomes will include the IBS Symptom Severity Scale, IBS Quality of Life questionnaire, pain threshold (PT), and the Symptom Checklist-90 for psychological distress. The PT will be measured before and after every treatment. All other outcomes will be evaluated before the 1st treatment, after 7th and 14th treatment, and 3 months later during follow-up.
DISCUSSION: The aim of this study is to assess the analgesic effect of EA at homotopic (abdomen) acupoints and heterotopic (lower limb) acupoints on abdominal pain in patients with IBS, as well as the difference in analgesic effects between noxious and innocuous stimulation.
TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-15006879 . Registered on 5 August 2015.
METHODS/DESIGN: This study is a randomized, single-blinded, controlled, four-arm parallel trial. A total of 144 patients will be randomly assigned to four groups: a homotopic noxious stimulation group (group A), a homotopic innocuous stimulation group (group B), a heterotopic noxious stimulation group (group C), and a heterotopic innocuous stimulation group (group D). Each patient will receive 14 sessions of treatment, twice per week for 7 weeks. The primary outcome will be pain intensity measured with the visual analog scale. The secondary outcomes will include the IBS Symptom Severity Scale, IBS Quality of Life questionnaire, pain threshold (PT), and the Symptom Checklist-90 for psychological distress. The PT will be measured before and after every treatment. All other outcomes will be evaluated before the 1st treatment, after 7th and 14th treatment, and 3 months later during follow-up.
DISCUSSION: The aim of this study is to assess the analgesic effect of EA at homotopic (abdomen) acupoints and heterotopic (lower limb) acupoints on abdominal pain in patients with IBS, as well as the difference in analgesic effects between noxious and innocuous stimulation.
TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-15006879 . Registered on 5 August 2015.
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