+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial

Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial

Lancet. Gastroenterology and Hepatology 2(10): 727-737

Development of safe and effective therapies for paediatric abdominal pain-related functional gastrointestinal disorders is needed. A non-invasive, US Food and Drug Administration-cleared device (Neuro-Stim, Innovative Health Solutions, IN, USA) delivers percutaneous electrical nerve field stimulation (PENFS) in the external ear to modulate central pain pathways. In this study, we evaluated the efficacy of PENFS in adolescents with abdominal pain-related functional gastrointestinal disorders. In this randomised, sham-controlled trial, we enrolled adolescents (aged 11-18 years) who met Rome III criteria for abdominal pain-related functional gastrointestinal disorders from a single US outpatient gastroenterology clinic. Patients were randomly assigned (1:1) with a computer-generated randomisation scheme to active treatment or sham (no electrical charge) for 4 weeks. Patients were stratified by sex and presence or absence of nausea. Allocation was concealed from participants, caregivers, and the research team. The primary efficacy endpoint was change in abdominal pain scores. We measured improvement in worst abdominal pain and composite pain score using the Pain Frequency-Severity-Duration (PFSD) scale. Participants with less than 1 week of data and those with organic disease identified after enrolment were excluded from the modified intention-to-treat population. This trial has been completed and is registered with ClinicalTrials.gov, number NCT02367729. Between June 18, 2015, and Nov 17, 2016, 115 children with abdominal pain-related functional gastrointestinal disorders were enrolled and assigned to either PENFS (n=60) with an active device or sham (n=55). After exclusion of patients who discontinued treatment (n=1 in the PENFS group; n=7 in the sham group) and those who were excluded after randomisation because they had organic disease (n=2 in the PENFS group; n=1 in the sham group), 57 patients in the PENFS group and 47 patients in the sham group were included in the primary analysis. Patients in the PENFS group had greater reduction in worst pain compared with sham after 3 weeks of treatment (PENFS: median score 5·0 [IQR 4·0-7·0]; sham: 7·0 [5·0-9·0]; least square means estimate of change in worse pain 2·15 [95% CI 1·37-2·93], p<0·0001). Effects were sustained for an extended period (median follow-up 9·2 weeks [IQR 6·4-13·4]) in the PENFS group: median 8·0 (IQR 7·0-9·0) at baseline to 6·0 (5·0-8·0) at follow-up versus sham: 7·5 (6·0-9·0) at baseline to 7·0 (5·0-8·0) at follow-up (p<0·0001). Median PFSD composite scores also decreased significantly in the PENFS group (from 24·5 [IQR 16·8-33.3] to 8·4 [3·2-16·2]) compared with sham (from 22·8 [IQR 8·4-38·2] to 15·2 [4·4-36·8]) with a mean decrease of 11·48 (95% CI 6·63-16·32; p<0·0001) after 3 weeks. These effects were sustained at extended follow-up in the PENFS group: median 24·5 (IQR 16·8-33·3) at baseline to 12 (3·6-22·5) at follow-up, compared with sham: 22·8 (8·4-38·2) at baseline to 16·8 (4·8-33·6) at follow-up (p=0·018). Ten patients reported side-effects (three of whom discontinued the study): ear discomfort (n=6; three in the PENFS group, three in the sham group), adhesive allergy (n=3; one in the PENFS group, two in the sham group), and syncope due to needle phobia (n=1; in the sham group). There were no serious adverse events. Our results show that PENFS with Neuro-Stim has sustained efficacy for abdominal pain-related functional gastrointestinal disorders in adolescents. This safe and effective approach expands treatment options and should be considered as a non-pharmacological alternative for these disorders. American Neurogastroenterology and Motility Society.

Please choose payment method:

(PDF emailed within 0-6 h: $19.90)

Accession: 060013226

Download citation: RISBibTeXText

PMID: 28826627

DOI: 10.1016/s2468-1253(17)30253-4

Related references

Op-7 Therapeutic Effects Of Domperidone On Abdominal Pain-Predominant Functional Gastrointestinal Disorders: Randomized, Double-Blind, Placebo- Controlled Trial. Journal of Pediatric Gastroenterology and Nutrition 61(4): 511-512, 2015

Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial. Bmc Musculoskeletal Disorders 16: 248, 2016

Reflexology for the treatment of pain in people with multiple sclerosis: a double-blind randomised sham-controlled clinical trial. Multiple Sclerosis 15(11): 1329-1338, 2010

Yoga Therapy for Abdominal Pain-Related Functional Gastrointestinal Disorders in Children: A Randomized Controlled Trial. Journal of Pediatric Gastroenterology and Nutrition 63(5): 481-487, 2016

Su2054 Yoga Therapy for Children With Abdominal Pain Related-Functional Gastrointestinal Disorders. a Randomized Controlled Trial. Gastroenterology 148(4): S-586, 2015

Randomised sham-controlled double-blind multicentre clinical trial to ascertain the effect of percutaneous radiofrequency treatment for lumbar facet joint pain. Bone and Joint Journal 98-B(11): 1526-1533, 2016

Assessment of the effectiveness and safety of ethosuximide in the treatment of abdominal pain related to irritable bowel syndrome - IBSET: protocol of a randomised, parallel, controlled, double-blind and multicentre trial. BMJ Open 7(7): E015380, 2018

The effect of triple vs. double nonopioid therapy on postoperative pain and functional outcome after abdominal hysterectomy: a randomised double-blind control trial. European Journal of Anaesthesiology 32(4): 269-276, 2016

No use for laparoscopic adhesiolysis in patients with chronic abdominal pain: a double-blind randomised controlled multi-centre trial. Nederlands Tijdschrift Voor Geneeskunde 148(24): 1218; Author Reply 1218-9, 2004

Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial-a study protocol. BMJ Open 9(2): E023296, 2019

A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children. Alimentary Pharmacology and Therapeutics 25(2): 177-184, 2007

Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Oncology 18(10): 1411-1422, 2017

Traditional acupuncture for reflex sympathetic dystrophy: a randomised, sham-controlled, double-blind trial. Acupuncture in Medicine 13(2): 78-80, 1995

Antidepressants for the treatment of abdominal pain-related functional gastrointestinal disorders in children and adolescents. Cochrane Database of Systematic Reviews 2011(7): Cd008013, 2011

Cochrane Antidepressants for the treatment of abdominal pain-related functional gastrointestinal disorders in children and adolescents. 2012