A Phase 2 interventional study of Acupuncture with Seirin 020x15 mm sterile acupuncture needle in Infant Colic, sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 3 Weeks to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by University of Oslo · Phase 2, Interventional, and Treatment
Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture.
The investigators plan to study whether the perceived opinion on positive results can be verified in a multi-center clinical trial. The investigators aim to measure the effect of standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized singe blinded prospective multi-center study, starting September 2009. The study will be done in thirteen locations in Norway by specialists in General Practice trained in acupuncture.
The investigators intend to include a total of 130 patients, 65 in the intervention group and 65 in the control group.
148 studies on the registry are indexed under Colic; 21 are open to participants now.
This study's enrollment of 90 is close to the median of 88 across 122 interventional studies indexed under Colic.
Browse Colic studies →University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acupuncture with Seirin 020x15 mm sterile acupuncture needle: Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36 on infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition: Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.
Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle
Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition: Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks. The Control group will have no intervention.
Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.
Also known as: Seirin 020x15mm sterile acupuncture needle
Change in Crying Time Per 24 Hour Period.
Crying time per 24 hour period at baseline and post treatment
Time frame: 6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.
Parents Evaluation of Benefit to the Child.
Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified.
Time frame: 5 days, 1 , and 4 weeks after the first treatment
The inclusion period was from September 2009 to December 2012.13 GP offices participated. The participating doctors were all GP specialists with a minimum of 300 hours of acupuncture education and fi ve years of practising acupuncture. The patients fulfi lled Wessel ' s criteria and were born at full term.
| Milestone | Acupuncture | Control |
|---|---|---|
| Started | 45 | 45 |
| Completed | 38 | 41 |
| Not completed | 7 | 4 |
| Withdrew: Lost to follow-up | 6 | 3 |
| Withdrew: Intercurrent febrile illness | 1 | 1 |
Crying time per 24 hour period at baseline and post treatment
| minutes crying time pr 24 hour | Acupuncture | Control |
|---|---|---|
| Day 1 and 2-baseline | 220 (195 to 245) | 212 (183 to 241) |
| Day 3- 1 intervention day | 230 (180 to 281) | 186 (142 to 230) |
| Day 4- 2 intervention day | 180 (128 to 232) | 185 (131 to 239) |
| Day 5- 3 intervention day | 129 (97 to 162) | 167 (123 to 211) |
| Day 6- 1 day after intervention | 120 (94 to 145) | 142 (106 to 179) |
| Day12- 1 week after intervention | 121 (79 to 164) | 120 (91 to 149) |
| Day 33- 4 weeks after intervention | 89 (55 to 123) | 97 (67 to 126) |
Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified.
| units on a scale | Acupuncture | Control |
|---|---|---|
| Improvement day 5 | 2.87 ± 0.844 | 2.78 ± 0.917 |
| Improvement day 12 | 3.62 ± 0.861 | 3.27 ± 0.902 |
| Improvement day 33 | 4.03 ± 0.885 | 3.51 ± 1.146 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acupuncture | — | 0/45 (0%) | 2/45 (4.4%) |
| Control | — | 0/45 (0%) | 8/45 (17.8%) |
| Event | Acupuncture | Control |
|---|---|---|
| HickupGastrointestinal disorders | 1/45 | 0/45 |
| Increased regurgitationGastrointestinal disorders | 1/45 | 0/45 |
| Small HematomaGeneral disorders | 0/45 | 1/45 |
| CryingGeneral disorders | 0/45 | 1/45 |
| RestlessnessGeneral disorders | 0/45 | 1/45 |
| Excessive stoolsGastrointestinal disorders | 0/45 | 1/45 |
| Frequent defecationGastrointestinal disorders | 0/45 | 1/45 |
| Light sedationGeneral disorders | 0/45 | 1/45 |
| Abdominal painGastrointestinal disorders | 0/45 | 1/45 |
| UneaseGeneral disorders | 0/45 | 1/45 |
We analyzed 79 crying diaries and 84 interviews. The baseline characteristics, except crying time is based on the 84 interviews where we had complete data. The crying time is based on the 79 crying diaries
| Age, Continuous(weeks) | Acupuncture | Control | Total |
|---|---|---|---|
| Mean | 6 (3 to 13) | 6 (3 to 9) | 6 (3 to 13) |
| Sex: Female, Male(Participants) | Acupuncture | Control | Total |
|---|---|---|---|
| Female | 22 | 20 | 42 |
| Male | 22 | 20 | 42 |
| baseline crying time in minutes(crying time in minutes) | Acupuncture | Control | Total |
|---|---|---|---|
| Mean | 220 (80 to 394) | 212 (0 to 353) | 216 (0 to 394) |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Oslo