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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture with Seirin 020x15 mm sterile acupuncture needle | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Crying Time Per 24 Hour Period. | Crying time per 24 hour period at baseline and post treatment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days, 1 , and 4 weeks after the first treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holgeir Skjeie, MD | Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo. | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24228748 | Result | Skjeie H, Skonnord T, Fetveit A, Brekke M. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013 Dec;31(4):190-6. doi: 10.3109/02813432.2013.862915. Epub 2013 Nov 15. | |
| 21450707 | Derived | Skjeie H, Skonnord T, Fetveit A, Brekke M. A pilot study of ST36 acupuncture for infantile colic. Acupunct Med. 2011 Jun;29(2):103-7. doi: 10.1136/aim.2010.003590. Epub 2011 Mar 29. |
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113 pasients were recruited. 23 were excluded beacuse of spontanous improving of symptoms, transportation problems, change of mind regarding participation.90 patients were randomized. 79 crying diaries and 84 interviews were analysed.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | 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. 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. |
| FG001 | Control | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | 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. 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. The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Crying Time Per 24 Hour Period. | Crying time per 24 hour period at baseline and post treatment | Posted | Mean | 95% Confidence Interval | minutes crying time pr 24 hour | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hickup | Gastrointestinal disorders | Non-systematic Assessment |
Our choice of acupuncture points and technique could be inferior to other more potent acupuncture approaches.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holgeir Skjeie | Department of General practice, University of Oslo | +4722850550 | Holgeir.Skjeie@medisin.uio.no |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| BG001 | Control | 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. The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time. |
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| baseline crying time in minutes | Daily accumulative crying time pr 24 hours as measured in a crying registration diary by the parents and returned to the investigators after the registration period. | Mean | Full Range | crying time in minutes |
|
| OG001 | Control | 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. |
|
|
| Secondary | 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. | The differences in numbers on parents evaluation of the childs condition (37 and 38) is due to one location assistant not reporting back on these results. Thus the number of interviews, 84, and secondary outcome data is not consistent with the numbers in the flow diagram. | Posted | Mean | Standard Deviation | units on a scale | 5 days, 1 , and 4 weeks after the first treatment |
|
|
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| 0 |
| 45 |
| 2 |
| 45 |
| EG001 | Control | 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. | 0 | 45 | 8 | 45 |
| Increased regurgitation | Gastrointestinal disorders |
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| Small Hematoma | General disorders |
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| Crying | General disorders |
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| Restlessness | General disorders |
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| Excessive stools | Gastrointestinal disorders |
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| Frequent defecation | Gastrointestinal disorders |
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| Light sedation | General disorders |
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| Abdominal pain | Gastrointestinal disorders |
|
| Unease | General disorders |
|
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| Improvement day 33 |
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