Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Scuola Superiore di Osteopatia Italiana | OTHER |
Not provided
Not provided
Not provided
Not provided
The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.
Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life.
Four months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.
Early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.
In paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathic manipulative therapy | Experimental | Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). Osteopathic Manipulative Therapy. Participant OMT group receive 6 OMTh in 3 months, as follows: first at baseline, the second after 1 week, the third after 3 weeks, and then once every 3 weeks for three more visits. |
|
| Light Touch Therapy | Sham Comparator | Repositioning Therapy plus Light Touch Therapy (LTT) Participants to the LTT group receive the LTT protocol at the same date of the OMTh group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic manipulative therapy (OMTh) | Other | The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome. | Baseline and 3 months |
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome. | Follow-up at 1 year of age |
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome. | At 3 months |
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of Nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104<108 MILD Nonsynostotic Plagiocephaly ODDI score >=108<112 MODERATE Nonsynostotic Plagiocephaly ODDI score >= 112 SEVERE Nonsynostotic Plagiocephaly Higher score means a worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Cranial Proportion Index (CPI) | Change of the width and length diameter measured with Plagiocephalometry. | The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age. |
| Adverse Event |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudio G Priolo, Medical | Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy | Study Director |
| Daniele Farina, Medical | Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza. | Torino | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21187783 | Background | Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part I: terminology, diagnosis, and etiopathogenesis. J Craniofac Surg. 2011 Jan;22(1):9-16. doi: 10.1097/SCS.0b013e3181f6c313. | |
| 21187782 | Background | Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part II: prevention and treatment. J Craniofac Surg. 2011 Jan;22(1):17-23. doi: 10.1097/SCS.0b013e3181f6c342. |
Not provided
Not provided
Not provided
Of the 129 infants screened at Sant'Anna Hospital, 96 were enrolled between September 2016 and June 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Osteopathic Manipulative Therapy Plus Repositioning Therapy | Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopath with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep". |
| FG001 | Light Touch Therapy Plus Repositioning Therapy | Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopath with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep". |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Osteopathic Manipulative Therapy Plus Repositioning Therapy | Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI )score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep". |
| 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 | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome. | Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method. | Posted | Count of Participants | Participants | Baseline and 3 months |
|
From first treatment (1 week post-baseline) up to end of treatment course (3 months).
Symptoms such as irritability occured after the Osteopathic Manipulative Therapy or Light Touch Therapy
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Osteopathic Manipulative Therapy Plus Repositioning Therapy | Participants received Osteopathic Manipulative Therapy (OMTh) plus Repositioning Therapy. OMTh: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Claudio G Priolo | Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy | 0039 3471403064 | claudiog.priolo@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2019 | Aug 1, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D049068 | Plagiocephaly, Nonsynostotic |
| ID | Term |
|---|---|
| D059041 | Plagiocephaly |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
Not provided
Not provided
A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy
Not provided
Not provided
Infants were randomly assigned to two groups, OMT and LTT by using a random number generator, prepared in advance by an independent biostatistician. Sequentially numbered, opaque, and sealed envelopes were used.
Clinician-Investigators, neonatology staff, the physical therapist, and the osteopath in charge of assessment were unaware of the random list.
Infants' parents, after having signed the informed consent form, chose the numbered envelope and were unaware of the random list for the whole period of study.
The two osteopaths in charge of Osteopathic manipulative therapy and Light Touch Therapy were unblinded to group assignment.
Clinical outcomes were assessed by a biostatistician who was not involved in the patients' clinical allocation and management.
|
| Light Touch Therapy (LTT) | Other | The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force. |
|
| Repositioning therapy | Other | It consists of strategies that guide the parents to position the baby "back to sleep", by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed. |
|
| Follow-up at one year of age |
Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy
| From first treatment (1 week post-baseline) up to end of treatment course (3 months). |
| 21726785 | Background | Lennartsson F. Developing guidelines for child health care nurses to prevent nonsynostotic plagiocephaly: searching for the evidence. J Pediatr Nurs. 2011 Aug;26(4):348-58. doi: 10.1016/j.pedn.2010.07.003. Epub 2010 Sep 25. |
| 21982132 | Background | Lessard S, Gagnon I, Trottier N. Exploring the impact of osteopathic treatment on cranial asymmetries associated with nonsynostotic plagiocephaly in infants. Complement Ther Clin Pract. 2011 Nov;17(4):193-8. doi: 10.1016/j.ctcp.2011.02.001. Epub 2011 Mar 5. |
| 16211401 | Background | van Vlimmeren LA, Takken T, van Adrichem LN, van der Graaf Y, Helders PJ, Engelbert RH. Plagiocephalometry: a non-invasive method to quantify asymmetry of the skull; a reliability study. Eur J Pediatr. 2006 Mar;165(3):149-57. doi: 10.1007/s00431-005-0011-1. Epub 2005 Oct 7. |
| 36451623 | Derived | Bagagiolo D, Priolo CG, Favre EM, Pangallo A, Didio A, Sbarbaro M, Borro T, Dacco S, Manzoni P, Farina D. A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with Nonsynostotic Plagiocephaly. Am J Perinatol. 2022 Dec;39(S 01):S52-S62. doi: 10.1055/s-0042-1758723. Epub 2022 Nov 30. |
| BG001 | Light Touch Therapy Plus Repositioning Therapy | Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI) score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep". |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational Age | Mean | Standard Deviation | weeks |
|
| Presentation at birth | Count of Participants | Participants |
|
| Birth weight | Mean | Standard Deviation | grams |
|
| Mother's first pregnancy | Count of Participants | Participants |
|
| Multiple birth | Count of Participants | Participants |
|
| Delivery | Count of Participants | Participants |
|
| Feeding | Count of Participants | Participants |
|
| Sleeping | Count of Participants | Participants |
|
| Daytime | Count of Participants | Participants |
|
| Mother's age | Mean | Standard Deviation | years |
|
| Father's age | Mean | Standard Deviation | years |
|
| Age end of study | Mean | Standard Deviation | months |
|
| OG001 | Light Touch Therapy Plus Repositioning Therapy | Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks. |
|
|
|
| Primary | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome. | Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method. | Posted | Count of Participants | Participants | Follow-up at 1 year of age |
|
|
|
|
| Primary | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome. | Per Protocol population, defined as participants completing the three months intervention. | Posted | Count of Participants | Participants | At 3 months |
|
|
|
|
| Primary | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of Nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104<108 MILD Nonsynostotic Plagiocephaly ODDI score >=108<112 MODERATE Nonsynostotic Plagiocephaly ODDI score >= 112 SEVERE Nonsynostotic Plagiocephaly Higher score means a worse outcome. | Per Protocol population, defined as participants completing the one year of age follow-up visit. | Posted | Count of Participants | Participants | Follow-up at one year of age |
|
|
|
|
| Secondary | Cranial Proportion Index (CPI) | Change of the width and length diameter measured with Plagiocephalometry. | Data were not collected for lack of clinical relevance | Posted | The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age. |
|
|
| Secondary | Adverse Event | Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy | Any Adverse Events | Posted | Count of Participants | Participants | From first treatment (1 week post-baseline) up to end of treatment course (3 months). |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Light Touch Therapy Plus Repositioning Therapy | Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks. | 0 | 48 | 0 | 48 | 0 | 48 |
Not provided
Not provided
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012046 | Rehabilitation |