Nonsynostotic Plagiocephaly
Conditions
Keywords
Positional Plagiocephaly, Deformational Plagiocephaly,
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
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.
Sponsors
Scuola Superiore di Osteopatia Italiana
PRIOLO CLAUDIO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Months
Healthy volunteers
No
Inclusion criteria
* Infants with NSP, ODDI score of 104% or more. * To be at term corrected age if born prematurely.
Exclusion criteria
* Synostotic Plagiocephaly * Infant who underwent an osteopathic manipulative treatment before the enrolment * Dysmorphisms * Syndromes * Congenital Muscular Torcicolis * Cerebral Palsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | Baseline and 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. |
| Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | Follow-up 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cranial Proportion Index (CPI) | The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age. | Change of the width and length diameter measured with Plagiocephalometry. |
| Adverse Event | From first treatment (1 week post-baseline) up to end of treatment course (3 months). | Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy |
Countries
Italy
Participant flow
Recruitment details
Of the 129 infants screened at Sant'Anna Hospital, 96 were enrolled between September 2016 and June 2019.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| 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. | 48 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 8 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Osteopathic Manipulative Therapy Plus Repositioning Therapy | Light Touch Therapy Plus Repositioning Therapy | Total |
|---|---|---|---|
| Age, Continuous | 3.1 months STANDARD_DEVIATION 1.4 | 3.2 months STANDARD_DEVIATION 1.6 | 3.1 months STANDARD_DEVIATION 1.5 |
| Age end of study | 6.1 months STANDARD_DEVIATION 1.4 | 6.2 months STANDARD_DEVIATION 1.6 | 6.15 months STANDARD_DEVIATION 1.15 |
| Birth weight | 2657 grams STANDARD_DEVIATION 945 | 2290 grams STANDARD_DEVIATION 995 | 2473 grams STANDARD_DEVIATION 970 |
| Daytime Supine | 35 Participants | 34 Participants | 69 Participants |
| Daytime Variable | 13 Participants | 14 Participants | 27 Participants |
| Delivery Assisted | 9 Participants | 6 Participants | 15 Participants |
| Delivery Cesarean | 21 Participants | 27 Participants | 48 Participants |
| Delivery Vacuum - Forceps | 4 Participants | 4 Participants | 8 Participants |
| Delivery Vaginal | 14 Participants | 11 Participants | 25 Participants |
| Father's age | 36.9 years STANDARD_DEVIATION 6.8 | 37.1 years STANDARD_DEVIATION 6.8 | 37 years STANDARD_DEVIATION 6.8 |
| Feeding Bottle | 22 Participants | 26 Participants | 48 Participants |
| Feeding Maternal | 14 Participants | 12 Participants | 26 Participants |
| Feeding Mix | 12 Participants | 10 Participants | 22 Participants |
| Gestational Age | 36.7 weeks STANDARD_DEVIATION 3.9 | 34.3 weeks STANDARD_DEVIATION 4.6 | 35.5 weeks STANDARD_DEVIATION 4.2 |
| Mother's age | 33.8 years STANDARD_DEVIATION 5.4 | 35.1 years STANDARD_DEVIATION 6.5 | 34.45 years STANDARD_DEVIATION 5.95 |
| Mother's first pregnancy | 24 Participants | 26 Participants | 50 Participants |
| Multiple birth | 6 Participants | 10 Participants | 16 Participants |
| Presentation at birth Breech | 2 Participants | 6 Participants | 8 Participants |
| Presentation at birth Cefalic | 39 Participants | 37 Participants | 76 Participants |
| Presentation at birth Trasvers | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 48 Participants | 96 Participants |
| Region of Enrollment Italy | 48 participants | 48 participants | 96 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 27 Participants | 26 Participants | 53 Participants |
| Sleeping Supine | 46 Participants | 48 Participants | 94 Participants |
| Sleeping Variable | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
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.
Time frame: Follow-up at 1 year of age
Population: Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score <104% | 28 Participants |
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score >=104% | 20 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score <104% | 5 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score >=104% | 43 Participants |
p-value: 0.0195% CI: [2.36, 13.27]Relative Risk (RR)
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.
Time frame: Follow-up at one year of age
Population: Per Protocol population, defined as participants completing the one year of age follow-up visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score <104% | 28 Participants |
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score >=104% | 13 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score <104% | 5 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. | ODDI score >=104% | 31 Participants |
p-value: 0.0195% CI: [2.12, 11.38]Risk Ratio (RR)
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.
Time frame: Baseline and 3 months
Population: Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score <104% | 23 Participants |
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score >=104% | 25 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score <104% | 3 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score >=104% | 45 Participants |
p-value: 0.0195% CI: [2.46, 23.84]Risk Ratio (RR)
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.
Time frame: At 3 months
Population: Per Protocol population, defined as participants completing the three months intervention.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score <104% | 23 Participants |
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score >=104% | 22 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score <104% | 3 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months | ODDI score >=104% | 41 Participants |
p-value: 0.0195% CI: [2.42, 23.18]Risk Ratio (RR)
Secondary
Adverse Event
Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy
Time frame: From first treatment (1 week post-baseline) up to end of treatment course (3 months).
Population: Any Adverse Events
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Adverse Event | Other adverse events such as irritability | 0 Participants |
| Osteopathic Manipulative Therapy Plus Repositioning Therapy | Adverse Event | Serious Adverse events | 0 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Adverse Event | Serious Adverse events | 0 Participants |
| Light Touch Therapy Plus Repositioning Therapy | Adverse Event | Other adverse events such as irritability | 0 Participants |
Secondary
Cranial Proportion Index (CPI)
Change of the width and length diameter measured with Plagiocephalometry.
Time frame: The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.
Population: Data were not collected for lack of clinical relevance