Trial Outcomes & Findings for Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly (NCT NCT03970395)
NCT ID: NCT03970395
Last Updated: 2021-02-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2021-02-12
Participant Flow
Of the 129 infants screened at Sant'Anna Hospital, 96 were enrolled between September 2016 and June 2019.
Participant milestones
| Measure |
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".
|
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".
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
7
|
12
|
Reasons for withdrawal
| Measure |
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".
|
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".
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
Baseline Characteristics
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Baseline characteristics by cohort
| Measure |
Osteopathic Manipulative Therapy Plus Repositioning Therapy
n=48 Participants
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".
|
Light Touch Therapy Plus Repositioning Therapy
n=48 Participants
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".
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.1 months
STANDARD_DEVIATION 1.4 • n=5 Participants
|
3.2 months
STANDARD_DEVIATION 1.6 • n=7 Participants
|
3.1 months
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
48 participants
n=5 Participants
|
48 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Gestational Age
|
36.7 weeks
STANDARD_DEVIATION 3.9 • n=5 Participants
|
34.3 weeks
STANDARD_DEVIATION 4.6 • n=7 Participants
|
35.5 weeks
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Presentation at birth
Cefalic
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Presentation at birth
Breech
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Presentation at birth
Trasvers
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Birth weight
|
2657 grams
STANDARD_DEVIATION 945 • n=5 Participants
|
2290 grams
STANDARD_DEVIATION 995 • n=7 Participants
|
2473 grams
STANDARD_DEVIATION 970 • n=5 Participants
|
|
Mother's first pregnancy
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Multiple birth
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Delivery
Vaginal
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Delivery
Assisted
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Delivery
Vacuum - Forceps
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Delivery
Cesarean
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Feeding
Maternal
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Feeding
Bottle
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Feeding
Mix
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sleeping
Supine
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sleeping
Variable
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Daytime
Supine
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Daytime
Variable
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Mother's age
|
33.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
34.45 years
STANDARD_DEVIATION 5.95 • n=5 Participants
|
|
Father's age
|
36.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
37 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Age end of study
|
6.1 months
STANDARD_DEVIATION 1.4 • n=5 Participants
|
6.2 months
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.15 months
STANDARD_DEVIATION 1.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
Osteopathic Manipulative Therapy Plus Repositioning Therapy
n=48 Participants
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.
|
Light Touch Therapy Plus Repositioning Therapy
n=48 Participants
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.
|
|---|---|---|
|
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
|
3 Participants
|
|
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
|
45 Participants
|
PRIMARY outcome
Timeframe: Follow-up at 1 year of agePopulation: Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.
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.
Outcome measures
| Measure |
Osteopathic Manipulative Therapy Plus Repositioning Therapy
n=48 Participants
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.
|
Light Touch Therapy Plus Repositioning Therapy
n=48 Participants
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.
|
|---|---|---|
|
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
|
5 Participants
|
|
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
|
43 Participants
|
PRIMARY outcome
Timeframe: At 3 monthsPopulation: Per Protocol population, defined as participants completing the three months intervention.
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.
Outcome measures
| Measure |
Osteopathic Manipulative Therapy Plus Repositioning Therapy
n=45 Participants
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.
|
Light Touch Therapy Plus Repositioning Therapy
n=44 Participants
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.
|
|---|---|---|
|
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
|
3 Participants
|
|
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
|
41 Participants
|
PRIMARY outcome
Timeframe: Follow-up at one year of agePopulation: Per Protocol population, defined as participants completing the one year of age follow-up visit.
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.
Outcome measures
| Measure |
Osteopathic Manipulative Therapy Plus Repositioning Therapy
n=41 Participants
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.
|
Light Touch Therapy Plus Repositioning Therapy
n=36 Participants
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.
|
|---|---|---|
|
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
|
5 Participants
|
|
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
|
31 Participants
|
SECONDARY outcome
Timeframe: 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
Change of the width and length diameter measured with Plagiocephalometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first treatment (1 week post-baseline) up to end of treatment course (3 months).Population: Any Adverse Events
Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy
Outcome measures
| Measure |
Osteopathic Manipulative Therapy Plus Repositioning Therapy
n=48 Participants
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.
|
Light Touch Therapy Plus Repositioning Therapy
n=48 Participants
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.
|
|---|---|---|
|
Adverse Event
Serious Adverse events
|
0 Participants
|
0 Participants
|
|
Adverse Event
Other adverse events such as irritability
|
0 Participants
|
0 Participants
|
Adverse Events
Osteopathic Manipulative Therapy Plus Repositioning Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Light Touch Therapy Plus Repositioning Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Claudio G Priolo
Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy
Phone: 0039 3471403064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place