OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates (OPT-IN)
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ClinicalTrials.gov Identifier: NCT05848895 |
Recruitment Status :
Recruiting
First Posted : May 8, 2023
Last Update Posted : November 1, 2023
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The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning.
This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants <4 months of age) will be organized into one of two groups:
- Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry.
- Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy).
Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Plagiocephaly, Nonsynostotic Plagiocephaly, Positional Plagiocephaly Cranium; Deformity | Procedure: Osteopathic Manipulative Treatment Behavioral: Standard of Care Repositioning | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates |
Actual Study Start Date : | October 26, 2023 |
Estimated Primary Completion Date : | July 2025 |
Estimated Study Completion Date : | July 2025 |
Arm | Intervention/treatment |
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Experimental: Osteopathic Manipulative Treatment
Patients will be treated once a week with OMT x 8 weeks
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Procedure: Osteopathic Manipulative Treatment
Osteopathic Manipulative Treatment is a manual treatment therapy applied by licensed physicians that consists of using ones hands to improve the structure and function of the body. In this situation it will involve gentle and passive modalities that are well-tolerated by infants. |
Active Comparator: Standard of Care Repositioning
Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning
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Behavioral: Standard of Care Repositioning
Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly. |
- Cranial Vault Asymmetry Index [ Time Frame: 2 years ]Anthropometric measurement of cranial asymmetry
- Head circumference [ Time Frame: 2 years ]Standard growth parameter measured in infants
- Weight [ Time Frame: 2 years ]Standard growth parameter measured in infants
- Medical history [ Time Frame: 12 months ]Patients charts will be reviewed after first year of life to assess for medical issues including otitis media, developmental delay, allergic rhinitis, vision problems, torticollis, hospitalizations, need for a helmet to treat plagiocephaly, colic, reflux/GER, etc.
- Developmental Milestones [ Time Frame: 12 months ]Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.
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Ages Eligible for Study: | 1 Day to 4 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusions:
- Diagnosed with positional plagiocephaly
- Under 4-months of age (between birth - 4 months) at the time of enrollment
Exclusions:
- Preterm birth (<37 weeks)
- Genetic syndromes
- Craniofacial defects/deformities (e.g. cleft lip/palate)
- Brachycephaly/scaphocephaly
- Hypotonia
- Hypertonia
- Craniosynostosis
- Head trauma or other neurological illnesses
- Lost to follow up
- Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions
- Prior helmet therapy, physical therapy, or OMT before the date of enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05848895
Contact: Kimberly J Wolf, DO | 19373699290 | wolfkimb@gmail.com | |
Contact: Jessica Martone, PhD, MSW | 619-693-6303 | jessica.martone@the-promise.org |
United States, California | |
Osteopathic Center San Diego | Recruiting |
San Diego, California, United States, 92123 | |
Contact: Jessica Martone, PhD, MSW 619-693-6303 jessica.martone@the-promise.org | |
Contact: Kimberly Wolf, DO 619-693-6303 kimberly.wolf@the-promise.org | |
Principal Investigator: Kimberly Wolf, DO |
Principal Investigator: | Kimberly J Wolf, DO | Osteopathy's Promise to Children |
Responsible Party: | Kimberly Wolf, Kimberly Wolf, DO, Osteopathy's Promise to Children |
ClinicalTrials.gov Identifier: | NCT05848895 |
Other Study ID Numbers: |
OPC001 |
First Posted: | May 8, 2023 Key Record Dates |
Last Update Posted: | November 1, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Positional Plagiocephaly Nonsynostotic Plagiocephaly Repositioning Osteopathic Manipulative Treatment Cranial asymetry |
Plagiocephaly Plagiocephaly, Nonsynostotic Congenital Abnormalities |
Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases |