Osteopathic Treatment vs Repositioning for Flat Head Syndrome

(OPT-IN Trial)

Overseen By Jessica Martone, PhD, MSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Osteopathy's Promise to Children

Disqualifiers: Preterm birth, Genetic syndromes, Craniofacial defects, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for flat head syndrome in infants: osteopathic manipulative treatment (OMT), which uses hands-on techniques to improve head shape, and repositioning, where parents adjust how their baby lies to help reshape the head. The researchers aim to determine if OMT leads to better head symmetry compared to repositioning. Infants under 4 months old diagnosed with positional plagiocephaly (flat head syndrome) may be suitable for this trial. Participants will try both treatments, starting with one method for 8 weeks, then switching to the other. As an unphased trial, this study provides a unique opportunity for parents to explore innovative treatment options for their infants' flat head syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. Since the trial involves infants under 4 months of age, it's best to consult with the trial coordinators or your child's doctor for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that osteopathic manipulative treatment (OMT) is generally safe for children. Studies have found that OMT is used for various conditions in kids and is usually well-tolerated. However, more research is needed to confirm its safety with solid statistics. While OMT is considered safe, not all possible side effects are fully known.

The trial also includes standard care repositioning, which is already the usual care for flat head syndrome. No new safety information is needed for this part of the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about examining osteopathic manipulative treatment (OMT) for flat head syndrome because it offers a hands-on, holistic approach that differs from traditional methods like repositioning. OMT involves gentle manipulation of the baby's body, potentially improving cranial symmetry through physical adjustments, which is a unique mechanism compared to simply repositioning the infant's head. This approach may provide a more active intervention to help correct head shape, offering a new avenue for treatment that goes beyond the passive strategies typically used today.

What evidence suggests that this trial's treatments could be effective for flat head syndrome?

Research has shown that osteopathic manipulative treatment (OMT), which participants in this trial may receive, can help improve head shape in infants with flat head syndrome. One study found that children who received OMT had better head shape outcomes than those who only used repositioning therapy. In this trial, some participants will receive OMT, which involves hands-on techniques to adjust the skull's structure and function. Others will receive standard repositioning care, which remains commonly used. These findings suggest that OMT might be a more effective treatment option. Early studies highlight the potential benefits of adding OMT to the treatment plan for infants with this condition. ^{1 2 6 7 8}

Who Is on the Research Team?

Kimberly J Wolf, DO

Principal Investigator

Osteopathy's Promise to Children

Are You a Good Fit for This Trial?

This trial is for infants under 4 months old diagnosed with positional plagiocephaly, also known as flat head syndrome. It's not for those born preterm, with genetic syndromes, muscle tone disorders, craniofacial defects like cleft lip/palate, prior treatments such as helmet therapy or OMT, or other neurological issues.

Inclusion Criteria

My child is younger than 4 months old.

My child has been diagnosed with a flat spot on the head from sleeping in one position.

Exclusion Criteria

Preterm birth (<37 weeks)

I have low muscle tone.

Craniofacial defects/deformities (e.g. cleft lip/palate)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either OMT or standard care repositioning for 8 weeks

8 weeks

8 visits (in-person)

Treatment Phase 2

Participants cross-over to the other treatment group (OMT or repositioning) for another 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment
• Standard of Care Repositioning

Trial Overview The study compares osteopathic manipulative treatment (OMT), focusing on cranial symmetry restoration to standard care which involves repositioning by parents. Infants will first receive one treatment for 8 weeks and then switch to the other method in this crossover randomized trial.

How Is the Trial Designed?

Group I: Osteopathic Manipulative Treatment Experimental Treatment 1 Intervention

Patients will be treated once a week with OMT x 8 weeks

Group II: Standard of Care Repositioning Active Control 1 Intervention

Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning

Osteopathic Manipulative Treatment is already approved in United States, European Union for the following indications:

Approved in United States as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Approved in European Union as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Who Is Running the Clinical Trial?

Osteopathy's Promise to Children

Lead Sponsor

Trials

1

Recruited

120+

Hollis King, DO

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

A survey of 313 MD students revealed that only 31.1% were familiar with osteopathic manipulative treatment (OMT), but 82.1% expressed interest in a 2-week elective course on OMT, indicating a significant demand for education in this area.

Students who had prior exposure to OMT, such as observing it in clinical settings or having family treated by DO physicians, showed higher interest in learning about OMT, suggesting that familiarity may enhance interest in integrating OMT into their future practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and interest in osteopathic manipulative treatment in allopathic medical students. Darby, A., Parascando, JA., Lipinski, M., et al.[2023]

In a study of 1,238 geriatric patients receiving osteopathic manipulative treatment (OMT) over three years, the majority presented with neuromusculoskeletal concerns, particularly back issues, and showed significant improvement in their conditions after treatment.

The most commonly used OMT techniques were consistent with national practices, with muscle energy techniques being the most frequently documented, while the use of high-velocity, low-amplitude techniques decreased with age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and treatment of geriatric patients in an osteopathic neuromusculoskeletal medicine clinic. King, AA., Cox, J., Bhatia, S., et al.[2021]

A study of 537 pediatric patients receiving osteopathic manipulative treatment (OMT) revealed that musculoskeletal issues were the most common complaints in children aged 6 and older, while younger children often presented with feeding difficulties and colic.

The most frequently used OMT technique was myofascial release, and the study highlighted significant differences in somatic dysfunction assessments based on payment methods, suggesting that insurance status may influence the extent of treatment provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Treatment of Pediatric Patients in an Osteopathic Manipulative Medicine Clinic. Kaiser, G., Degenhardt, BF., Michael Menke, J., et al.[2022]

A survey of 491 first- and second-year osteopathic medical students revealed that a strong majority (76%-95%) agree with osteopathic philosophy, particularly those with prior exposure to osteopathic manipulative treatment (OMT).

Students' intentions to use OMT in their future practice were influenced by their reasons for choosing osteopathic medicine, with those motivated by a general desire to be a physician showing less agreement with osteopathic principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic medical students' beliefs about osteopathic manipulative treatment at 4 colleges of osteopathic medicine. Draper, BB., Johnson, JC., Fossum, C., et al.[2022]

The study protocol for using osteopathic manipulative medicine (OMM) alongside standard care for middle ear effusion (MEE) after acute otitis media (AOM) was successfully implemented without any serious adverse events, indicating that OMM is a safe treatment option.

Out of 56 screened patients, 34 were enrolled and 26 completed the study, highlighting challenges in subject recruitment but also demonstrating that the OMM treatment can be effectively administered in a clinical trial setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report of a clinical trial on the duration of middle ear effusion in young children using a standardized osteopathic manipulative medicine protocol. Steele, KM., Viola, J., Burns, E., et al.[2010]

Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) showed a significant improvement in pharyngeal stability for patients with obstructive sleep apnea, with 5 out of 7 patients responding positively after active manipulation compared to none after sham manipulation.

The study demonstrated the feasibility of a randomized, controlled, double-blind design for evaluating OMT, although it highlighted the need for larger studies to further assess its efficacy on the apnoea-hypopnoea index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study. Jacq, O., Arnulf, I., Similowski, T., et al.[2018]

A systematic review of 12 studies involving 367 participants found moderate-quality evidence that osteopathic manipulative treatment (OMT) significantly reduces disability, severity, and frequency of dizziness associated with neuro-otologic disorders.

Despite the positive findings, the evidence should be interpreted cautiously due to high risk of bias and small sample sizes in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of osteopathic manipulative techniques on the management of dizziness caused by neuro-otologic disorders: systematic review and meta-analysis. Rehman, Y., Kirsch, J., Wang, MY., et al.[2023]

Cranial osteopathic manipulative medicine (OMM) shows potential benefits in reducing pain, improving sleep patterns, and enhancing autonomic nervous system function based on a review of 8 studies, including 7 randomized controlled trials.

However, the evidence is heterogeneous and of moderate quality, indicating that more rigorous research is necessary to establish definitive conclusions about the efficacy of cranial OMM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. Jäkel, A., von Hauenschild, P.[2022]

A study involving 35 fourth-year osteopathic medical students showed that increased clinical exposure to osteopathic manipulative medicine (OMM) significantly improved their understanding and comfort levels in discussing, explaining, and performing OMM techniques.

After a 4-week elective OMM rotation, students reported notable increases in confidence regarding their ability to incorporate OMM into their future medical practice, indicating that hands-on experience is crucial for effective training in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Clinical Exposure to Osteopathic Manipulative Medicine on Confidence Levels of Medical Students. Shapiro, LN., Defoe, D., Jung, MK., et al.[2022]

Citations

1. researchgate.net researchgate.net/topic/Osteopathic-Manipulation~Plagiocephaly/publications

Osteopathic Manipulation and Plagiocephaly Background Several studies showed the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay in hospital, gastrointestinal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9369972/

Osteopathic Manipulative Treatment for Pediatric Conditions Osteopathic manipulative treatment (OMT) continues to be used for a range of diseases in children. Objectives: The aim of this paper is to ...

3. osteopathiccenter.org osteopathiccenter.org/opt-in-study-for-providers/

OPT-IN Study for Providers This is a two-arm, randomized cross-over clinical trial looking at the benefit of osteopathic manipulative treatment (OMT) in the management of deformational/ ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/95/NCT03970395/Prot_SAP_000.pdf

Effectiveness of Osteopathic Manipulative Therapy in ... Osteopathic manipulative medicine is a form of manual therapy used to diagnose and treat somatic dysfunction, normalize the structure- function ...

5. scribd.com scribd.com/document/689786556/Effects-of-osteopathic-manipulative-treatment-on-children-with-plagiocephaly-in-the-context-of-current-pediatric-practice-a-retrospective-chart-revi

Effects of Osteopathic Manipulative Treatment On Children ... This study investigated the effects of osteopathic manipulative treatment (OMT) on children with deformational plagiocephaly (DP).

6. osteopathicboard.org osteopathicboard.org/wp-content/uploads/2020/09/The-Pocket-Manual-of-OMT-Osteopathic-Manipulative-Treatment-for-Physicians.pdf

Pocket Manual of OMT The pocket manual of OMT: osteopathic manipulative treatment for physicians/editor, co-author,. David R. Beatty ... [et al.].—2nd ed.

7. osteobcn.com osteobcn.com/wp-content/uploads/2016/04/5435ae8b0cf2643ab9867e20.pdf

Exploring the impact of osteopathic treatment on cranial ... Osteopathic manipulative therapy (OMTh) is defined as a therapeutic application of manually guided forces by an osteopath (non-physician) to improve physio-.

8. acofp.org acofp.org/news-and-publications/journal/article-detail/vol-12-no-6-(2020)-november-december-2020/osteopathic-manipulative-treatments-pediatric-conditions

Osteopathic Manipulative Treatments for Pediatric Conditions Osteopathic manipulative treatment is considered generally safe for use in the pediatric patient, but again, more studies are needed to give statistical proof ...