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

Trial Summary

What is the purpose of this trial?

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: 1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. 2. 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.

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.

What data supports the effectiveness of the treatment Osteopathic Manipulative Treatment (OMT) for Flat Head Syndrome?

Research suggests that osteopathic manipulative medicine (OMM), which includes techniques like OMT, can improve structure and function in both children and adults, indicating potential benefits for conditions like Flat Head Syndrome. ^{1 2 3 4 5}

Is osteopathic treatment generally safe for humans?

Osteopathic manipulative treatment (OMT) has been used for over a century by osteopathic physicians for various conditions, and it is generally considered safe for humans. However, specific safety data for flat head syndrome is not provided in the available research. ^{1 2 4 6 7}

How is the treatment for flat head syndrome different from other treatments?

Osteopathic Manipulative Treatment (OMT) is unique because it involves hands-on techniques to improve body structure and function, which is different from standard repositioning that focuses on changing the baby's position to reshape the head. ^{1 5 6 8 9}

Research Team

Kimberly J Wolf, DO

Principal Investigator

Osteopathy's Promise to Children

Eligibility Criteria

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 a diagnosed genetic syndrome.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Characteristics and treatment of geriatric patients in an osteopathic neuromusculoskeletal medicine clinic. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Characteristics and Treatment of Pediatric Patients in an Osteopathic Manipulative Medicine Clinic. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Clinical Exposure to Osteopathic Manipulative Medicine on Confidence Levels of Medical Students. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Osteopathic medical students' beliefs about osteopathic manipulative treatment at 4 colleges of osteopathic medicine. [2022]

6. Germany 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. [2023]

7. United States 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. [2010]

8. England 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. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Awareness and interest in osteopathic manipulative treatment in allopathic medical students. [2023]