Manual Physical Therapy for Postpartum Care

Overseen By Casey Shutt-Hoblet, DPT

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Brooke Army Medical Center

Disqualifiers: Orthopaedic treatment, Military separation, Hysterectomy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Orthopaedic Manual Physical Therapy (a specialized physical therapy focusing on movement and muscles) can help postpartum military women safely return to physical activity. Many women face increased injury risks in the first year after giving birth, especially when preparing for mandatory fitness tests. The trial seeks to address the lack of guidance provided to postpartum women on resuming exercise. Active-duty service members who are between 6 weeks and 6 months postpartum and have been cleared by their doctor to start physical activity may be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could benefit postpartum women in the military.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Orthopaedic Manual Physical Therapy is safe for postpartum care?

Research shows that Orthopaedic Manual Physical Therapy (OMPT) is a safe treatment for women after childbirth. This therapy improves muscle and joint function and often aids recovery from surgeries and injuries. Studies have found it effective in reducing pain and enhancing movement, particularly in the lower back and pelvis after childbirth.

OMPT practitioners receive training to address both simple and complex muscle and joint issues. No evidence of serious side effects from OMPT in postpartum women indicates it is well-tolerated. This makes it a promising option for women seeking a safe return to physical activity after childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Orthopaedic Manual Physical Therapy is unique because it offers a hands-on approach to postpartum care, focusing on personalized, manual techniques to address musculoskeletal issues that new mothers may experience. Unlike standard postpartum treatments, which often rely on general exercise programs or medications, this therapy can be tailored to the individual's specific physical needs, potentially offering more immediate and targeted relief. Researchers are excited about this method because it emphasizes a non-invasive, drug-free approach, potentially reducing the need for medication and its associated side effects, while promoting faster recovery and improved physical function for postpartum women.

What evidence suggests that Orthopaedic Manual Physical Therapy is effective for postpartum care?

Research has shown that Orthopaedic Manual Physical Therapy (OMPT), which participants in this trial will receive, offers promise for new mothers dealing with muscle and joint issues. Studies indicate that physical therapy exercises focusing on strengthening the core and pelvic area effectively treat lower back and pelvic pain after childbirth. This therapy reduces pain, lessens disability, and shortens time away from work. Digital physical therapy has also received positive feedback and helps manage these symptoms. Overall, OMPT can help new mothers safely become more active and improve their quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Casey Shutt-Hoblet, DPT

Principal Investigator

Brooke Army Medical Center

Are You a Good Fit for This Trial?

This trial is for postpartum military women who are facing challenges in returning to physical activity and need to pass fitness tests for career advancement. It aims to help those who have not received guidance on resuming exercise after childbirth.

Inclusion Criteria

Postpartum >6 weeks and <6 months

I am a female currently serving in the military.

My OBGYN has cleared me to start exercising after giving birth.

Exclusion Criteria

Separating from military service in the next 6 months

Peripartum Hysterectomy

I am currently seeing a physical therapist for bone or muscle issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive orthopaedic physical therapy management for postpartum care over an 8-week period

8 weeks

Minimum of 3 visits (in-person)

Follow-up

Participants are monitored for changes in health-related quality of life, pain, and physical activity levels

4 weeks

2 visits (in-person)

Optional Continuation

Participants may choose to continue physical therapy intervention with their treating provider after the study

What Are the Treatments Tested in This Trial?

Interventions

• Orthopaedic Manual Physical Therapy

Trial Overview The study is testing the effectiveness of Orthopaedic Manual Physical Therapy (OMPT) in helping postpartum women return to physical activity, potentially improving their musculoskeletal health and quality of life.

How Is the Trial Designed?

Group I: Postpartum Study Participant Experimental Treatment 1 Intervention

Pragmatic Orthopaedic Physical Therapy

Orthopaedic Manual Physical Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Orthopaedic Manual Physical Therapy for:

• Musculoskeletal symptoms postpartum
• Return to physical activity postpartum
• Prevention of musculoskeletal injuries postpartum

Approved in European Union as Orthopaedic Manual Physical Therapy for:

• Postpartum musculoskeletal rehabilitation
• Prevention of postpartum musculoskeletal injuries
• Improvement of physical fitness postpartum

Approved in Canada as Orthopaedic Manual Physical Therapy for:

• Postpartum physical therapy for musculoskeletal symptoms
• Return to physical activity postpartum
• Prevention of postpartum musculoskeletal injuries

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

Published Research Related to This Trial

In a study of 1310 osteopathic manipulative medicine (OMM) consultations, 47% were for musculoskeletal complaints, with back pain being the most common reason, indicating a strong focus on treating physical pain in hospitalized patients.

A significant portion of consultations (27%) were for newborn feeding difficulties, suggesting that OMT may also be beneficial for pediatric patients, but overall awareness among physicians about its broader applications, including respiratory issues and postoperative recovery, appears limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Medicine Consultations for Hospitalized Patients. Levy, VJ., Holt, CT., Haskins, AE.[2022]

A study involving 668 patients across 11 clinics showed that osteopathic manual treatment (OMT) is frequently used for musculoskeletal issues, with techniques like cranial and myofascial release being the most common.

The research highlights that patient demographics, such as age and sex, influence the likelihood of receiving specific OMT techniques, indicating a tailored approach in osteopathic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study. Licciardone, JC., Kearns, CM., King, HH., et al.[2014]

A study involving 68,960 women found that those who used orthopedic manual therapy (OMT) before pregnancy had a significantly lower risk of developing low back pain (LBP) during pregnancy, with an adjusted odds ratio of 0.86.

Women who used OMT with high intensity prior to pregnancy experienced nearly a 30% reduction in LBP during pregnancy, suggesting that OMT could be a beneficial preventive measure for pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased Risk of Low Back Pain During Pregnancy Associated With the Use of Orthopedic Manual Therapy: A Nested Case-Control Study. Chang, WC., Livneh, H., Yen, CT., et al.[2022]

In a study involving 884 patients, the incidence of adverse events immediately after osteopathic manipulative treatment (OMT) was found to be low at 2.5%, with pain or discomfort being the most common complaint.

Women reported experiencing adverse events more frequently than men, suggesting a potential demographic factor in the response to OMT, but overall, the rate of adverse events was lower than those reported in other manual therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. Degenhardt, BF., Johnson, JC., Brooks, WJ., et al.[2022]

A Delphi study involving 164 expert manual therapy educators established consensus on 19 key themes for training in orthopaedic manual therapy (OMT), emphasizing a patient-centered approach within a biopsychosocial pain management model.

The study highlighted the importance of integrating neurophysiological, psychological, and biomechanical principles into OMT education, suggesting a need to restructure training curricula to align with evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modernizing patient-centered manual therapy: Findings from a Delphi study on orthopaedic manual therapy application. Keter, D., Griswold, D., Learman, K., et al.[2023]

A survey of 39 international Orthopaedic Manual Therapy (OMT) educational programs revealed that 61.5% have implemented the 2020 International IFOMPT Cervical Framework aimed at improving safety in cervical assessments before OMT.

Despite the successful dissemination of the Framework, many programs (33.3% for middle/lower cervical spine and 25.5% for upper cervical spine) continue to teach end range manipulations, raising concerns about adherence to updated safety guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the International IFOMPT Cervical Framework: A survey among educational programmes. Hutting, N., Kranenburg, R., Taylor, A., et al.[2022]

A survey of 1640 students and recent graduates from orthopaedic manipulative physical therapy programs revealed that 60% reported no adverse effects from manual therapy training, while 40% experienced issues, primarily neck pain (66.4%), headaches (50.9%), and low back pain (32%).

Most adverse effects were mild to moderate and typically resolved within 24 hours, but the study also highlighted a concerning occurrence of major adverse effects that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects as a consequence of being the subject of orthopaedic manual therapy training, a worldwide retrospective survey. Thoomes-de Graaf, M., Thoomes, EJ., Carlesso, L., et al.[2018]

Only 37.6% of the 364 surveyed physical therapists in Taiwan reported having experience treating pregnancy or postpartum-related disorders, with low back pain being the most common issue addressed (61.3%).

Despite a positive attitude towards antepartum and postpartum care, most therapists expressed low confidence in managing these disorders, primarily due to a significant barrier of 'lack of available training' (81.3%), indicating a need for improved education in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' experiences and perceptions of antepartum and postpartum care. Lin, KY., Tsai, YJ., Yang, JF., et al.[2022]

Orthopaedic manual therapy (OMT) is a recognized professional qualification in physiotherapy in Belgium, aimed at treating neuromusculoskeletal dysfunctions, yet it remains underrecognized by both patients and healthcare professionals.

There is a growing body of scientific evidence supporting the effectiveness of OMT, which utilizes specific treatments based on clinical reasoning and the individual characteristics of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Orthopaedic manual therapy : definition, characteristics and update on the situation in Belgium]. Demoulin, C., Depas, Y., Vanderthommen, M., et al.[2018]

Citations

1. trialx.com trialx.com/clinical-trials/listings/301321/orthopaedic-manual-physical-therapy-as-part-of-the-postpartum-care-continuum/

Orthopaedic Manual Physical Therapy as Part of the ... Data shows us that injury risk increases in the first year postpartum. There is a paucity of literature regarding MSK injuries in postpartum ...

2. smartpatients.com smartpatients.com/trials/NCT06560190

Orthopaedic Manual Physical Therapy as Part of the ... Data shows us that injury risk increases in the first year postpartum. There is a paucity of literature regarding MSK injuries in postpartum military women.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12446167/

Pregnancy-Related Hip and Pelvis Musculoskeletal ... Exercise-based physical therapy including core and pelvic stability exercises are an effective treatment option for postpartum lumbopelvic ...

4. researchgate.net researchgate.net/publication/358921267_Physical_Therapy_Is_an_Important_Component_of_Postpartum_Care_in_the_Fourth_Trimester

Physical Therapy Is an Important Component of ... Conclusion Digital physiotherapy was well-accepted and perceived as beneficial for managing musculoskeletal symptoms during pregnancy and after childbirth.

5. jospt.org jospt.org/doi/10.2519/jospt.2014.5098

Recommendations for Physical Therapists on the ... Treating lumbopelvic pain during pregnancy with this form of therapy generally yielded better results on pain, disability, and sick leave than ...

6. aaompt.org aaompt.org/common/Uploaded%20files/DASP_October_2018.pdf

Orthopaedic Manual Physical Therapy Description of ... Practitioners of OMPT provide patient management, consult with other health care providers regarding simple as well as complex neuromusculoskeletal (NMS).

7. researchgate.net researchgate.net/publication/378829103_Orthopaedic_Manual_Physical_Therapy_A_Modern_Definition_and_Description

(PDF) Orthopaedic Manual Physical Therapy: A Modern ... This perspective provides a current definition and conceptual model of OMPT, defining the distinguishing characteristics and key elements of this systematic ...