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

Trial Summary

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 data supports the effectiveness of the treatment Orthopaedic Manual Physical Therapy for postpartum care?

Research shows that osteopathic manipulative treatment, which is similar to orthopaedic manual therapy, has been beneficial in improving postpartum recovery. Additionally, orthopaedic manual therapy has been recognized for its effectiveness in treating musculoskeletal issues, which are common after childbirth. ^{1 2 3 4 5}

Is manual physical therapy generally safe for postpartum care?

Manual physical therapy, including orthopaedic manual therapy, is generally considered safe, but rare adverse events have been reported in the literature. These events are usually minor and can occur during training or treatment for various conditions. ^{1 5 6 7 8}

How is Orthopaedic Manual Physical Therapy (OMPT) different from other postpartum treatments?

Orthopaedic Manual Physical Therapy (OMPT) is unique because it involves hands-on techniques specifically tailored to address neuromusculoskeletal issues, using clinical reasoning and evidence-based practices to cater to each patient's individual needs. Unlike standard treatments, OMPT is recognized for its specialized approach and has been shown to reduce the risk of conditions like low back pain, which is common during and after pregnancy. ^{1 4 5 6 9}

What is the purpose of this trial?

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. A unique challenge that postpartum service members face is the increased stress of training for and having to pass a physical fitness test directly tied to their career advancement. While there is epidemiological data across multiple branches of service, there is a gap in the literature in terms of how to appropriately address these decreased fitness levels and better understand the root causes. American College of Gynecology (ACOG) recommends that the postpartum visit include actionable information on return to physical activity. However, a large majority of women report receiving no guidance on how to engage in physical activity during pregnancy and in the postpartum period. Physical therapy is commonly used to help individuals return to physical activity following orthopaedic surgeries, but it is not frequently utilized to assist the postpartum population in progressing back to physical activity. Orthopaedic Manual Physical Therapists (OMPTs) are uniquely trained to address musculoskeletal symptoms and progress physical activity. An OMPT evaluation and treatment could facilitate increased physical activity and improve health-related quality of life, supporting the ACOG recommendation to make postpartum care an ongoing multidisciplinary process.

Research Team

Casey Shutt-Hoblet, DPT

Principal Investigator

Brooke Army Medical Center

Eligibility Criteria

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

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

Separating from military service in the next 6 months

I have a long-term muscle or bone condition.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of the International IFOMPT Cervical Framework: A survey among educational programmes. [2022]

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

Osteopathic Manipulative Medicine Consultations for Hospitalized Patients. [2022]

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

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study. [2014]

4. Switzerland 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. [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Orthopaedic manual therapy : definition, characteristics and update on the situation in Belgium]. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse effects as a consequence of being the subject of orthopaedic manual therapy training, a worldwide retrospective survey. [2018]

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

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Modernizing patient-centered manual therapy: Findings from a Delphi study on orthopaedic manual therapy application. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Physical therapists' experiences and perceptions of antepartum and postpartum care. [2022]