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NCT Number: NCT06560190

Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum

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.

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Key information

Conditions

Postpartum Behavior Motor Activity Pregnancy Related

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location status: Recruiting

Location contact

Casey Shutt-Hoblet, DPT

CONTACT

[email protected]

210-808-2226

About this study

The purpose of this study is to 1) Describe changes in health-related quality of life in postpartum women following eight weeks of orthopaedic physical therapy management as part of the postpartum care continuum for active-duty service members 2) Describe changes in pain and physical activity levels following eight-weeks of OMPT management in this same sample and 3) Determine whether select patient characteristics associated with improvement physical function scores following this same eight-week program of OMPT.

This is a Quasi-experimental one-group repeated measures study. Participants who meet the inclusion criteria will be evaluated by board certified orthopedic physical therapist who is a fellow-in-training.The initial evaluation and treatment will be provided over an 8 week period with a minimum of 3 visits. The treatment approach will be initiated at the initial visit and will be based on standard of care OMPT treatment and existing rehab frameworks for postpartum pelvic girdle pain, low back pain and return to physical activity.

At the 8-week time point, participants will complete final outcomes tools. Participants will be discharged from the study, but they can choose to continue physical therapy intervention with their treating provider if they desire. Data beyond the 8-week mark will not be saved for the research trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female Active-Duty Service Member
  • Postpartum >6 weeks and <6 months
  • Cleared by OBGYN at postpartum follow-up to initiate physical activity

Exclusion criteria

  • Current or ongoing treatment by an orthopaedic physical therapist
  • Separating from military service in the next 6 months
  • Current permanent profile for a musculoskeletal condition
  • Peripartum Hysterectomy

Treatment and study plan

Orthopaedic Manual Physical Therapy

Other

Individualized Treatment

Primary outcomes

  1. 36-Item Short Form Survey Instrument (SF36)

    Time frame: Baseline, 4 weeks and 8 weeks

    The 36-Item Short Form Survey Instrument (SF 36) is the most widely used quality of life tool in the postpartum population. The lowest score on each subscale is zero and the highest score on each subscale is 100. A higher score is better.

Secondary outcomes

  1. International Physical Activity Questionnaire- Short Form (IPAQ)

    Time frame: Baseline, 4 weeks and 8 weeks

    We will use the International physical activity questionnaire short form to assess physical activity level. The lowest score is zero and the highest score is not identified although scores over 16 hours of physical activity per day should be excluded as an outlier. A higher score is better.

  2. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline, 4 weeks and 8 weeks

    The Numeric Pain Rating Scale (NPRS) will be used to measure pain.The lowest score is 0 and the highest score is 10. A lower score is better.

  3. Cozean Pelvic Dysfunction Screening Protocol

    Time frame: Baseline, 4 weeks and 8 weeks

    Orthopaedic physical therapists should utilize the Cozean protocol to screen which patients need a pelvic floor rehab referral following the DHA practice recommendation for Pelvic Health and Postpartum Rehabilitation Services. The lowest score is zero and highest score is 10. A higher score does not indicate more dysfunction. A cutoff of 3 is applied to indicate a referral is needed for pelvic floor physical therapy.

  4. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Baseline

    This tool will be used in accordance with the DHA Practice Recommendation for Behavioral Health Screening and Referral in Pregnancy and Postpartum at the initial evaluation to screen for depression in postpartum patients. The lowest score is zero and highest score is thirty. A higher score is worse and indicates need for behavioral health referral.

Study contacts

Contact information is provided by the study sponsor or research team.

Casey Shutt-Hoblet, DPT

CONTACT

[email protected]

210-808-2226

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum for Active-Duty Service Members

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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