Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum

NCT ID: NCT06560190

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2025-07-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Pregnancy Related

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Postpartum Study Participant

Pragmatic Orthopaedic Physical Therapy

Group Type EXPERIMENTAL

Orthopaedic Manual Physical Therapy

Intervention Type OTHER

Individualized Treatment

Interventions

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Orthopaedic Manual Physical Therapy

Individualized Treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Casey Shutt-Hoblet

MAJ Casey Shutt-Hoblet, PT, DPT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Casey Shutt-Hoblet, DPT

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

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Brooke Army Medical Center

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Casey Shutt-Hoblet, DPT

Role: CONTACT

210-808-2226

Facility Contacts

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Casey Shutt-Hoblet, DPT

Role: primary

210-808-2226

References

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Iobst SE, Smith DC, Best NI, Allard RJ, Trego LL. A Scoping Review of Pregnancy, Childbirth, and the Postpartum Period in Active Duty U.S. Military Women. Womens Health Issues. 2021 Aug 25;31 Suppl 1:S81-S92. doi: 10.1016/j.whi.2020.05.005.

Reference Type BACKGROUND
PMID: 34454706 (View on PubMed)

Miller MJ, Kutcher J, Adams KL. Effect of Pregnancy on Performance of a Standardized Physical Fitness Test. Mil Med. 2017 Nov;182(11):e1859-e1863. doi: 10.7205/MILMED-D-17-00093.

Reference Type BACKGROUND
PMID: 29087853 (View on PubMed)

Weina SU. Effects of pregnancy on the Army Physical Fitness Test. Mil Med. 2006 Jun;171(6):534-7. doi: 10.7205/milmed.171.6.534.

Reference Type BACKGROUND
PMID: 16808137 (View on PubMed)

DeGroot DW, Sitler CA, Lustik MB, Langan KL, Hauret KG, Gotschall MH, Gehrich AP. The effect of pregnancy and the duration of postpartum convalescence on the physical fitness of healthy women: A cohort study of active duty servicewomen receiving 6 weeks versus 12 weeks convalescence. PLoS One. 2021 Jul 28;16(7):e0255248. doi: 10.1371/journal.pone.0255248. eCollection 2021.

Reference Type BACKGROUND
PMID: 34320030 (View on PubMed)

Armitage NH, Smart DA. Changes in Air Force fitness measurements pre- and post-childbirth. Mil Med. 2012 Dec;177(12):1519-23. doi: 10.7205/milmed-d-12-00248.

Reference Type BACKGROUND
PMID: 23397699 (View on PubMed)

ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

Reference Type BACKGROUND
PMID: 29683911 (View on PubMed)

Doran F, Davis K. Factors that influence physical activity for pregnant and postpartum women and implications for primary care. Aust J Prim Health. 2011;17(1):79-85. doi: 10.1071/PY10036.

Reference Type BACKGROUND
PMID: 21616029 (View on PubMed)

Selman R, Early K, Battles B, Seidenburg M, Wendel E, Westerlund S. Maximizing Recovery in the Postpartum Period: A Timeline for Rehabilitation from Pregnancy through Return to Sport. Int J Sports Phys Ther. 2022 Oct 1;17(6):1170-1183. doi: 10.26603/001c.37863. eCollection 2022.

Reference Type BACKGROUND
PMID: 36237644 (View on PubMed)

Christopher, S.M., et al., Rehabilitation of the Postpartum Runner: A 4-Phase Approach. Journal of Women's Health Physical Therapy, 2022. 46(2): p. 73-86.

Reference Type BACKGROUND

Other Identifiers

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PT4Postpartum

Identifier Type: -

Identifier Source: org_study_id

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