Clinical trial NCT06560190: Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum
Official title: Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum for Active-Duty Service Members
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum
Pregnancy Related
Keywords: Postpartum
Physical Activity
Pregnancy
Service Member
Physical Therapy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2024-08-19
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 36-Item Short Form Survey Instrument (SF36)
timeFrame: Baseline, 4 weeks and 8 weeks
Secondary outcomes:
measure: International Physical Activity Questionnaire- Short Form (IPAQ)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Cozean Pelvic Dysfunction Screening Protocol
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Casey Shutt-Hoblet, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
citation: 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.
citation: 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.
citation: 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.