Clinical trial NCT03433404: Soft Tissue Mobilization for Lumbopelvic Pain in the Third Trimester of Pregnancy
Official title: Soft Tissue Mobilization for Lumbopelvic Pain in the Third Trimester of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Pregnancy
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Back pain is one of the most common complaints in pregnancy. It is caused by the growing pregnant abdomen which then strains the lower back and pelvis. Often Obstetricians recommend rest, Tylenol, pelvic support belts, or exercise. Typically, these do not provide the patient much relief. A physical therapy treatment known as soft tissue mobilization (tSTM) has been shown to be helpful in treating various types of pain. This study will explore whether tSTM can improve back pain in pregnancy.

Detailed description: Context: Lumbopelvic pain is one of the most common complaints in pregnancy, as increasing hormone levels cause joint laxity and the gravid uterus weakens abdominal muscles and increases lumbar muscle strain. Obstetricians often recommend rest, exercise, heating pad application, acetaminophen, or pelvic support belts. Patients often complain of minimal relief from these recommendations. Many experience recurrent lumbopelvic pain in a subsequent pregnancy. Additionally, lumbopelvic pain can contribute to disability and sick leave during the pregnancy. This is the first study to investigate whether soft tissue mobilization improves lumbopelvic pain in the third trimester.

Objective: To investigate whether a physical therapy intervention known as transverse friction massage or soft tissue mobilization improves third trimester pregnancy related lumbopelvic pain.

Design: Randomized pre-test and post-test comparison group design. Setting: Texas Tech University Health Sciences Center, Center for Rehabilitation Research, Lubbock, TX, USA.

Participants: 48 subjects between the 18-45 years of age with a singleton gestation in the third trimester with pregnancy related lumbopelvic pain.

Methods: Subjects consented for the study will be diagnosed by the Obstetrician with PRLPP by clinical tests, including the posterior pelvic pain provocation test, active straight leg raise test, and the long dorsal sacroiliac ligament test. Subjects will be randomized to one of three groups: no manual treatment (noManRx), superficial massage (sMass), and soft tissue mobilization (tSTM). All groups will receive standard care, which includes acetaminophen, heating pad application, and/or rest. Subjective questionnaires including the numeric pain rating scale (NPRS), the Oswestry Disability Index (ODI), and the Global Rating of Change (GROC) will be administered for baseline prior to allocated intervention. The Pressure Pain Threshold (PPT) will be measured via algometry. Those receiving sMass and tSTM will receive prescribed standard care as well as sMass or tSTM every 1-2 weeks by an investigator as well as daily sMass or tSTM at home.

Main outcome measures: (1) Pain using NPRS, (2) disability using ODI, (3) overall change in pain pre- and post-treatment using GROC, (4) pressure pain threshold via algometry.

Expected results: It is anticipated that this soft tissue mobilization technique known as transverse friction massage will decrease lumbopelvic pain in the third trimester of pregnancy.

Eligibility criteria: Inclusion Criteria:Inclusion Criteria:

* Subjects 18-45 years old
* singleton gestation in the third trimester (28 weeks and on)
* pregnancy-related lumbopelvic pain
* capable of following basic instructions.

Exclusion Criteria:

* Subjects with a history of lumbopelvic pain that required healthcare management within a year prior to pregnancy
* acute infectious or inflammatory process
* diagnosed mental health disorder
* substance abuse
* documented diagnosis of fibromyalgia.

Primary outcomes:
measure: Pain using NPRS (Numerical Pain Rating Scale)
timeFrame: through study completion, an average of 1 year
measure: disability using ODI (Oswestry Disability Index)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References: