Soft Tissue Mobilization for Lumbopelvic Pain in the Third Trimester of Pregnancy (STM)

T

Texas Tech University Health Sciences Center

Status

Completed

Conditions

Pregnancy
Low Back Pain

Treatments

Procedure: Soft Tissue Massage
Procedure: Soft Tissue Mobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT03433404
L17-191

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

26 participants in 3 patient groups

Soft Tissue Mobilization
Experimental group
Description:
The arm will utilize a Physical Therapy technique call soft tissue mobilization.
Treatment:
Procedure: Soft Tissue Mobilization
Soft Tissue Massage
Active Comparator group
Description:
This arm will utilize standard soft tissue massage applied to the low back in pregnant patients complaining of third trimester low back pain.
Treatment:
Procedure: Soft Tissue Massage
No manual treatment
No Intervention group
Description:
Group will still receive acetaminophen, heating pad application, and/or rest which is standard of care.

Trial contacts and locations

1

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Central trial contact

Phil Sizer, PhD; Russell F Stanley, DO

Data sourced from clinicaltrials.gov

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