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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    75
  • sponsor
    Texas Tech University Health Sciences Center
Updated on 28 February 2022
back pain
massage
physical therapy treatment
Accepts healthy volunteers

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.

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.

Details
Condition Low Back Pain, Pregnancy
Treatment Soft Tissue Mobilization, Soft Tissue Massage
Clinical Study IdentifierNCT03433404
SponsorTexas Tech University Health Sciences Center
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note