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

NCT03433404 | Completed

• 1 other identifier: L17-191
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Pain using NPRS (Numerical Pain Rating Scale)

  The NPRS is a scale from 0 to 10 that is commonly used to measure intensity of pain, with 0 representing no pain and 10 representing extreme pain. It is easy to understand and complete that is also valid and reliable. Due to the nature of fluctuating intensity of pain, subjects will use a NPRS to log their current pain, least pain, and most pain each day at home and at the obstetric clinic before the respective treatment. The daily pain score will be averaged, then averaged across each week. The NPRS scores will be also be used to evaluate the change between the overall pain level at the beginning and end of subject's participation. The aim throughout the study is to see a reduction in the overall numerical pain scale rating. For example, if a patient comes in with a pain scale rating of 10, the hope is that after a series of treatments, the pain scale will go down to indicate an improvement in overall pain.

  through study completion, an average of 1 year

• disability using ODI (Oswestry Disability Index)

  Back pain and its effect on disability can be evaluated using the ODI. It is a brief 10 question survey on the effect of back pain on daily activities, such as personal care, walking, lifting, sitting, standing, sex life, social life, traveling. Each answer in each section is scored 0 to 5, 0 if the first box is checked (0 if it causes no disability) and 5 (maximal disability) if the last box is checked. The final score is expressed as a percentage out of a total score of 50. It is usually used for lumbar back pain, but has been shown to be specifically valid for sacroiliac joint pain. The ODI questionnaire will be filled out by subjects at the initial session and at the end of the final treatment session.

  through study completion, an average of 1 year

Study Arms (3)

Soft Tissue Mobilization

EXPERIMENTAL

The arm will utilize a Physical Therapy technique call soft tissue mobilization.

Procedure: Soft Tissue Mobilization

Soft Tissue Massage

ACTIVE COMPARATOR

This arm will utilize standard soft tissue massage applied to the low back in pregnant patients complaining of third trimester low back pain.

Procedure: Soft Tissue Massage

No manual treatment

NO INTERVENTION

Group will still receive acetaminophen, heating pad application, and/or rest which is standard of care.

Interventions

Soft Tissue Mobilization PROCEDURE

The technique has been described previously in other descriptions. However, the main goal of this treatment is to address the LDSIL in the manner described previously in order to mobilize the soft tissue in the area.

Soft Tissue Mobilization

Soft Tissue Massage PROCEDURE

For sMass, the subject will be positioned on her side opposite to the most painful side of the lumbosacral spine with the hips flexed to 45 degrees and knees flexed to 90 degrees (with a pillow positioned between them). The investigator will perform superficial (light stroke) massage to the painful side of the lumbosacral region for 5 minutes

Soft Tissue Massage

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Inclusion Criteria: (1) Subjects 18-45 years old with (2) singleton gestation in the third trimester (28 weeks and on); (3) pregnancy-related lumbopelvic pain; and (4) capable of following basic instructions. Exclusion Criteria: (1) Subjects with a history of lumbopelvic pain that required healthcare management within a year prior to pregnancy, (2) acute infectious or inflammatory process, (3) diagnosed mental health disorder; (4) substance abuse; (5) documented diagnosis of fibromyalgia.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 14, 2018
• Study Start: December 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 14, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)