Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

NCT01559948 | Completed Results

• 1 other identifier: 16931
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized clinical trial is to examine the usefulness of the addition of a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to lumbopelvic stabilization exercises alone. Outcome measures including the Modified Oswestry Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement using the Global Rating of Change (GROC) scale will be collected. Hypothesis: The OSW scores and NPRS scores will be lower for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone. The percent change of muscle thickness for the deep abdominals as well as the GROC scores will be higher for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone.

Conditions

Low Back Pain

Keywords

Low back pain; Sacroiliac joint pain; Lumbopelvic stabilization program; Pelvic compression belt; Deep abdominal muscles

Outcome Measures

Primary Outcomes (1)

• Oswestry Low Back Pain Questionnaire

  The Modified Oswestry Back Pain Questionnaire(OSW) will be used to determine Low back pain-related disability. The OSW consists of 10 items assessing different aspects of pain and function related to LBP. Each item is scored 0-5. The item scores are summed and multiplied by 2 to get the total disability score. The total score reported can range from 0-100 with 0 representing no disability and higher scores representing greater disability.

  Baseline, 4 weeks, 12 weeks

Secondary Outcomes (4)

• Numeric Pain Rating Scale (NPRS)

  Baseline, 4 weeks, 12 weeks

• Percent Change of Muscle Thickness for the Transverse Abdominis (TrA)

  Baseline, 4 weeks, 12 weeks

• Change in Global Rating of Change (GROC) Scale

  4 weeks, 12 weeks

• Percent Change of Muscle Thickness for Internal Oblique

  Baseline, 4 weeks, 12 weeks

Study Arms (2)

Lumbopelvic stabilization exercises plus sacroiliac joint belt

EXPERIMENTAL

The participants will be instructed in the lumbopelvic stabilization program. Additionally, during the initial session, these participants receive a sacroiliac compression belt and be instructed to wear the belt during all waking hours for the first four weeks of the study.

Behavioral: Lumbopelvic stabilization exercise; Device: Sacroiliac joint belt

Lumbopelvic stabilization exercise

ACTIVE COMPARATOR

The participants will be instructed in the lumbopelvic stabilization program.

Behavioral: Lumbopelvic stabilization exercise

Interventions

Lumbopelvic stabilization exercise BEHAVIORAL

The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine. Participants will complete 4 different exercises daily: one in supine, one in standing, one in quadruped, and one in a side-bridge position. The dosage for each exercise is 20 reps with an 8 second hold. In supine, the first exercise is the abdominal drawing-in maneuver. In standing, the first exercise is the abdominal drawing-in maneuver. In quadruped, the first exercise is alternating arm lifts. The final exercise is the side-bridge hold. Participants will then be asked to attend supervised physical therapy sessions twice a week for 2 weeks and once a week for another 2 weeks. They will be instructed to perform the exercises at home daily for a total of 12 weeks as well as complete a compliance log. Progression of the stabilization program will be determined by the physical therapist based on pre-established criteria.

Lumbopelvic stabilization exercise; Lumbopelvic stabilization exercises plus sacroiliac joint belt

Sacroiliac joint belt DEVICE

The belt should be worn low around the pelvis just above the greater trochanter and instructed to wear the belt during all waking hours of the first four weeks of the study. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt.

Lumbopelvic stabilization exercises plus sacroiliac joint belt

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral pain near the sacroiliac joint that does not extend pass the knee
• positive result on 2 of 6 sacroiliac joint provocation tests:
• compression test
• distraction test
• posterior shear test
• Gaenslens' test (left and right)
• sacral thrust test

You may not qualify if:

• current pregnancy or pregnancy in the last 6 months
• history of surgery to lumbar spine, pelvis, chest, abdomen
• history of congenital lumbar or pelvic anomalies
• any neurological signs in the lower extremity

Sponsors & Collaborators

• Texas Woman's University: lead
• Texas Physical Therapy Association: collaborator

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, 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

Results Point of Contact

• Title: Dr. Kelli Brizzolara
• Organization: Texas Woman's University

kbrizzolara@twu.edu

214-689-7722

Study Officials

• Kelli J Brizzolara, MS

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate student

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: March 21, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)