Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

A Randomized Clinical Trial of the Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Lumbopelvic stabilization exercise; Device: Sacroiliac joint belt

Detailed Description

Background: The estimated prevalence of sacroiliac joint (SIJ) pain is approximately 13-30% in patients with non-specific low back pain. One common presentation for those with SIJ pain is unilateral pain over the SIJ region, which is described as a positive Fortin's sign. Common impairments for this population include pelvic asymmetry, lumbopelvic muscle imbalance, and decreased lumbopelvic proprioceptive awareness and stability. Two common physical therapy interventions for this population are lumbopelvic stabilization programs and pelvic compression belts. 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. Participants: Thirty participants with unilateral pain near the SIJ will be recruited for the study and randomly assigned to 1 of 2 treatment groups (stabilization plus belt or stabilization alone). Both groups will receive a lumbopelvic stabilization program for 12 weeks. The stabilization plus belt group will also receive a pelvic compression belt to be worn continuously for the first 4 weeks. 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. These outcomes will be assessed at baseline, 4 weeks, and 3 months post-intervention. 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. Data Analysis: Two separate ANOVAs (group x time) with repeated measures will be used to examine the effect of the interventions on disability and the percent change of muscle thickness. Whitney U-test will be used to analyze the NPRS data, and descriptive statistics will be used to report the GROC scores. Clinical Relevance: The results of the study may provide evidence in prescribing pelvic compression belt for those with SIJ pain. It will also offer guidance as to how and when pelvic compression belts should be used in this population. Finally, it will guide physical therapists in prescribing effective interventions for those with SIJ pain.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Texas Woman's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lumbopelvic stabilization exercises plus sacroiliac joint belt; 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; 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.; Device: Sacroiliac joint belt; 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.
ACTIVE_COMPARATOR: Lumbopelvic stabilization exercise; The participants will be instructed in the lumbopelvic stabilization program.	Behavioral: Lumbopelvic stabilization exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale (NPRS)	The numeric pain rating scale (NPRS) is an 11-point scale with 0 representing "no pain" and 10 representing "worst imaginable pain." This scale will be used to assess pain intensity.	Baseline, 4 weeks, 12 weeks
Percent Change of Muscle Thickness for the Transverse Abdominis (TrA)	The percent change of muscle thickness of the TrA will be assessed using ultrasound imaging. The deep abdominal muscles will be imaged in brightness mode (b-mode) using the SonoSite M-Turbo Ultrasound System. A 2-5 MHz broad spectrum curvilinear transducer will be used to obtain the images. Images were saved for offline analysis using ImageJ software. The muscle thickness for each muscle was determined by the linear distance between the upper and lower fascial lines at the midpoint of the muscle as measured by ImageJ Software. The percent change of muscle thickness was calculated using the following formula: (contracted thickness - resting thickness)/ resting thickness x 100%.	Baseline, 4 weeks, 12 weeks
Change in Global Rating of Change (GROC) Scale	The GROC scale will be used to assess the participants' overall perception of improvement since the beginning the interventions. This is a scale ranging from -7 ("a very great deal worse") to 0 ("about the same") to +7 ("a very great deal better").	4 weeks, 12 weeks
Percent Change of Muscle Thickness for Internal Oblique	The percent change of muscle thickness of the Internal Oblique will be assessed using ultrasound imaging. The deep abdominal muscles will be imaged in brightness mode (b-mode) using the SonoSite M-Turbo Ultrasound System. A 2-5 MHz broad spectrum curvilinear transducer will be used to obtain the images. Images were saved for offline analysis using ImageJ software. The muscle thickness for was determined by the linear distance between the upper and lower fascial lines at the midpoint of the muscle as measured by ImageJ Software. The percent change of muscle thickness was calculated using the following formula: (contracted thickness - resting thickness)/ resting thickness x 100%.	Baseline, 4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Collaborators: Texas Physical Therapy Association
• Investigators: Principal Investigator: Kelli J Brizzolara, MS, Texas Woman's University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (ESTIMATE): March 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Low back pain; Sacroiliac joint pain; Lumbopelvic stabilization program; Pelvic compression belt; Deep abdominal muscles
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Back Pain; Low Back Pain
• Other Study ID Numbers: 16931

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO