Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

• ClinicalTrials.gov Identifier: NCT01559948
• Recruitment Status: Completed
• First Posted: March 21, 2012
• Results First Posted: October 7, 2019
• Last Update Posted: October 7, 2019
• Sponsor: Texas Woman's University
• Collaborator: Texas Physical Therapy Association
• Information provided by (Responsible Party): Kelli Brizzolara, Texas Woman's University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Lumbopelvic stabilization exercise; Device: Sacroiliac joint belt	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of the Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
• Study Start Date: January 2012
• Actual Primary Completion Date: February 2014
• Actual Study Completion Date: February 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Oswestry Low Back Pain Questionnaire [ Time Frame: Baseline, 4 weeks, 12 weeks ]
   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.

Secondary Outcome Measures :

1. Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline, 4 weeks, 12 weeks ]
   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.
2. Percent Change of Muscle Thickness for the Transverse Abdominis (TrA) [ Time Frame: Baseline, 4 weeks, 12 weeks ]
   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%.
3. Change in Global Rating of Change (GROC) Scale [ Time Frame: 4 weeks, 12 weeks ]
   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. Percent Change of Muscle Thickness for Internal Oblique [ Time Frame: Baseline, 4 weeks, 12 weeks ]
   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%.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

Texas Woman's University

Dallas, Texas, United States, 75235

Sponsors and Collaborators

Texas Woman's University

Texas Physical Therapy Association

Investigators

• Principal Investigator: Kelli J Brizzolara, MS; Texas Woman's University

More Information

• Responsible Party: Kelli Brizzolara, Graduate student, Texas Woman's University
• ClinicalTrials.gov Identifier: NCT01559948
• Other Study ID Numbers: 16931
• First Posted: March 21, 2012
• Results First Posted: October 7, 2019
• Last Update Posted: October 7, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kelli Brizzolara, Texas Woman's University:

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

Additional relevant MeSH terms:

Arthralgia; Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases