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Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbopelvic stabilization exercise
Sacroiliac joint belt
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Sacroiliac joint pain, Lumbopelvic stabilization program, Pelvic compression belt, Deep abdominal muscles

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Woman's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbopelvic stabilization exercises plus sacroiliac joint belt

Lumbopelvic stabilization exercise

Arm Description

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.

The participants will be instructed in the lumbopelvic stabilization program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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%.
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").
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%.

Full Information

First Posted
February 3, 2012
Last Updated
September 16, 2019
Sponsor
Texas Woman's University
Collaborators
Texas Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT01559948
Brief Title
Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
Official Title
A Randomized Clinical Trial of the Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
Collaborators
Texas Physical Therapy Association

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Sacroiliac joint pain, Lumbopelvic stabilization program, Pelvic compression belt, Deep abdominal muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbopelvic stabilization exercises plus sacroiliac joint belt
Arm Type
Experimental
Arm Description
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.
Arm Title
Lumbopelvic stabilization exercise
Arm Type
Active Comparator
Arm Description
The participants will be instructed in the lumbopelvic stabilization program.
Intervention Type
Behavioral
Intervention Name(s)
Lumbopelvic stabilization exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sacroiliac joint belt
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry Low Back Pain Questionnaire
Description
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.
Time Frame
Baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Percent Change of Muscle Thickness for the Transverse Abdominis (TrA)
Description
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%.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change in Global Rating of Change (GROC) Scale
Description
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").
Time Frame
4 weeks, 12 weeks
Title
Percent Change of Muscle Thickness for Internal Oblique
Description
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%.
Time Frame
Baseline, 4 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli J Brizzolara, MS
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain

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