View Clinical Trial (Medical Research Study)
A Randomized Clinical Trial of the Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
| City: |
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75235 |
| Conditions: |
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Low Back Pain |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01559948 |
| Primary Contact: |
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Principal Investigator
Kelli J Brizzolara, MS
Texas Woman's University
Kelli J Brizzolara, MS
Phone: 214-689-7722
Email: kbrizzolara@twu.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas, Texas 75235
United States
Kelli J Brizzolara, PT
Phone: 214-689-7722
Email: kbrizzolara@twu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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