N/A
N=30
Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01559948 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Oswestry Low Back Pain Questionnaire — 26.00; 24.40; 17.20; 14.67 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lumbopelvic stabilization exercise (Behavioral); Sacroiliac joint belt (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas Woman's University
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Low Back Pain Questionnaire |
26.00; 24.40; 17.20; 14.67; 14.27; 10.00 | — |
| SECONDARY Numeric Pain Rating Scale (NPRS) |
3.00; 2.73; 1.20; 1.60; 1.07; 1.07 | — |
| SECONDARY Percent Change of Muscle Thickness for the Transverse Abdominis (TrA) |
66.52; 81.00; 141.93; 170.24; 96.48; 77.02 | — |
| SECONDARY Change in Global Rating of Change (GROC) Scale |
3.13; 3.13; 4.40; 4.20 | — |
| SECONDARY Percent Change of Muscle Thickness for Internal Oblique |
8.23; 5.90; -21.58; -18.68; 6.37; 7.65 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01559948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.