Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01559948
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2012-02-03
Brief Title:
Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
Sponsor:
Texas Womans University
Organization:
Texas Womans University
Study Overview
Official Title:
A Randomized Clinical Trial of the Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 Fortins 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None