Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
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|ClinicalTrials.gov Identifier: NCT01559948|
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : February 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Behavioral: Lumbopelvic stabilization exercise Device: Sacroiliac joint belt||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
Experimental: Lumbopelvic stabilization exc + belt
The participants will be instructed in the same lumbopelvic stabilization program. Additionally, during the initial session, those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt.
Device: Sacroiliac joint belt
Those participants randomly assigned to the lumbopelvic stabilization plus belt group will also receive a pelvic compression belt. They will be taught how to don/doff the belt and instructed to wear the belt during all waking hours for the first 4 weeks of the study. The belt should be worn low around the pelvis just above the greater trochanter. 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 a 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 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.
- Change in Oswestry Low Back Pain Questionnaire [ Time Frame: week: 0, 4, 12 ]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 with higher scores representing greater disability.
- Change in Numeric Pain Rating Scale (NPRS) [ Time Frame: week: 0, 4, and 12 ]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 severity of pain.
- Percent change of muscle thickness for the transverse abdominis (TrA) and internal oblique (IO) [ Time Frame: week: 0, 4, and 12 ]The percent change of muscle thickness of the TrA and IO 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. The percent change of muscle thickness will be calculated using the following formula: (contracted thickness - resting thickness)/ resting thickness x 100%
- Change in Global rating of change (GROC) scale [ Time Frame: week: 4 and 12 ]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").
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559948
|United States, Texas|
|Texas Woman's University|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Kelli J Brizzolara, MS||Texas Woman's University|