Trial Outcomes & Findings for Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain (NCT NCT01559948)
NCT ID: NCT01559948
Last Updated: 2019-10-07
Results Overview
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.
COMPLETED
NA
30 participants
Baseline, 4 weeks, 12 weeks
2019-10-07
Participant Flow
This study was a single blinded, mixed-design randomized clinical trial that was conducted in Dallas, Texas from January 2012 to December 2013. Thirty participants with SIJ pain who were not seeking medical care were recruited for this study via flyers and word of mouth marketing.
Exclusion criteria were current pregnancy or pregnancy in the last six months, history of surgery to the lumbar spine, pelvis, chest, or abdomen, history of congenital lumbar or pelvic anomalies, any neurological signs in the lower extremity, systemic arthritis, and history of pelvic fracture.
Participant milestones
| Measure |
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.
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.
|
Lumbopelvic Stabilization Exercise
The participants will be instructed in a lumbopelvic stabilization program.
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.
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|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain
Baseline characteristics by cohort
| Measure |
Lumbopelvic Stabilization Exc + Belt
n=15 Participants
These participants received a lumbopelvic exercise program plus a pelvic compression belt to wear for the the first four weeks of the study.
|
Lumbopelvic Stabilization Exc
n=15 Participants
The participants received a lumbopelvic exercise program.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Pain Intensity
|
3.00 units on a scale
STANDARD_DEVIATION 1.96 • n=5 Participants
|
2.73 units on a scale
STANDARD_DEVIATION 1.34 • n=7 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 12 weeksThe 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.
Outcome measures
| Measure |
Lumbopelvic Stabilization Exercise Plus Sacroiliac Joint Belt
n=15 Participants
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.
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.
|
Lumbopelvic Stabilization Exercise
n=15 Participants
The participants will be instructed in a lumbopelvic stabilization program.
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.
|
|---|---|---|
|
Oswestry Low Back Pain Questionnaire
4 weeks
|
17.20 units on a scale
Standard Deviation 10.41
|
14.67 units on a scale
Standard Deviation 6.49
|
|
Oswestry Low Back Pain Questionnaire
Baseline
|
26.00 units on a scale
Standard Deviation 10.42
|
24.40 units on a scale
Standard Deviation 9.86
|
|
Oswestry Low Back Pain Questionnaire
12 weeks
|
14.27 units on a scale
Standard Deviation 10.08
|
10.00 units on a scale
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeksThe 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.
Outcome measures
| Measure |
Lumbopelvic Stabilization Exercise Plus Sacroiliac Joint Belt
n=15 Participants
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.
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.
|
Lumbopelvic Stabilization Exercise
n=15 Participants
The participants will be instructed in a lumbopelvic stabilization program.
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.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Baseline
|
3.00 units on a scale
Standard Deviation 1.96
|
2.73 units on a scale
Standard Deviation 1.34
|
|
Numeric Pain Rating Scale (NPRS)
4 weeks
|
1.20 units on a scale
Standard Deviation 1.70
|
1.60 units on a scale
Standard Deviation 1.88
|
|
Numeric Pain Rating Scale (NPRS)
12 weeks
|
1.07 units on a scale
Standard Deviation 1.53
|
1.07 units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeksThe 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%.
Outcome measures
| Measure |
Lumbopelvic Stabilization Exercise Plus Sacroiliac Joint Belt
n=15 Participants
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.
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.
|
Lumbopelvic Stabilization Exercise
n=15 Participants
The participants will be instructed in a lumbopelvic stabilization program.
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.
|
|---|---|---|
|
Percent Change of Muscle Thickness for the Transverse Abdominis (TrA)
Baseline
|
66.52 percentage change
Standard Deviation 21.40
|
81.00 percentage change
Standard Deviation 39.53
|
|
Percent Change of Muscle Thickness for the Transverse Abdominis (TrA)
4 weeks
|
141.93 percentage change
Standard Deviation 39.39
|
170.24 percentage change
Standard Deviation 63.95
|
|
Percent Change of Muscle Thickness for the Transverse Abdominis (TrA)
12 weeks
|
96.48 percentage change
Standard Deviation 60.44
|
77.02 percentage change
Standard Deviation 40.81
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeksThe 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").
Outcome measures
| Measure |
Lumbopelvic Stabilization Exercise Plus Sacroiliac Joint Belt
n=15 Participants
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.
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.
|
Lumbopelvic Stabilization Exercise
n=15 Participants
The participants will be instructed in a lumbopelvic stabilization program.
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 Global Rating of Change (GROC) Scale
4 weeks
|
3.13 units on a scale
Standard Deviation 2.10
|
3.13 units on a scale
Standard Deviation 2.39
|
|
Change in Global Rating of Change (GROC) Scale
12 weeks
|
4.40 units on a scale
Standard Deviation 2.29
|
4.20 units on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 12 weeksThe 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%.
Outcome measures
| Measure |
Lumbopelvic Stabilization Exercise Plus Sacroiliac Joint Belt
n=15 Participants
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.
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.
|
Lumbopelvic Stabilization Exercise
n=15 Participants
The participants will be instructed in a lumbopelvic stabilization program.
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.
|
|---|---|---|
|
Percent Change of Muscle Thickness for Internal Oblique
Baseline
|
8.23 percentage change
Standard Deviation 11.59
|
5.90 percentage change
Standard Deviation 14.49
|
|
Percent Change of Muscle Thickness for Internal Oblique
4 weeks
|
-21.58 percentage change
Standard Deviation 6.89
|
-18.68 percentage change
Standard Deviation 9.59
|
|
Percent Change of Muscle Thickness for Internal Oblique
12 weeks
|
6.37 percentage change
Standard Deviation 12.34
|
7.65 percentage change
Standard Deviation 14.55
|
Adverse Events
Lumbopelvic Stabilization Exc + Belt
Lumbopelvic Stabilization Exercise
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place