N/A
N=62
Correction of Low Back Pain From Sacroiliac Malrotation With a Simple in Home Exercise
Sacroiliac Strain · Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03888235 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care — 8; 2; -2.4 score on a scale — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immediate corrective exercises (Procedure); Immediate use of pelvic support belt (Device); Delayed treatment (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care |
8; 2; -2.4 | 0.003 sig |
| PRIMARY Oswestry Low-Back Pain Disability Questionnaire Score Change Baseline Minus 2 Month Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt |
36; 23.11 | < 0.001 sig |
| SECONDARY Brief Pain Inventory Score Change Over One Month. Baseline Score Minus 1 Month Score. Comparison: Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care |
1.25; 1; 0.25 | 0.17 |
| SECONDARY Brief Pain Inventory (BPI) Pain Score Change Over Two Months Comparison: Baseline (BPI) Pain Score Minus 2 Month (BPI) Pain Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt |
5.88; 3.5 | < 0.001 sig |
| SECONDARY Distance Between The Posterior Superior Iliac Spine Levels (PSISL) Using The Sacroiliac Forward Flexion (SIFFT) Test Comparing Corrective Exercise, Pelvic Belt, Conventional Treatment: Baseline Value Minus 1 Month Value.. |
1.375; 1.125; 0.25 | 0.016 sig |
| SECONDARY Distance Between The Posterior Superior Iliac Spine Levels (PSISL) Using The Sacroiliac Forward Flexion (SIFFT) Test, Baseline Minus One Month After Using Corrective Exercise (SIFFTE) + Pelvic Stabilization Belt. |
1.2; 0.3 | < 0.0001 sig |
Summary
60 participants with low back pain will be examined to determine the direction and extent of sacroiliac malrotation. If malrotation exists, they will be randomized to 3 treatment groups: 1 will be taught how to use their thigh to push the anterior superior iliac spine (ASIS) backwards for an anterior malrotation and their sartorius and rectus femoris to pull their ASIS and anterior inferior iliac spine (AIIS) forward for a posterior malrotation. 2: will be given a pelvic stabilization belt. 3: will return in one month. At the second visit at one month all participants will be treated with both exercise and belt. They will be reassessed at the third visit one month later: the scores for immediate and delayed treatment groups will be compared. Their response to these exercises and/or the pelvic belt will be tested at the first second and third visits, using the brief pain inventory pain, the Oswestry disability scores and the distance between the (posterior superior iliac spine) (PSIS) levels, filled out at every contact. Their satisfaction with previous treatments used will be compared to their satisfaction when using the exercise and belt.
Eligibility Criteria
Inclusion Criteria
- Age 19 to 90
- Participants present with pain in their low back (below the waist) or their buttocks.
- Able to attend all 3 study visits at the participating physician's office.
- Able to attend at least the first two visits with someone willing to assist them in assessing their back and help them with the necessary exercise if need be.
- Willing to perform the corrective exercise and or wear the sacroiliac stabilization belt at home as needed
- Their posterior superior iliac spines (PSISs) are not level on initial examination.
- The long dorsal sacroiliac ligament below at least one of the (PSISs) is tender to palpation on initial examination.
Exclusion Criteria
- Pain experienced is lumbar in origin
- Pain secondary to hip or other pathology
- PSISs are level at initial examination
- No tenderness to pressure under the PSISs
- Severe pain elsewhere in the body, making the assessment of back pain difficult.
- Presence of ankylosing spondylitis (seen on x-ray, pain worse at night, relieved by exercise, abnormal C reactive protein (CRP) or erythrocyte sedimentation rate (ESR)
- Obvious leg length discrepancy (> 1 ½ cm) when measured umbilicus to medial malleolus.
- Location of PSISs cannot be assessed accurately due to back mice or obesity.
Data sourced from ClinicalTrials.gov (NCT03888235). 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.