Sacroiliac StrainSIbackpainNCT03888235
Correction of Low Back Pain From Sacroiliac Malrotation With a Simple in Home Exercise
A study testing Immediate corrective exercises, Immediate use of pelvic support belt and Delayed treatment in people with Sacroiliac Strain and Low Back Pain, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Strain, Low Back Pain
- What is being tested?
- Immediate corrective exercises, Immediate use of pelvic support belt and Delayed treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2019to 11 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Helene Bertrand Inc.
North Vancouver, British Columbia, V7M 2K2
About this study
Official title: Frequency of Sacroiliac Malrotation in Low Back Pain and Correction With a Simple In-home Exercise: A Randomized Study Comparing Those Treated Immediately to Those Waiting One Month for Treatment
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.
Read the detailed description
Potential participants with low back pain will answer a questionnaire to eliminate lumbar or hip pathology, ankylosing spondylitis or major leg length discrepancy as cause. If they state they do not have these, they will be given an appointment to be assessed to eliminate the presence of these conditions and to determine if they suffer from sacroiliac malrotation. To this effect, the sacroiliac forward flexion test (SIFFT) will be done: leaning on a counter with their body horizontal to tilt the pelvis forward and lower the sacrum and their legs vertical to push the innominate bones upwards via the hip joints, to expose the posterior superior iliac spines (PSISs). Pressure below the PSISs will be used to assess their inferior limits which will be marked and their levels assessed using a carpenter's level. The distance between the PSIS levels will be recorded. If there is tenderness under the higher PSIS, the ilium is malrotated anteriorly on the sacrum. If the area under the lower PSIS is tender, the ilium is malrotated posteriorly on the sacrum.
Participants are then randomized into three groups: group 1 is taught how to assess the direction of the malrotation, then how to perform the appropriate corrective exercise:
- With the foot of the anteriorly rotated side and the knee on the posteriorly rotated side on the floor, hands on the floor on either side of the foot, the participant leans forward hard to push his anteriorly rotated ilium posteriorly with his thigh and stretches the opposite thigh posteriorly to pull the posteriorly rotated ilium forward.
- Anterior malrotation can also be corrected by placing the foot on the malrotated side on a chair seat, flexing the other knee to touch the seat edge and pulling with both hands up on the seat while leaning back, to drive the thigh against the anterior superior iliac spine (ASIS), thus pushing it backwards.
- If unable to do these, participants can lie supine on the table, thigh on the posterior side extended. On the anterior side the knee is flexed and the foot is on the assistant's sternum as he/she leans forward, pushing the thigh against the ASIS. Downward pressure on the sartorius and rectus femoris just above the knee causes the ASIS and the anterior inferior iliac spine (AIIS) to be pulled on, rotating the ilium anteriorly.
Each position is held for 2 minutes, with up to 2 repetitions as needed. At home, the procedure is repeated as needed for pain relief.
Group 2 are given a pelvic stabilization belt and taught how to apply it: tightly around the pelvis below the anterior superior iliac spines (ASISs), to stabilize the sacroiliac joints as malrotation occurs as a result of pelvic instability. The belt is used for activities known to cause back pain.
Group 3 are instructed to continue their usual treatments and given an appointment to return one month later to receive instruction for the exercise and given the belt At 1 month all are reassessed. Group 1: use and effectiveness of the exercises is recorded and they are given the belt. Group 2: use and effectiveness of the belt is recorded and they are taught how to examine and correct their sacroiliac joints. Group 3: use and satisfaction with their current treatment is recorded. They are then taught the examination and corresponding exercise and given the belt.
At 2 months, when all participants have used both treatments for one month, all are reassessed.
Data collected includes:
at the first visit: Diagnoses associated with low back pain: lumbar spondylosis, hip arthritis, hypermobility, leg length discrepancy.
Conditions associated with sacroiliac malrotation, tendinitis of sacroiliac joint stabilizer muscles and lateral femoral cutaneous neuropathy. Muscle insertions tested include quadratus lumborum, gluteus medius and minimus, piriformis, iliopsoas, biceps femoris, semimembranosus and semitendinosus.
At all visits:
Brief pain inventory pain severity (BPI PS), the Oswestry low-back disability scores (ODI) and the distance in centimetres between the posterior superior iliac spine levels from the SIFFT test (PSISL), at intake, one month and two months visits. Together with the following:
Use of pain medications alcohol and marijuana Use and satisfaction with other treatments for back pain relief (physiotherapy, acupuncture, yoga, core exercises, chiropractor, massage).
Position of the malrotated sacroiliac joint or joints. Distance in centimetres between the levels of the PSISs before and after the corrective exercise. (Visits 2 and 3 for all, visits 1, 2, 3 for group 1) Numeric rating scale pain score after the corrective exercise. Use of and satisfaction with the SI corrective exercise at first visit for group 1 and at the second and third visit for all.
Use of and satisfaction with the pelvic belt at the first visit for group 2 and at the second and third visits for all.
- Conditions
- Sacroiliac Strain, Low Back Pain
- Being tested
- Immediate corrective exercises, Immediate use of pelvic support belt, Delayed treatment
- Keywords
- Sacroiliac Instability, Sacroiliac Strain, Hypermobility, sacroiliac sprain, tendinopathy
- Medical subject headings
- Low Back Pain, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate corrective exercisesProcedure or surgery
Also called Immediate use of sacroiliac corrective exercises
The sacroiliac forward flexion test (SIFFT) finds the position of each innominate bone. Subjects learn 1 of 3 exercises. To correct anterior rotation, flex the thigh hard against the ilium, pushing it backwards. To correct posterior rotation, hyperextend the thigh to pull the ilium forward. 1.Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. 2. Supine, anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. 3. For anterior rotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold position for 2 minutes. Use as needed for pain control. They are reassessed one month later when they receive the pelvic support belt. Both treatments used together will be assessed one month after.
Immediate use of pelvic support beltDevice
Also called Serola pelvic support belt
Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later.
At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later.
Delayed treatmentOther
Also called One month delay prior to receiving sacroiliac corrective exercises and pelvic support belt
Participants will continue the treatments they are currently using to relieve their low back pain for one month. At their one-month visit, they will be taught how to assess the direction of sacroiliac malrotation and how to do the corrective exercise. They will also be fitted for a pelvic stabilization belt.
| Study group | Role | What they receive |
|---|---|---|
| Immediate corrective exercises | Experimental | At this visit, participants will be examined as described in the protocol and given an exercise to correct their sacroiliac malrotation. They will use this exercise as needed for pain control. They will be reassessed one month later.
At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. Receives: Procedure: Immediate corrective exercises |
| Immediate use of pelvic support belt | Experimental | Participants will be given a pelvic support belt to stabilize their pelvis. They will use this belt for activities likely to precipitate back pain. They will be reassessed one month later.
At that time they will be given the exercises and the concurrent use of both treatments will be assessed at their last visit one month after that. Receives: Device: Immediate use of pelvic support belt |
| Delayed treatment | Active comparator | These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt.
The concurrent use of both treatments will be assessed at their last visit one month after that. Receives: Other: Delayed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care
Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 1 month later. This score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored X5). Minimum = 0, maximum = 100. Higher scores mean a worse outcome.
Measured: From baseline to 1 month after each participant used their assigned treatment
Oswestry Low-Back Pain Disability Questionnaire Score Change Baseline Minus 2 Month Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt
Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 2 months later after using the corrective exercise + the pelvic stabilization belt for one month. =(ODI at assessment - ODI at 2 months). The ODI score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored). Minimum = 0, maximum = 100. Higher scores mean greater disability, a worse outcome. The greater the change, the better the outcome.
Measured: Two months: from baseline visit to last visit two months later when all participants have used both the pelvic stabilization belt and the corrective exercise for one month
Secondary outcomes (4)
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
Change in BPI pain score between baseline assessment visit and visit one month later: on a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours:
- on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the one month visit means a better outcome.
Measured: 1 month after initial visit (baseline BPI pain score minus one-month BPI pain score) with each group using their assigned treatment
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
Change in BPI pain score between baseline visit and visit minus BPI pain score two months later after one month of using corrective exercise + pelvic stabilization belt On a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours: • on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the later visit means a better outcome.
Measured: 2 months after baseline visit when all groups have used both the pelvic stabilization belt and the corrective exercise for one month
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..
Difference in distance in centimetres between the levels of the higher \& the lower posterior superior iliac spines as measured using a carpenter's level between the value found on admission and that found one month later (PSISL). The minimum is 0 cm, the maximum is 3.5 cm. Higher scores mean a worse outcome. The greater difference when the distance is calculated between admission and one or two months later means a better outcome.
Measured: One month comparing the different treatments at baseline and one month later.
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.
The distance between the levels (determined using a carpenter's level) of the higher \& the lower posterior superior iliac spines (PSISL) was measured in centimetres. The outcome measure is the difference between the value found on admission and that (PSISL) value found two months later after all participants have use the corrective exercises (SIFFT E) and the sacroiliac stabilizer belt for one month. The minimum is 0 cm, the maximum is 3.5 cm. On admission, higher scores mean a worse outcome. The greater difference when the distance is calculated between admission and two months later means a better outcome.
Measured: 2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start28 Nov 2019
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac StrainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Of all the patients with low back pain, those with sacroiliac malrotation will be randomized to: group 1 an exercise to correct the malrotation, group 2 given a pelvic belt to stabilize the sacroiliac joints, group 3: use of usual treatment and treatment with the belt and exercise one month later. The degree of pain relief and improved function between the first visit and the second visit one month later will be assessed.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Bertrand, University of British Columbia
- Investigators
- Helene Bertrand, Principal investigator, University of British Columbia Department of family practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888235
- Sponsor's protocol ID
- H19-01224
- Acronym
- SIbackpain
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2019
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The encrypted de-identified database will be emailed to other researchers.
Publications
Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
PubMed 11172169Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
PubMed 17909209Szadek KM, van der Wurff P, van Tulder MW, Zuurmond WW, Perez RS. Diagnostic validity of criteria for sacroiliac joint pain: a systematic review. J Pain. 2009 Apr;10(4):354-68. doi: 10.1016/j.jpain.2008.09.014. Epub 2008 Dec 19.
PubMed 19101212Potter NA, Rothstein JM. Intertester reliability for selected clinical tests of the sacroiliac joint. Phys Ther. 1985 Nov;65(11):1671-5. doi: 10.1093/ptj/65.11.1671.
PubMed 2932746Bertrand H, Reeves KD, Mattu R, Garcia R, Mohammed M, Wiebe E, Cheng AL. Self-Treatment of Chronic Low Back Pain Based on a Rapid and Objective Sacroiliac Asymmetry Test: A Pilot Study. Cureus. 2021 Nov 11;13(11):e19483. doi: 10.7759/cureus.19483. eCollection 2021 Nov.
PubMed 34912624
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Sacroiliac Malrotation in Low Back Pain and Correction With a Simple In-home Exercise: A Randomized Study Comparing Those Treated Immediately to Those Waiting One Month for Treatment
- ClinicalTrials.gov ID
- NCT03888235
- Acronym / sponsor ID
- SIbackpain / H19-01224
- Conditions
- Sacroiliac Strain, Low Back Pain
- Keywords
- Sacroiliac Instability, Sacroiliac Strain, Hypermobility, sacroiliac sprain, tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Potential participants with low back pain will answer a questionnaire to eliminate lumbar or hip pathology, ankylosing spondylitis or major leg length discrepancy as cause. If they state they do not have these, they will be given an appointment to be assessed to eliminate the presence of these conditions and to determine if they suffer from sacroiliac malrotation. To this effect, the sacroiliac forward flexion test (SIFFT) will be done: leaning on a counter with their body horizontal to tilt the pelvis forward and lower the sacrum and their legs vertical to push the innominate bones upwards via the hip joints, to expose the posterior superior iliac spines (PSISs). Pressure below the PSISs will be used to assess their inferior limits which will be marked and their levels assessed using a carpenter's level. The distance between the PSIS levels will be recorded. If there is tenderness under the higher PSIS, the ilium is malrotated anteriorly on the sacrum. If the area under the lower PSIS is tender, the ilium is malrotated posteriorly on the sacrum.
Participants are then randomized into three groups: group 1 is taught how to assess the direction of the malrotation, then how to perform the appropriate corrective exercise:
- With the foot of the anteriorly rotated side and the knee on the posteriorly rotated side on the floor, hands on the floor on either side of the foot, the participant leans forward hard to push his anteriorly rotated ilium posteriorly with his thigh and stretches the opposite thigh posteriorly to pull the posteriorly rotated ilium forward.
- Anterior malrotation can also be corrected by placing the foot on the malrotated side on a chair seat, flexing the other knee to touch the seat edge and pulling with both hands up on the seat while leaning back, to drive the thigh against the anterior superior iliac spine (ASIS), thus pushing it backwards.
- If unable to do these, participants can lie supine on the table, thigh on the posterior side extended. On the anterior side the knee is flexed and the foot is on the assistant's sternum as he/she leans forward, pushing the thigh against the ASIS. Downward pressure on the sartorius and rectus femoris just above the knee causes the ASIS and the anterior inferior iliac spine (AIIS) to be pulled on, rotating the ilium anteriorly.
Each position is held for 2 minutes, with up to 2 repetitions as needed. At home, the procedure is repeated as needed for pain relief.
Group 2 are given a pelvic stabilization belt and taught how to apply it: tightly around the pelvis below the anterior superior iliac spines (ASISs), to stabilize the sacroiliac joints as malrotation occurs as a result of pelvic instability. The belt is used for activities known to cause back pain.
Group 3 are instructed to continue their usual treatments and given an appointment to return one month later to receive instruction for the exercise and given the belt At 1 month all are reassessed. Group 1: use and effectiveness of the exercises is recorded and they are given the belt. Group 2: use and effectiveness of the belt is recorded and they are taught how to examine and correct their sacroiliac joints. Group 3: use and satisfaction with their current treatment is recorded. They are then taught the examination and corresponding exercise and given the belt.
At 2 months, when all participants have used both treatments for one month, all are reassessed.
Data collected includes:
at the first visit: Diagnoses associated with low back pain: lumbar spondylosis, hip arthritis, hypermobility, leg length discrepancy.
Conditions associated with sacroiliac malrotation, tendinitis of sacroiliac joint stabilizer muscles and lateral femoral cutaneous neuropathy. Muscle insertions tested include quadratus lumborum, gluteus medius and minimus, piriformis, iliopsoas, biceps femoris, semimembranosus and semitendinosus.
At all visits:
Brief pain inventory pain severity (BPI PS), the Oswestry low-back disability scores (ODI) and the distance in centimetres between the posterior superior iliac spine levels from the SIFFT test (PSISL), at intake, one month and two months visits. Together with the following:
Use of pain medications alcohol and marijuana Use and satisfaction with other treatments for back pain relief (physiotherapy, acupuncture, yoga, core exercises, chiropractor, massage).
Position of the malrotated sacroiliac joint or joints. Distance in centimetres between the levels of the PSISs before and after the corrective exercise. (Visits 2 and 3 for all, visits 1, 2, 3 for group 1) Numeric rating scale pain score after the corrective exercise. Use of and satisfaction with the SI corrective exercise at first visit for group 1 and at the second and third visit for all.
Use of and satisfaction with the pelvic belt at the first visit for group 2 and at the second and third visits for all.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Of all the patients with low back pain, those with sacroiliac malrotation will be randomized to: group 1 an exercise to correct the malrotation, group 2 given a pelvic belt to stabilize the sacroiliac joints, group 3: use of usual treatment and treatment with the belt and exercise one month later. The degree of pain relief and improved function between the first visit and the second visit one month later will be assessed.
| Arm | Type | Receives |
|---|---|---|
| Immediate corrective exercises | Experimental | Procedure: Immediate corrective exercisesAt this visit, participants will be examined as described in the protocol and given an exercise to correct their sacroiliac malrotation. They will use this exercise as needed for pain control. They will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. |
| Immediate use of pelvic support belt | Experimental | Device: Immediate use of pelvic support beltParticipants will be given a pelvic support belt to stabilize their pelvis. They will use this belt for activities likely to precipitate back pain. They will be reassessed one month later. At that time they will be given the exercises and the concurrent use of both treatments will be assessed at their last visit one month after that. |
| Delayed treatment | Active comparator | Other: Delayed treatmentThese participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt. The concurrent use of both treatments will be assessed at their last visit one month after that. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate corrective exercisesAlso: Immediate use of sacroiliac corrective exercisesThe sacroiliac forward flexion test (SIFFT) finds the position of each innominate bone. Subjects learn 1 of 3 exercises. To correct anterior rotation, flex the thigh hard against the ilium, pushing it backwards. To correct posterior rotation, hyperextend the thigh to pull the ilium forward. 1.Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. 2. Supine, anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. 3. For anterior rotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold position for 2 minutes. Use as needed for pain control. They are reassessed one month later when they receive the pelvic support belt. Both treatments used together will be assessed one month after. | Procedure or surgery | Immediate corrective exercises |
| Immediate use of pelvic support beltAlso: Serola pelvic support beltParticipants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later. | Device | Immediate use of pelvic support belt |
| Delayed treatmentAlso: One month delay prior to receiving sacroiliac corrective exercises and pelvic support beltParticipants will continue the treatments they are currently using to relieve their low back pain for one month. At their one-month visit, they will be taught how to assess the direction of sacroiliac malrotation and how to do the corrective exercise. They will also be fitted for a pelvic stabilization belt. | Other | Delayed treatment |
Primary outcome
Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care
Time frame: From baseline to 1 month after each participant used their assigned treatment
Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 1 month later. This score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored X5). Minimum = 0, maximum = 100. Higher scores mean a worse outcome.
Oswestry Low-Back Pain Disability Questionnaire Score Change Baseline Minus 2 Month Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt
Time frame: Two months: from baseline visit to last visit two months later when all participants have used both the pelvic stabilization belt and the corrective exercise for one month
Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 2 months later after using the corrective exercise + the pelvic stabilization belt for one month. =(ODI at assessment - ODI at 2 months). The ODI score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored). Minimum = 0, maximum = 100. Higher scores mean greater disability, a worse outcome. The greater the change, the better the outcome.
4 secondary outcomes
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
Time frame: 1 month after initial visit (baseline BPI pain score minus one-month BPI pain score) with each group using their assigned treatment
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
Time frame: 2 months after baseline visit when all groups have used both the pelvic stabilization belt and the corrective exercise for one month
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..
Time frame: One month comparing the different treatments at baseline and one month later.
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.
Time frame: 2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11172169Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
- Background: PubMed 17909209Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
- Background: PubMed 19101212Szadek KM, van der Wurff P, van Tulder MW, Zuurmond WW, Perez RS. Diagnostic validity of criteria for sacroiliac joint pain: a systematic review. J Pain. 2009 Apr;10(4):354-68. doi: 10.1016/j.jpain.2008.09.014. Epub 2008 Dec 19.
- Results publication: PubMed 2932746Potter NA, Rothstein JM. Intertester reliability for selected clinical tests of the sacroiliac joint. Phys Ther. 1985 Nov;65(11):1671-5. doi: 10.1093/ptj/65.11.1671.
- Derived from this study: PubMed 34912624Bertrand H, Reeves KD, Mattu R, Garcia R, Mohammed M, Wiebe E, Cheng AL. Self-Treatment of Chronic Low Back Pain Based on a Rapid and Objective Sacroiliac Asymmetry Test: A Pilot Study. Cureus. 2021 Nov 11;13(11):e19483. doi: 10.7759/cureus.19483. eCollection 2021 Nov.
- Caitlin R Finley, Derek S Chan, Scott Garrison, et al. What are the most common conditions in primary care? Systematic review, Canadian Family Physician/ Le Médecin De Famille Canadien, 64, November 2018, 832 - 840Link provided by the sponsor.
- Levangie PK , Four clinical tests of sacroiliac joint dysfunction: the association of test results with innominate torsion among patients with and without low back pain. Phys Ther. 1999;79(11):1043.Link provided by the sponsor.
- Riddle DL, Freburger JK, Evaluation of the presence of sacroiliac joint region dysfunction using a combination of tests: a multicenter intertester reliability study. Phys Ther. 2002;82(8):772.Link provided by the sponsor.
- Description of sacroiliac forward flexion test (SIFFT), the three possible corrective exercises for sacroiliac malrotation, how to apply the pelvic stabilization beltLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The encrypted de-identified database will be emailed to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Bertrand principal investigator
University of British Columbia Department of family practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate corrective exercises, Immediate use of pelvic support belt and Delayed treatment in people with Sacroiliac Strain and Low Back Pain, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care (time frame: From baseline to 1 month after each participant used their assigned treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888235, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.