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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate corrective exercises | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helene Bertrand | University of British Columbia Department of family practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Helene Bertrand Inc. | North Vancouver | British Columbia | V7M 2K2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11172169 | Background | 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. | |
| 17909209 | Background | Chou 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. |
| Label | URL |
|---|---|
| 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 - 840 | View source |
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The encrypted de-identified database will be emailed to other researchers.
The data will probably be available by December 2020, depending on recruitment.
Researchers with university affiliation or previous back pain publications or specialists in physical medicine and rehabilitation, pain, neurology, neurosurgery, orthopedic surgery, orthopedic medicine, physiotherapy.
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Included were those with evidence of sacroiliac malrotation, excluded were those suffering from sciatic neuropathy, ankylosing spondylitis, hip pathology and leg length discrepancy greater than 3 cm.
Back pain sufferers on a first visit at the doctor's office
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Corrective Exercises | After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:
Hold the position for 2 minutes. They will use the exercise as needed for pain control and 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. |
| FG001 | Immediate Use of 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. |
| FG002 | Delayed Treatment | 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. Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients with low back pain and sacroiliac malrotation
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Corrective Exercises | After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:
Hold the position for 2 minutes. They will use the exercise as needed for pain control and 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Participants entering the study all suffered from low back pain from sacroiliac malrotation. | Posted | Median | Inter-Quartile Range | score on a scale | From baseline to 1 month after each participant used their assigned treatment |
|
The timeframe was two months from the time of the baseline assessment and assignment to a treatment group to 2 months later after all participants had used both the corrective exercises (SIFFTE) and the pelvic stabilization belt for one month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Corrective Exercises | After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:
Hold the position for 2 minutes. They will use the exercise as needed for pain control and 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash, skin irritation | Skin and subcutaneous tissue disorders | Low back pain | Non-systematic Assessment | The foam rubber backing of the pelvic stabilization belt directly against the skin caused irritation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helene Bertrand | University of British Columbia Department of Family Practice | 7782277776 | dr.hbertrand@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2019 | May 6, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 18, 2019 | Apr 23, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000096182 | Treatment Delay |
| ID | Term |
|---|---|
| D061665 | Time-to-Treatment |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
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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.
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|
| Immediate use of pelvic support belt | Device | 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 treatment | Other | 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. |
|
|
| 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. | 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. | 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. | 2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month. |
| 19101212 | Background | Szadek 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. |
| 2932746 | Result | Potter 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. |
| 34912624 | Derived | Bertrand 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. |
| 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. | View source |
| Description of sacroiliac forward flexion test (SIFFT), the three possible corrective exercises for sacroiliac malrotation, how to apply the pelvic stabilization belt | View source |
| BG001 | Immediate Use of 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. |
| BG002 | Delayed Treatment | 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 assessed then given both the exercise and the pelvic stabilization belt to use for one month. The concurrent use of both treatments will be assessed at their last visit two months after their initial visit. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sacroiliac Forward Flexion Test (SIFFT) | Participant stands flexed at the hips, body horizontal, legs vertical. PSISs are located by pressing down with the ulnar side of the thumbs advancing them cephalad towards the PSISs starting on either side of the inter-gluteal cleft. When the PSISs are reached, bony resistance is felt. Ask the participant on which side they feel pain i.e. where the joint is malrotated. The examiner then marks the area between his/her thumb and each PSIS. With the participant standing, a horizontal level is placed on the lowest mark and the distance between the level and the highest mark is measured in cm. | Mean | Standard Deviation | cm |
|
| OG000 | Immediate Corrective Exercises (SIFFTE) | After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises (SIFFTE) to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are:
Hold the position for 2 minutes. They will use the exercise as needed for pain control and 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. |
| OG001 | Immediate Use of 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 (SIFFTE) and the concurrent use of both treatments will be assessed at their last visit one month later. |
| OG002 | Delayed Treatment | 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 corrective exercise (SIFFTE) and the pelvic support belt. The concurrent use of both treatments, the corrective exercise (SIFFTE) and the pelvic support belt will be assessed at their last visit one month after that. |
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| Primary | 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. | All participants, Oswestry low-back pain disability questionnaire score change: baseline minus the score two months later after one month of use of corrective exercises and sacroiliac stabilization belt. | Posted | Median | Inter-Quartile Range | score on a scale | 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 |
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| 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 | 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. | People with low back pain and malrotated sacroiliac joints. | Posted | Median | Inter-Quartile Range | score on a scale | 1 month after initial visit (baseline BPI pain score minus one-month BPI pain score) with each group using their assigned treatment |
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| 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 | 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. | People with low back pain and malrotated sacroiliac joints. | Posted | Median | Inter-Quartile Range | score on a scale | 2 months after baseline visit when all groups have used both the pelvic stabilization belt and the corrective exercise for one month |
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| 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.. | 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. | People with back pain and malrotated sacroiliac joints | Posted | Median | Inter-Quartile Range | cm | One month comparing the different treatments at baseline and one month later. |
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| 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. | 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. | People with back pain and malrotated sacroiliac joints. Corona virus pandemic prevented 28 participants from returning for a final examination. | Posted | Median | Inter-Quartile Range | cm | 2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month. |
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| Post-Hoc | Satisfaction Level With Physiotherapy Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month | At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with physiotherapy?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome. | Participants in the study who had received physiotherapy treatments prior to entering the study. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Post-Hoc | Satisfaction Level With Acupuncture Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month | At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with acupuncture?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome. | All participants who entered the study having previously received acupuncture | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Post-Hoc | Satisfaction Level With Yoga Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with doing yoga?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome. | All participants who entered the study having previously participated in yoga exercises | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Post-Hoc | Satisfaction Level With Core Exercises Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with doing core exercises?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome. | All participants who entered the study having previously performed core exercises | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Post-Hoc | Satisfaction Level With Chiropractic Manipulation Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with the treatments you received from your chiropractor?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome. | All participants who entered the study having previously received treatment by a chiropractor | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Post-Hoc | Satisfaction Level With Massage Therapy Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used For One Month | At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with massage therapy?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome. | All participants who entered the study having previously received massage therapy | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Immediate Use of 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. | 0 | 21 | 0 | 21 | 6 | 21 |
| EG002 | Delayed Treatment | 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. Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Unspecified pain | Musculoskeletal and connective tissue disorders | Musculoskeletal | Non-systematic Assessment | 1 Uncomfortable at night, 1 feelings of restricted blood flow, 1 increased pain, 1 sometimes caused pain |
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Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
| D005159 |
| Health Care Facilities Workforce and Services |
| Wilcoxon (Mann-Whitney) |
| 0.089 |
Bonferroni alpha correction of p<0.0167. |
| Superiority |
| The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatment | Wilcoxon (Mann-Whitney) | 0.092 | Superiority |
The null hypothesis is that there is no difference in the distance between the posterior sacroiliac spine levels (PSISL) between those who use their usual low back pain treatments and those who are given the corrective exercises (SIFFTE) and use them as needed for one month. |
| Wilcoxon (Mann-Whitney) |
| 0.009 |
The Bonferroni alpha correction is used p<0.0167 |
| Superiority |
| The null hypothesis is that that using a pelvic support belt will not help correct sacroiliac joint asymmetry as measured using the distance between the posterior superior iliac spine levels (PSISL), baseline and one month later better than conventional treatment for low back pain. | Wilcoxon (Mann-Whitney) | 0.034 | Bonferroni correction p< 0.0167 | Superiority |
| Kruskal-Wallis | < 0.001 | Superiority |