Low Back Pain, Sacroiliac Strain
Conditions
Keywords
Sacroiliac Instability, Sacroiliac Strain, Hypermobility, sacroiliac sprain, tendinopathy
Brief 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.
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.
Interventions
PROCEDUREImmediate 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.
DEVICEImmediate 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.
OTHERDelayed treatment
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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 month after initial visit (baseline BPI pain score minus one-month BPI pain score) with each group using their assigned treatment | 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. |
| 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 | 2 months after baseline visit when all groups have used both the pelvic stabilization belt and the corrective exercise for one month | 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. |
| 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.. | One month comparing the different treatments at baseline and one month later. | 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. |
| 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. | 2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month. | 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. |
Countries
Canada
Participant flow
Recruitment details
Back pain sufferers on a first visit at the doctor's office
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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:
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. In supine position 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 malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium.
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. | 21 |
| 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. | 21 |
| 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. | 20 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Immediate Corrective Exercises | Immediate Use of Pelvic Support Belt | Delayed Treatment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 19 Participants | 16 Participants | 51 Participants |
| Age, Continuous | 50.14 years STANDARD_DEVIATION 15.05 | 51.8 years STANDARD_DEVIATION 10.97 | 54.3 years STANDARD_DEVIATION 12.94 | 52.03 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) White | 18 Participants | 14 Participants | 19 Participants | 51 Participants |
| Region of Enrollment Canada | 21 participants | 21 participants | 20 participants | 62 participants |
| Sacroiliac Forward Flexion Test (SIFFT) | 1.514 cm STANDARD_DEVIATION 0.688 | 1.286 cm STANDARD_DEVIATION 0.741 | 1.281 cm STANDARD_DEVIATION 0.594 | 1.359 cm STANDARD_DEVIATION 0.676 |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 10 Participants | 39 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 0 / 21 | 6 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 20 |
Outcome results
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.
Time frame: From baseline to 1 month after each participant used their assigned treatment
Population: Participants entering the study all suffered from low back pain from sacroiliac malrotation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | 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 score on a scale |
| Immediate Use of Pelvic Support Belt | Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care | 2 score on a scale |
| Delayed Treatment | Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care | -2.4 score on a scale |
Comparison: The null hypothesis assumes that after one month, there is no difference in Oswestry low back pain and disability score improvement between the three treatment groups.p-value: 0.003Kruskal-Wallis
p-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis: there is no difference in Oswestry low back pain and disability score between those using a pelvic support belt and those using usual treatmentp-value: 0.314Wilcoxon (Mann-Whitney)
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.
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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | Oswestry Low-Back Pain Disability Questionnaire Score Change Baseline Minus 2 Month Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt | 36 score on a scale |
| Immediate Use of Pelvic Support Belt | Oswestry Low-Back Pain Disability Questionnaire Score Change Baseline Minus 2 Month Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt | 23.11 score on a scale |
Comparison: Oswestry low back pain and disability (ODI) score change over two months for all participants. This compares the score at initial visit and the score 2 months later after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. =(ODI time 0 - ODI 2 months). The greater the difference, the better the recovery of back function.p-value: <0.001Kruskal-Wallis
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.
Time frame: 2 months after baseline visit when all groups have used both the pelvic stabilization belt and the corrective exercise for one month
Population: People with low back pain and malrotated sacroiliac joints.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | 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 score on a scale |
| Immediate Use of Pelvic Support Belt | 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 | 3.5 score on a scale |
Comparison: All participants are assessed as a single group as they receive the same two treatments for one month. Brief pain inventory (BPI) score change over two months for all participants. This compares BPI score at baseline visit and BPI score 2 months later, after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. The score is between 0 and 10. The higher the change in score the greater the pain relief.p-value: <0.001Kruskal-Wallis
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.
Time frame: 1 month after initial visit (baseline BPI pain score minus one-month BPI pain score) with each group using their assigned treatment
Population: People with low back pain and malrotated sacroiliac joints.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | 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 score on a scale |
| Immediate Use of Pelvic Support Belt | 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 score on a scale |
| Delayed Treatment | 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 | 0.25 score on a scale |
Comparison: The null hypothesis assumes that after one month, there is no difference in brief pain inventory score improvement between the three treatment groups.p-value: 0.17Kruskal-Wallis
Comparison: The brief pain inventory score at the one month visit, is used to compare the pain levels of those having done one month of corrective exercises to those who continued with conventional treatments for their low back pain.p-value: 0.089Wilcoxon (Mann-Whitney)
Comparison: The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatmentp-value: 0.092Wilcoxon (Mann-Whitney)
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.
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.
Population: People with back pain and malrotated sacroiliac joints. Corona virus pandemic prevented 28 participants from returning for a final examination.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | 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 cm |
| Immediate Use of Pelvic Support Belt | 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. | 0.3 cm |
Comparison: Since all participants have received the same 2 treatment for one month, we will treat them as a single group. We will measure the distance between their posterior superior iliac spine levels (PSISL) when they enter the study and two months later after they have used the corrective exercise and the sacroiliac belt for one month. Corona prevented some participants from returning for examination, which this test requires. Only 11 participants were present in each group: 33 participants tested.p-value: <0.0001t-test, 2 sided
p-value: <0.001Kruskal-Wallis
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.
Time frame: One month comparing the different treatments at baseline and one month later.
Population: People with back pain and malrotated sacroiliac joints
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | 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 cm |
| Immediate Use of Pelvic Support Belt | 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.. | 1.125 cm |
| Delayed Treatment | 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.. | 0.25 cm |
Comparison: The null hypothesis assumes there is no improvement after one month in posterior superior iliac spine levels (PSISL) measured using the sacroiliac forward flexion test (SIFFT) between the three treatment groups.p-value: 0.016Kruskal-Wallis
Comparison: 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.p-value: 0.009Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.034Wilcoxon (Mann-Whitney)
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.
Time frame: 2 months
Population: All participants who entered the study having previously received acupuncture
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | Satisfaction Level With Acupuncture Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month | 0.97 score on a scale | Standard Deviation 0.71 |
| Immediate Use of Pelvic Support Belt | Satisfaction Level With Acupuncture Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month | 2.41 score on a scale | Standard Deviation 0.7 |
Comparison: the null hypothesis is that all participants were as satisfied with the acupuncture as they were with using the corrective exercises and the pelvic stabilization beltp-value: <0.00001t-test, 2 sided
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.
Time frame: 2 months
Population: All participants who entered the study having previously received treatment by a chiropractor
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | Satisfaction Level With Chiropractic Manipulation Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | 1 score on a scale | Standard Deviation 0.91 |
| Immediate Use of Pelvic Support Belt | Satisfaction Level With Chiropractic Manipulation Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | 2.28 score on a scale | Standard Deviation 0.83 |
Comparison: the null hypothesis is that all participants were as satisfied with treatments by a chiropractor as they were with using the corrective exercise and the pelvic stabilization beltp-value: <0.00001t-test, 2 sided
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.
Time frame: 2 months
Population: All participants who entered the study having previously performed core exercises
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | Satisfaction Level With Core Exercises Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | 1.08 score on a scale | Standard Deviation 0.78 |
| Immediate Use of Pelvic Support Belt | Satisfaction Level With Core Exercises Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | 2.21 score on a scale | Standard Deviation 0.81 |
Comparison: the null hypothesis is that all participants were as satisfied with the core exercises as they were with using the corrective exercise and the pelvic stabilization beltp-value: <0.00001t-test, 2 sided
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.
Time frame: 2 months
Population: All participants who entered the study having previously received massage therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | Satisfaction Level With Massage Therapy Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used For One Month | 1.19 score on a scale | Standard Deviation 0.86 |
| Immediate Use of Pelvic Support Belt | Satisfaction Level With Massage Therapy Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used For One Month | 2.36 score on a scale | Standard Deviation 0.73 |
Comparison: The null hypothesis is that all participants were as satisfied with massage therapy as they were with using the corrective exercise and the pelvic stabilization belt.p-value: <0.00001t-test, 2 sided
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.
Time frame: 2 months
Population: Participants in the study who had received physiotherapy treatments prior to entering the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | Satisfaction Level With Physiotherapy Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month | 1.02 score on a scale | Standard Deviation 0.89 |
| Immediate Use of Pelvic Support Belt | Satisfaction Level With Physiotherapy Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month | 2.32 score on a scale | Standard Deviation 0.81 |
Comparison: the null hypothesis is that all participants were as satisfied with the physiotherapy as they were with using the corrective exercises and the pelvic stabilization beltp-value: <0.00001t-test, 2 sided
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.
Time frame: 2 months
Population: All participants who entered the study having previously participated in yoga exercises
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Corrective Exercises (SIFFTE) | Satisfaction Level With Yoga Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | 0.92 score on a scale | Standard Deviation 0.83 |
| Immediate Use of Pelvic Support Belt | Satisfaction Level With Yoga Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month | 2.37 score on a scale | Standard Deviation 0.84 |
Comparison: The null hypothesis is that all participants were as satisfied with the yoga exercises as they were with using the corrective exercises and the pelvic stabilization beltp-value: <0.00001t-test, 2 sided