Frequency of Sacroiliac Malrotation in Low Back Pain and Correction With a Simple In-home Exercise: A Randomized Study Comparing Those Treated Immediately to Those Waiting One Month for Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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.)
- 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)
- 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.)
研究者
Helene Bertrand
Principal Investigator
University of British Columbia