Correction of Low Back Pain From Sacroiliac Malrotation With a Simple in Home Exercise

NCT03888235 | Completed Results

• 1 other identifier: H19-01224
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Strain; Low Back Pain

Keywords

Sacroiliac Instability; Sacroiliac Strain; Hypermobility; sacroiliac sprain; tendinopathy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Brief Pain Inventory Score Change Over One Month. Baseline Score Minus 1 Month Score. Comparison: Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care

  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

  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..

  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.

  2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month.

Study Arms (3)

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.

Procedure: Immediate corrective exercises

Immediate use of pelvic support belt

EXPERIMENTAL

Participants will be given a pelvic support belt to stabilize their pelvis. They will use this belt for activities likely to precipitate back pain. They will be reassessed one month later. At that time they will be given the exercises and the concurrent use of both treatments will be assessed at their last visit one month after that.

Device: Immediate use of pelvic support belt

Delayed treatment

ACTIVE COMPARATOR

These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt. The concurrent use of both treatments will be assessed at their last visit one month after that.

Other: Delayed treatment

Interventions

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.

Also known as: Immediate use of sacroiliac corrective exercises

Immediate corrective exercises

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.

Also known as: Serola pelvic support belt

Immediate use of pelvic support belt

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.

Also known as: One month delay prior to receiving sacroiliac corrective exercises and pelvic support belt

Delayed treatment

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Dr. Helene Bertrand Inc.

North Vancouver, British Columbia, V7M 2K2, Canada

Location

Related Publications (5)

• 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.

  PMID: 11172169 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.

  PMID: 17909209 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.

  PMID: 19101212 BACKGROUND

• 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.

  PMID: 2932746 RESULT

• 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.

  PMID: 34912624 DERIVED

Related Links

• 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
• Levangie PK , Four clinical tests of sacroiliac joint dysfunction: the association of test results with innominate torsion among patients with and without low back pain. Phys Ther. 1999;79(11):1043.
• 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.
• Description of sacroiliac forward flexion test (SIFFT), the three possible corrective exercises for sacroiliac malrotation, how to apply the pelvic stabilization belt

MeSH Terms

Conditions

Low Back Pain; Tendinopathy

Interventions

Treatment Delay

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Time-to-Treatment; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Helene Bertrand
• Organization: University of British Columbia Department of Family Practice

dr.hbertrand@gmail.com

7782277776

Study Officials

• Helene Bertrand

  University of British Columbia Department of family practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 25, 2019
• Study Start: November 28, 2019
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: March 26, 2025
• Results First Posted: January 29, 2021

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will probably be available by December 2020, depending on recruitment.
• Access Criteria: Researchers with university affiliation or previous back pain publications or specialists in physical medicine and rehabilitation, pain, neurology, neurosurgery, orthopedic surgery, orthopedic medicine, physiotherapy.

Locations

CA (1)