Sacroiliac Joint Somatic Dysfunction
Conditions
Brief summary
Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.
Detailed description
Sacroiliac(SI) joint pain can lead to long-lasting severe pain and reduce physical function. It is shown to be the source of pain in 13-30% of patients with low back pain. Former surgical techniques had a high level of complications and low success rates. Newer mini-invasive surgical approaches have shown promising results in scientific studies. It is difficult to find an adequate control group for surgery as most patients already have tried conservative and alternative treatments without effect. A sham-designed study is the best alternative. This study is designed as a prospective randomized double blinded controlled mulitcenter trial. The investigators want to examine whether there is a difference in SI joint pain in patients operated with miniinvasive arthrodesis of the SI joint compared to a sham operated control group. Patients with SI joint pain are included. They will be randomized to either surgery with arthrodesis or sham surgery. Neither patient nor health personell who work with the patient after the surgery will know what has been done. The primary end point for the study is group difference in sacroiliac joint pain on the operated side after 6 months.
Interventions
PROCEDUREiFuse
ifuse will be implanted as described in section on the active comparator arm of the study.
PROCEDUREsham group
sham surgery will be performed as desrcribed in section on sham comparator.
RADIATIONfMRI study
Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.
Sponsors
Karolinska University Hospital
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blinded
Intervention model description
Randomized controlled trial comparing sacroiliac joint fusion and sham surgery. A prospective double blinded randomized controlled multicenter trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21-70 at time of screening 2. Patient with suspected SIJ pain for \>6 months or \>18 months for pregnancy induced pelvic girdle pain. 3. Diagnosis of the SI joint as the primary pain generator based on ALL of the following: A. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test) B. Patient has at least 3 of 6 physical examination maneuvers specific for SI joint pain: 1. Compression 2. Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust) 3. Palpation of the long dorsal ligament 4. Patrick's test (Faber) 5. Leg Raise (ASLR ) 6. Geanslens test C. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint (including previous documented test \<6 months ago) 4\. Baseline Oswestry Disability Index (ODI) score of at least 30% 5\. Baseline lower back pain score of at least 5 on 0-10 point NRS 6\. Patient should have tried adequate forms of conservative treatment with little or no response. 7\. Patient has signed study-specific informed consent 8\. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements. 9\. Patients with unilateral or bilateral pain can be included in the study if they clearly can differentiate between the two sides. It is the most painful side that will be included and randomized to SIJ fusion or sham surgery in the study.
Exclusion criteria
1. Severe low back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture. 2. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy 3. History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring. 4. Spine surgery during the past 12 months. 5. Previously diagnosed or suspected osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture) 6. Documented osteomalacia or other metabolic bone disease 7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible 8. Patients with prior successful fusion to the contra lateral side are exluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measure - Numeric Rating Scale operated side | 6 months | the primary endpoint is group difference in Numeric Rating Scale(NRS) pain-score on the operated side at six months postoperatively. Numeric rating scale is a pain-score scale from 0-10, where 0 is no pain and 10 is worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global NRS | baseline,3 ,6 ,12 ,24 months | Change from baseline global NRS at 3,6,12 and 24 months |
| NRS on non-operated side | baseline, 3, 6, 12, 24 months | Change from baseline in non-operated side NRS at 3,6,12 and 24 months |
| NRS leg pain | baseline, 3,6,12,24 months | Change from baseline leg pain NRS at 3,6,12,24 months |
| Baseline NRS | baseline, 3, 6, 12 and 24 months | Change from baseline Numeric Rating Scale (NRS) pain-score on the operated side at 3,6,12 and 24 months |
| Pelvic girdle questionnaire | baseline, 3, 6, 12, 24 months | Change in disability due to pelvic pain measured by Pelvic Girdle Questionnaire(PGQ) at 3,6,12,24 months |
| Quality of life (EQ-5D) | baseline, 3, 6, 12, 24 months | Change in quality of life measured by EQ-5D at 3,6,12,24 months |
| Device breakage, loosening or migration on CT of the sacroiliac joint | 12 months | Device breakage loosening or migration at 12 months judged by clinical symptoms and CT of the sacroiliac joint. |
| Oswestry disability index (ODI) | baseline, 3, 6,12, 24 months | Change in disability due to pelvic pain measured by Oswestry Disability Index(ODI) at 3,6,12,24 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3,6,12,24 months | registration of any adverse events after procedure completed |
| Work status | baseline, 3, 6,12, 24 months. | Patients will be asked to fill out standardized questionnaire on work status |
| Change in Compression test of the sacroiliac joint | baseline, 3, 6,12, 24 months | Change in compression test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint. |
| Change in Posterior Pelvic Pain Provocation (P4) test of the sacroiliac joint | baseline, 3, 6,12, 24 months | Change in Posterior Pelvic pain Provocation (P4) test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint. |
| Change in Palpation of long dorsal ligament as test of the sacroiliac joint | baseline, 3, 6,12, 24 months | Change in Palpation of long dorsal ligament as test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not along the ligament. |
| Change in Patricks (FABER) test of the sacroiliac joint | baseline, 3, 6,12, 24 months | Change in Patricks (FABER) test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint. . |
| Change in active straight leg raise test (ASLR) of the sacroiliac joint | baseline, 3, 6,12, 24 months | Change in active straight leg raise test(ASLR) of the sacroiliac joint which is an objective clinical test. Results are recorded on a grad 0 to 5, where not difficult at all = 0; minimally difficult = 1; somewhat difficult = 2; fairly difficult = 3; very difficult = 4; unable to do = 5. |
| Change in Gaenslens test | baseline, 3, 6,12, 24 months | Change in Gaenslens test which is an objective clinical tests for the sacroiliac joint. Outcome is recorded as positive or negative test dependent on whether pain is provoked or not in the sacroiliac joint. |
| 6 minute walk test to record ambulatory status | baseline, 3, 6,12, 24 months. | Patients will be tested with 6minute walk test to test ambulatory status. The test is performed by marking a distance equal to 50meters. The patient is instructed to walk back and forth between the marks as quickly and as many times as they manage in 6 minutes. The total distance walked is recorded. |
| Timed up and og test to record ambulatory status | baseline, 3, 6,12, 24 months. | Patients will be tested with Timed up and go, to test ambulatory status.Timed up and go test the time it takes the patient to get up from a Chair, walk 3 meters and back and be seated again. |
Countries
Norway, Sweden
Outcome results
None listed