Sacroiliac Joint Somatic DysfunctionSIFSONCT03507049
Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain
A study testing iFuse and fMRI study in people with Sacroiliac Joint Somatic Dysfunction, run by Oslo University Hospital at 2 sites in 2 countries.
Trial summary
Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Sacroiliac Joint Somatic Dysfunction
- What is being tested?
- iFuse and fMRI study
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jun 2018to 25 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-70 at time of screening
- Patient with suspected SIJ pain for >6 months or >18 months for pregnancy induced pelvic girdle pain.
- Diagnosis of the SI joint as the primary pain generator based on ALL of the following:
- 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)
- Patient has at least 3 of 6 physical examination maneuvers specific for SI joint pain:
- Compression
Show all 18Show fewer
- Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust)
- Palpation of the long dorsal ligament
- Patrick's test (Faber)
- Leg Raise (ASLR )
- Geanslens test
- 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.
Who cannot join
- 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.
- Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
- 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.
- Spine surgery during the past 12 months.
- Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture)
- Documented osteomalacia or other metabolic bone disease
- Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
- Patients with prior successful fusion to the contra lateral side are exluded from the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain. A Prosepctive Double Blinded Randomized Controlled Multicenter Trial.
Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.
Read the 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.
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Being tested
- iFuse, sham group, fMRI study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuseProcedure or surgery
Also called SI Bone iFuse
ifuse will be implanted as described in section on the active comparator arm of the study.
sham groupProcedure or surgery
Also called Sham surgery
sham surgery will be performed as desrcribed in section on sham comparator.
fMRI studyRadiation
Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention Group receives operation with SI-joint arthrodesis with the iFuse implant. The patient undergoes full anesthesia. The procedure starts with an approximately 5cm long skin incision over the posterolateral aspect of the pelvis. A guide-pin is inserted over the sacroiliac joint at the desired entry-point, verified by fluoroscopy. The surgeons drills and boraches over the pin and the ifuse implant is inserted. This is repeated for a total of three implants. The wound is closed with non-resorbable suture. An injection of the SIJ with local anesthetic is performed under guidance of fluoroscopy at the time of the procedure. Receives: Procedure: iFuse |
| Sham group | Sham comparator | The sham operation will consist of the surgeon making the same skin incision as for an iFuse procedure, although nothing more, and then closing the wound.
The patients undergoing a sham operation will be under general anesthesia for a random time of 20-40minutes in order to keep the two procedures as similar as possible.
An injection of the SIJ with local anesthetic is performed under guidance of fluoroscopy at the time of the procedure. Receives: Procedure: sham group |
| Functional MRI study | Other | The Swedish patients will also undergo quantitative sensory testing at inclusion and at 6 month follow-up. At the same time they will undergo a cerebral MRI and a Functional MRI looking at activation of the CNS from pain in the sacroiliac joints induced by one leg lift. The purpose of this study is to look at contributing factors in treatment response. One hopes to map which CNS mechanisms are involved in causing the chronic pain these patients experience as well as how they respond to treatment. Receives: Radiation: fMRI study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure - Numeric Rating Scale operated side
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.
Measured: 6 months
Secondary outcomes (8)
Baseline NRS
Change from baseline Numeric Rating Scale (NRS) pain-score on the operated side at 3,6,12 and 24 months
Measured: baseline, 3, 6, 12 and 24 months
Global NRS
Change from baseline global NRS at 3,6,12 and 24 months
Measured: baseline,3 ,6 ,12 ,24 months
NRS on non-operated side
Change from baseline in non-operated side NRS at 3,6,12 and 24 months
Measured: baseline, 3, 6, 12, 24 months
NRS leg pain
Change from baseline leg pain NRS at 3,6,12,24 months
Measured: baseline, 3,6,12,24 months
Oswestry disability index (ODI)
Change in disability due to pelvic pain measured by Oswestry Disability Index(ODI) at 3,6,12,24 months
Measured: baseline, 3, 6,12, 24 months
Pelvic girdle questionnaire
Change in disability due to pelvic pain measured by Pelvic Girdle Questionnaire(PGQ) at 3,6,12,24 months
Measured: baseline, 3, 6, 12, 24 months
Quality of life (EQ-5D)
Change in quality of life measured by EQ-5D at 3,6,12,24 months
Measured: baseline, 3, 6, 12, 24 months
Device breakage, loosening or migration on CT of the sacroiliac joint
Device breakage loosening or migration at 12 months judged by clinical symptoms and CT of the sacroiliac joint.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start8 Jun 2018
- Primary completion25 May 2022
- Study completion25 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint Somatic DysfunctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing sacroiliac joint fusion and sham surgery. A prospective double blinded randomized controlled multicenter trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Thomas Johan Kibsgård, Oslo University Hospital
- Investigators
- Thomas Johan Dr Kibsgård, PhD, MD, Principal investigator, Oslo University HospitalPaul Dr Gerdhem, PhD, MD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507049
- Sponsor's protocol ID
- 2017/1892 A
- Acronym
- SIFSO
- Status last verified
- Jul 2022
- First submitted
- 6 Apr 2018
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Randers EM, Gerdhem P, Stuge B, Diarbakerli E, Nordsletten L, Rohrl SM, Kibsgard TJ. The effect of minimally invasive sacroiliac joint fusion compared to sham operation: a double-blind randomized placebo-controlled trial. EClinicalMedicine. 2024 Feb 1;68:102438. doi: 10.1016/j.eclinm.2024.102438. eCollection 2024 Feb.
PubMed 38328752
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain. A Prosepctive Double Blinded Randomized Controlled Multicenter Trial.
- ClinicalTrials.gov ID
- NCT03507049
- Acronym / sponsor ID
- SIFSO / 2017/1892 A
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2030 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial comparing sacroiliac joint fusion and sham surgery. A prospective double blinded randomized controlled multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: iFuseThe intervention Group receives operation with SI-joint arthrodesis with the iFuse implant. The patient undergoes full anesthesia. The procedure starts with an approximately 5cm long skin incision over the posterolateral aspect of the pelvis. A guide-pin is inserted over the sacroiliac joint at the desired entry-point, verified by fluoroscopy. The surgeons drills and boraches over the pin and the ifuse implant is inserted. This is repeated for a total of three implants. The wound is closed with non-resorbable suture. An injection of the SIJ with local anesthetic is performed under guidance of fluoroscopy at the time of the procedure. |
| Sham group | Sham comparator | Procedure: sham groupThe sham operation will consist of the surgeon making the same skin incision as for an iFuse procedure, although nothing more, and then closing the wound. The patients undergoing a sham operation will be under general anesthesia for a random time of 20-40minutes in order to keep the two procedures as similar as possible. An injection of the SIJ with local anesthetic is performed under guidance of fluoroscopy at the time of the procedure. |
| Functional MRI study | Other | Radiation: fMRI studyThe Swedish patients will also undergo quantitative sensory testing at inclusion and at 6 month follow-up. At the same time they will undergo a cerebral MRI and a Functional MRI looking at activation of the CNS from pain in the sacroiliac joints induced by one leg lift. The purpose of this study is to look at contributing factors in treatment response. One hopes to map which CNS mechanisms are involved in causing the chronic pain these patients experience as well as how they respond to treatment. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 21-70 at time of screening
- Patient with suspected SIJ pain for >6 months or >18 months for pregnancy induced pelvic girdle pain.
- Diagnosis of the SI joint as the primary pain generator based on ALL of the following:
- 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)
- Patient has at least 3 of 6 physical examination maneuvers specific for SI joint pain:
Key exclusion criteria (8 listed)
- 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.
- Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
- 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.
- Spine surgery during the past 12 months.
- Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFuseAlso: SI Bone iFuseifuse will be implanted as described in section on the active comparator arm of the study. | Procedure or surgery | Intervention group |
| sham groupAlso: Sham surgerysham surgery will be performed as desrcribed in section on sham comparator. | Procedure or surgery | Sham group |
| fMRI studyQuantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system. | Radiation | Functional MRI study |
Primary outcome
Primary outcome measure - Numeric Rating Scale operated side
Time frame: 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.
8 secondary outcomes
Baseline NRS
Time frame: baseline, 3, 6, 12 and 24 months
Global NRS
Time frame: baseline,3 ,6 ,12 ,24 months
NRS on non-operated side
Time frame: baseline, 3, 6, 12, 24 months
NRS leg pain
Time frame: baseline, 3,6,12,24 months
Oswestry disability index (ODI)
Time frame: baseline, 3, 6,12, 24 months
Pelvic girdle questionnaire
Time frame: baseline, 3, 6, 12, 24 months
Quality of life (EQ-5D)
Time frame: baseline, 3, 6, 12, 24 months
Device breakage, loosening or migration on CT of the sacroiliac joint
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 38328752Randers EM, Gerdhem P, Stuge B, Diarbakerli E, Nordsletten L, Rohrl SM, Kibsgard TJ. The effect of minimally invasive sacroiliac joint fusion compared to sham operation: a double-blind randomized placebo-controlled trial. EClinicalMedicine. 2024 Feb 1;68:102438. doi: 10.1016/j.eclinm.2024.102438. eCollection 2024 Feb.
Related trials for Sacroiliac Joint Somatic Dysfunction
RecruitingObservational study
Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction
Sacroiliac Joint Somatic Dysfunction, Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Johan Dr Kibsgård, PhD, MD principal investigator
Oslo University Hospital
Paul Dr Gerdhem, PhD, MD study chair
Karolinska University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iFuse and fMRI study in people with Sacroiliac Joint Somatic Dysfunction, run by Oslo University Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure - Numeric Rating Scale operated side (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.