CompletedNot Applicable

Motion Analysis in Sacroiliac Joint Dysfunction

Netherlands30 participantsStarted 2021-03-01

Plain-language summary

Rationale: The sacroiliac joint (SIJ) is increasingly being recognized as a potential cause of chronic low back and buttock pain. The SIJ is affected in 14-22% in patients presenting with this pain. Conservative treatment options include oral analgesic use, physical therapy, radiofrequency denervation and intraarticular steroid injections. When non-surgical treatment remains ineffective, surgical intervention is a reasonable option in the form of minimally invasive sacroiliac joint fusion (MISJF). Recent literature suggests that imbalance and sagittal sacropelvic morphology can occur in patients with SIJ dysfunction. Using motion analyses, the investigators want to evaluate full movement patterns in SIJ patients. Potentially, changes in these parameters can be observed before and after MISJF surgery. Objective: To determine spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity in patients suffering from SIJ dysfunction before and after MISJF surgery. Movement parameters will also be determined in healthy individuals to compare with patients suffering from SIJ dysfunction. Methods: This prospective cohort study will include patients enlisted for MISJF surgery because of SIJ dysfunction. Spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity will be examined before and 3 months after surgery in a professional Motion Lab. Movement parameter of healthy individuals will also be evaluated at the Motion Lab. All data will be analyzed using MATLAB software.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria for participating clients in the healthy study group: \- Healthy individuals under the age of 25, with no history of SI dysfunction or lower back related illnesses Inclusion criteria for participating clients in the healthy study group with the same demographic characteristics as the SI dysfunction patients: \- Healthy individuals between the age of 25 and 45, female sex and postpartum with no history of SI dysfunction or lower back related illnesses Inclusion criteria for the MISJF group: * The patient is suffering from SIJ dysfunction (uni- or bilateral) because of postpartum pelvic instability or because of Ehlers Danlos syndrome and is enlisted for primary MISJF surgery. * The patient is mobile enough to perform several tests at the motion lab, needed to obtain spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity. Exclusion criteria for all participating clients are: * The individual is not mobile and/or unable to perform tests at the motion lab, needed to obtain spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity. * Inadequate command of the Dutch language. * Age under 18 years.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pelvic obliquity during one leg stance will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in pelvic tilt during one leg stance will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in pelvic obliquity during sit-to-stand task will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in pelvic tilt during sit-to-stand task will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in cadence during gait will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in stride length during gait will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in step width during gait will be collected using VICON Nexus systems.

Trial details

NCT IDNCT04824534

SponsorZuyderland Medisch Centrum

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Sacroiliac Joint Dysfunction trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in pelvic obliquity during one leg stance will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in pelvic tilt during one leg stance will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in pelvic obliquity during sit-to-stand task will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in pelvic tilt during sit-to-stand task will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in cadence during gait will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in stride length during gait will be collected using VICON Nexus systems.

Timeframe: Before and 3 months after surgery

Change in step width during gait will be collected using VICON Nexus systems.