Clinical trial NCT03334799: Biomechanical Effects of Wearing a Sacroiliac Belt in Women
Official title: A Case-Control Pilot Study on the Biomechanical Effects of Wearing a Sacroiliac Belt in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain
Keywords: sacroiliac belt
kinematics
stability
pelvic girdle pain
sacroiliac instability
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: case control
Primary purpose: SCREENING

Brief summary: Women with pelvic girdle pain PGP) often get relief from using a sacroiliac belt. The study will explore if there are differences and in the changes of lower body movement in stability with the belt on and with the belt off. Women with PGP will be matched with women without to explore if there is a difference between these two groups. This will be looked at in standing and in walking.

Detailed description: SacroIliac (SI) joint dysfunction (also called pelvic girdle pain) has been associated with impaired load transfer across the lumbopelvic region. This can result in lower back pain as well as poor biomechanical adaptation during walking. Sacroiliac (SI) belts have typically been prescribed in order to mitigate pain and improve load transfer in individuals with SI joint dysfunction. It has been speculated that SI belts have the ability to instantaneously increase joint stability, and as a result improve load transfer and muscle activation and recruitment. However, this speculation is primarily based on anecdotal evidence; there is little biomechanical research supporting the effects of wearing an SI belt. In order to gain an improved understanding of the biomechanical effects of wearing an SI belt, the investigators propose to conduct a study with the following key objectives:

1. Determine if there are differences with respect to neuromuscular, kinematic, or pressure patterns during walking and/or standing between healthy stable individuals and individuals with SI joint dysfunction
2. Determine if wearing an SI belt affects neuromuscular, kinematic, or pressure patterns during walking and/or standing in women with sacroiliac instability

Variables measured will include:

1. Kinematics will be collected to quantify posture and joint angles
2. Kinetics will be collected to quantify ground reaction forces
3. Plantar pressure will be collected to quantify force distribution and center or pressure
4. Joint moments (Lumbar-pelvic and Hip) will be added as variables. The investigators will use inverse dynamics to calculate various joint moments during walking.

Eligibility criteria: Inclusion Criteria:

* Females
* Individuals with isolated SI joint dysfunction
* Individuals with shoe size 6, 7, 8 or 9 US

and matched controls by age (within 5 years), BMI (within one point) and parity

Exclusion Criteria:

* Pregnancy in the last year or presently pregnant
* Significant lumbar dysfunction
* Significant hip dysfunction
* Leg length discrepancy of 1 cm or more
* Women who have previously undergone prolotherapy or SI joint injections
* Women with previous lower back, hip, knee or ankle surgery
* Inability to stand for 60 sec unaided or to walk unaided.

Primary outcomes:
measure: Explore if 95% confidence ellipse area of the center of pressure or kinematic measures can distinguish women with PGP from women without PGP when a SI belt is applied
timeFrame: within 2 months of enrollment, measured at one point in time
Secondary outcomes:
measure: 95% confidence ellipse area of the center of pressure
timeFrame: within 2 months of enrollment, measured at one point in time
measure: kinematic changes of lower extremity
timeFrame: within 2 months of enrollment, measured at one point in time
Other outcomes:
Locations:
Study officials:
affiliation: Foothils Hospital Cumming School of Medicine
name: Magali Robert
role: PRINCIPAL_INVESTIGATOR
References: