Pelvic Girdle PainNCT03334799
Biomechanical Effects of Wearing a Sacroiliac Belt in Women
A study testing sacroiliac belt in people with Pelvic Girdle Pain, run by University of Calgary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- sacroiliac belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2015to 9 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Case-Control Pilot Study on the Biomechanical Effects of Wearing a Sacroiliac Belt in Women
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.
Read the 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:
- 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
- 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:
- Kinematics will be collected to quantify posture and joint angles
- Kinetics will be collected to quantify ground reaction forces
- Plantar pressure will be collected to quantify force distribution and center or pressure
- Joint moments (Lumbar-pelvic and Hip) will be added as variables. The investigators will use inverse dynamics to calculate various joint moments during walking.
- Conditions
- Pelvic Girdle Pain
- Being tested
- sacroiliac belt
- Keywords
- sacroiliac belt, kinematics, stability, pelvic girdle pain, sacroiliac instability
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacroiliac beltDevice
Also called pelvic belt
standing and walking with the belt on and with the belt off
| Study group | Role | What they receive |
|---|---|---|
| Sacroiliac belt on and off | Other | Belt on and belt off Receives: Device: sacroiliac belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Pressure insoles will be used to quantify the 95% confidence ellipse area of the CoP determined from each of the 2 feet, during the 30 second standing trials. The sampling will be compounded at a rate of 100 Hz and provided a time-pressure series with a range from 15 to 1200 kPa. The 95% confidence ellipse area of both feet will be summed. The average of the 3 trials will be used. Kinematic data will be collected using eight high speed video cameras at a sample rate of 240 Hz. All test subjects will be equipped with a marker set consisting of 32 light reflecting markers according to Visual3D (C-Motion, Inc., Germantown, USA) marker set guidelines. All measurements will be made on the right side. Walking speed will be monitored using photo electronic cells. Identified and averaged for 10 over-ground walking trials for each participant using custom Matlab software (MathWorks Inc., Natick, MA, USA).
Measured: within 2 months of enrollment, measured at one point in time
Secondary outcomes (2)
95% confidence ellipse area of the center of pressure
Pressure insoles (Pedar, novel GmbH, Germany) will be used to quantify the 95% confidence ellipse area of the CoP determined from each of the 2 feet, during the 30 second standing trials. The sampling will be compounded at a rate of 100 Hz and provided a time-pressure series with a range from 15 to 1200 kPa. Prior to testing, the insoles will be calibrated as per the manufacture's protocol. All data will be analyzed using custom Matlab scripts. The 95% confidence ellipse area of both feet will be summed. The average of the 3 trials will be used.Gait variability will be assessed by calculating the average position of the CoP in the medial-lateral direction during walking using pedar pressure insoles. The mean and standard deviation of the average CoP position will be defined as gait variability in medial-lateral direction calculated for each subject, foot, and condition.
Measured: within 2 months of enrollment, measured at one point in time
kinematic changes of lower extremity
A force plate (Kistler Instrumente AG, Switzerland) recording at 2400 Hz will be positioned in the middle of a 15 meter walkway to measure ground reaction forces (GRF) during standing and walking. The threshold for determining heel strike wil be 20 N. Walking speed will be monitored using photo electronic cells (model TC Timing System; Brower Timing Systems, Draper, UT). Discrete kinematic and kinetic variables will be identified and averaged for 10 over-ground walking trials for each participant using custom Matlab software (MathWorks Inc., Natick, MA, USA).
Kinematic data will be collected using eight high speed video cameras (Motion Analysis Corporation, Santa Rosa, USA) Version 3.6.1.1315 at a sample rate of 240 Hz. All test subjects will be equipped with a marker set consisting of 32 light reflecting markers according to Visual3D (C-Motion, Inc., Germantown, USA) marker set guidelines. All measurements will be made on the right side.
Measured: within 2 months of enrollment, measured at one point in time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start25 Feb 2015
- Primary completion29 May 2015
- Study completion9 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case control
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali Robert, Principal investigator, Foothils Hospital Cumming School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334799
- Sponsor's protocol ID
- 14-2323
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be stored in repository for access by request
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Pilot Study on the Biomechanical Effects of Wearing a Sacroiliac Belt in Women
- ClinicalTrials.gov ID
- NCT03334799
- Acronym / sponsor ID
- 14-2323
- Conditions
- Pelvic Girdle Pain
- Keywords
- sacroiliac belt, kinematics, stability, pelvic girdle pain, sacroiliac instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 25 Feb 2015 (actual)
- Primary completion
- 29 May 2015 (actual)
- Study completion
- 9 Sep 2017 (actual)
- First posted
- 7 Nov 2017 (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.
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:
- 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
- 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:
- Kinematics will be collected to quantify posture and joint angles
- Kinetics will be collected to quantify ground reaction forces
- Plantar pressure will be collected to quantify force distribution and center or pressure
- Joint moments (Lumbar-pelvic and Hip) will be added as variables. The investigators will use inverse dynamics to calculate various joint moments during walking.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case control
| Arm | Type | Receives |
|---|---|---|
| Sacroiliac belt on and off | Other | Device: sacroiliac beltBelt on and belt off |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| sacroiliac beltAlso: pelvic beltstanding and walking with the belt on and with the belt off | Device | Sacroiliac belt on and off |
Primary outcome
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
Time frame: within 2 months of enrollment, measured at one point in time
Pressure insoles will be used to quantify the 95% confidence ellipse area of the CoP determined from each of the 2 feet, during the 30 second standing trials. The sampling will be compounded at a rate of 100 Hz and provided a time-pressure series with a range from 15 to 1200 kPa. The 95% confidence ellipse area of both feet will be summed. The average of the 3 trials will be used. Kinematic data will be collected using eight high speed video cameras at a sample rate of 240 Hz. All test subjects will be equipped with a marker set consisting of 32 light reflecting markers according to Visual3D (C-Motion, Inc., Germantown, USA) marker set guidelines. All measurements will be made on the right side. Walking speed will be monitored using photo electronic cells. Identified and averaged for 10 over-ground walking trials for each participant using custom Matlab software (MathWorks Inc., Natick, MA, USA).
2 secondary outcomes
95% confidence ellipse area of the center of pressure
Time frame: within 2 months of enrollment, measured at one point in time
kinematic changes of lower extremity
Time frame: within 2 months of enrollment, measured at one point in time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Undecided. Data will be stored in repository for access by request
Related trials for Pelvic Girdle Pain
Active, not recruiting
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Postpartum Pelvic Girdle Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Recruiting
Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery
Cesarean Birth, Massage
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Effects of MET With and Without Lumbopelvic Manipulation
Anterior Pelvic Tilt
Active, not recruiting
Osteopathy in Postpartum Lumbopelvic Pain
Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle 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.
Magali Robert principal investigator
Foothils Hospital Cumming School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing sacroiliac belt in people with Pelvic Girdle Pain, run by University of Calgary.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: within 2 months of enrollment, measured at one point in time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2017.