Sacroiliac Joint DysfunctionNCT04555083
Association Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction
An observational study of Sacroiliac Joint Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
chronic ankle instability previously approved in many studies that it may lead to more proximal adaptations and negative long term consequences. one of those studies reported, ankle instability patients has hamstring muscle shortening in comparison with non sprained subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2020to 30 Nov 2020
- Phase
- Observational
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Recruited from faculty of physical therapy through announcements for volunteering to participate in noninvasive study include patients complaining of ankle instability and others did not have any injury in their ankle before
Who may be able to join
- young active people between 18-30 years old
- CAI group has a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset
- Required a period of protected weight bearing and/or immobilization at least one day
- The patient reported a tendency to give way or repeatedly turn over during functional activity
- At least 2 giving way episodes during the year before the study onset and/or recurrent ankle sprain
- Perceived that the ankle was chronically weaker, more painful, and/or less functional than other non-injured ankle or than before first injury.
- Positive anterior drawer test and /or talar tilt test
Who cannot join
- Trunk asymmetry angle 5 - 7 degrees
- Leg length difference more than 0.5 cm
- History of autoimmune diseases, complains of ankylosing spondylitis and morning stiffness
- Participation in physical therapy regimen within a year before enrolling in the study
- Bilateral ankle sprain injury
- Ankle sprain within 3 months of participation
Show all 11Show fewer
- If they had only midline or symmetrical pain above the level of L5 or radicular pain with neurological deficits (sensory or motor deficits)
- History of spinal surgery, infection, tumors, fracture of the spine, pelvis or lower extremities within 2 years before enrolling in the study.
- Hospitalization for severe trauma or car accident
- Pregnant women
- Any neurological and orthopedics diseases could affect the conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction
chronic ankle instability previously approved in many studies that it may lead to more proximal adaptations and negative long term consequences. one of those studies reported, ankle instability patients has hamstring muscle shortening in comparison with non sprained subjects. another one concluded that gluteus maximums muscle has delayed activation and weakness in CAI patients. Both muscles (hamstring and gluteus Maximus ) contribute to sacroiliac joint stability. therefore, this study asked a novel research question, was sacroiliac joint dysfunction (SIJD) associated with CAI?
Read the detailed description
The sample size of this study had been calculated based on the primary outcome that was the association between CAI and SIJD after a pilot study done in order to detect odd's ratio. , calculation made by a program developed by the Centers for Disease Control and Prevention with the following inputting data :
Two-sided confidence interval 95%, power 80%, ratio of controls to cases 1, percent of control exposed 4.5% , odds ratio 32%. The sample size calculations required for this study was 28 participants (14 in each group).
Data distributions was checked for normality using Shapiro-Wilk test and for equality of variance using Box's test. Box and whiskers plots were used for detecting the outliers. Descriptive statistics calculated for demographic data. Intraclass correlation coefficients (ICC) and standard errors of measurement (SEM) were calculated to estimate the intratester reliability and precision of measurement for the static pelvic rotation
The outcomes of these study were:
- Association between CAI and SIJD represents through odd's ratio (primary outcome)
- Pelvic torsion difference between CAI and control Calculated by Mann- Whitney test (secondary outcome)
- Correlations between pelvic torsion with perceived ankle instability and number of giving way episodes calculated Pearson correlation coefficient(secondary outcome) Effect size analysis was calculated to determine the clinical significant difference. Statistical analysis was conducted using the statistical package for social studies (SPSS) for windows, version 24 (SPSS, Inc., Chicago, IL). The normative data presented as Mean ± standard deviation (SD) while non-normative data presented as median. Significance was set at p < 0.05 and total study power was set 80%
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- chronic ankle instability, Sacroiliac joint dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAI group | Case group is CAI group that recruit patients complain of ankle insatiability and giving way mainly | |
| control group | control group recruits participants with non injured ankle, matched with case group in gender and dominant limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
odd's ratio of sacroiliac joint dysfunction
association between CAI and sacroiliac joint dysfunction
Measured: throughout the study about 1 year
Secondary outcomes (3)
difference of pelvic torsion between CAI and control
pelvic torsion is pelvic asymmetry in sagittal plane
Measured: throughout the study about 1 year
correlation between pelvic torsion and giving way episodes
giving way episodes throughout the previous year and pelvic torsion by inclinometer
Measured: throughout the study about one year
corelation between pelvic torsion and perceived sensation of instability
pelvic torsion by inclinometer and perceived instability sensation through visual analogue scale, ranged from 0-10 with high score means worse result
Measured: throughout the study about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start3 Jan 2020
- Primary completion30 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohammad Mohammad Mosaad, Cairo University
- Investigators
- Dalia mossad, professor, Principal investigator, professor at faculty of physical therapy Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555083
- Sponsor's protocol ID
- P.T.REC/012/002302
- Status last verified
- Jun 2021
- First submitted
- 14 Sep 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT04555083
- Acronym / sponsor ID
- P.T.REC/012/002302
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- chronic ankle instability, Sacroiliac joint dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 18 Sep 2020 (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.
chronic ankle instability previously approved in many studies that it may lead to more proximal adaptations and negative long term consequences. one of those studies reported, ankle instability patients has hamstring muscle shortening in comparison with non sprained subjects. another one concluded that gluteus maximums muscle has delayed activation and weakness in CAI patients. Both muscles (hamstring and gluteus Maximus ) contribute to sacroiliac joint stability. therefore, this study asked a novel research question, was sacroiliac joint dysfunction (SIJD) associated with CAI?
Detailed description
The sample size of this study had been calculated based on the primary outcome that was the association between CAI and SIJD after a pilot study done in order to detect odd's ratio. , calculation made by a program developed by the Centers for Disease Control and Prevention with the following inputting data :
Two-sided confidence interval 95%, power 80%, ratio of controls to cases 1, percent of control exposed 4.5% , odds ratio 32%. The sample size calculations required for this study was 28 participants (14 in each group).
Data distributions was checked for normality using Shapiro-Wilk test and for equality of variance using Box's test. Box and whiskers plots were used for detecting the outliers. Descriptive statistics calculated for demographic data. Intraclass correlation coefficients (ICC) and standard errors of measurement (SEM) were calculated to estimate the intratester reliability and precision of measurement for the static pelvic rotation
The outcomes of these study were:
- Association between CAI and SIJD represents through odd's ratio (primary outcome)
- Pelvic torsion difference between CAI and control Calculated by Mann- Whitney test (secondary outcome)
- Correlations between pelvic torsion with perceived ankle instability and number of giving way episodes calculated Pearson correlation coefficient(secondary outcome) Effect size analysis was calculated to determine the clinical significant difference. Statistical analysis was conducted using the statistical package for social studies (SPSS) for windows, version 24 (SPSS, Inc., Chicago, IL). The normative data presented as Mean ± standard deviation (SD) while non-normative data presented as median. Significance was set at p < 0.05 and total study power was set 80%
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAI group | – | –Case group is CAI group that recruit patients complain of ankle insatiability and giving way mainly |
| control group | – | –control group recruits participants with non injured ankle, matched with case group in gender and dominant limb |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruited from faculty of physical therapy through announcements for volunteering to participate in noninvasive study include patients complaining of ankle instability and others did not have any injury in their ankle before
Key inclusion criteria (7 listed)
- young active people between 18-30 years old
- CAI group has a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset
- Required a period of protected weight bearing and/or immobilization at least one day
- The patient reported a tendency to give way or repeatedly turn over during functional activity
- At least 2 giving way episodes during the year before the study onset and/or recurrent ankle sprain
Key exclusion criteria (11 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
odd's ratio of sacroiliac joint dysfunction
Time frame: throughout the study about 1 year
association between CAI and sacroiliac joint dysfunction
3 secondary outcomes
difference of pelvic torsion between CAI and control
Time frame: throughout the study about 1 year
correlation between pelvic torsion and giving way episodes
Time frame: throughout the study about one year
corelation between pelvic torsion and perceived sensation of instability
Time frame: throughout the study about 1 year
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 8 Jun 2021.
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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.
Dalia mossad, professor principal investigator
professor at faculty of physical therapy Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 11 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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. 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?
odd's ratio of sacroiliac joint dysfunction (time frame: throughout the study about 1 year). 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 8 Jun 2021; AzTrials last refreshed its copy on 26 Oct 2026.