Association Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction

June 7, 2021 updated by: Dalia Mohammad Mohammad Mosaad, Cairo University

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?

Study Overview

Status

Completed

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:

  1. Association between CAI and SIJD represents through odd's ratio (primary outcome)
  2. Pelvic torsion difference between CAI and control Calculated by Mann- Whitney test (secondary outcome)
  3. 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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Giza
      • Dokki, Giza, Egypt, 12555
        • ‪Afaf Tahoon‬

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  1. young active people between 18-30 years old
  2. 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
  3. Required a period of protected weight bearing and/or immobilization at least one day
  4. The patient reported a tendency to give way or repeatedly turn over during functional activity
  5. At least 2 giving way episodes during the year before the study onset and/or recurrent ankle sprain
  6. Perceived that the ankle was chronically weaker, more painful, and/or less functional than other non-injured ankle or than before first injury.
  7. Positive anterior drawer test and /or talar tilt test

Exclusion Criteria:

  • Exclusion Criteria for both groups (CAI and Control )

    1. Trunk asymmetry angle 5 - 7 degrees
    2. Leg length difference more than 0.5 cm
    3. History of autoimmune diseases, complains of ankylosing spondylitis and morning stiffness
    4. Participation in physical therapy regimen within a year before enrolling in the study
    5. Bilateral ankle sprain injury
    6. Ankle sprain within 3 months of participation
    7. If they had only midline or symmetrical pain above the level of L5 or radicular pain with neurological deficits (sensory or motor deficits)
    8. History of spinal surgery, infection, tumors, fracture of the spine, pelvis or lower extremities within 2 years before enrolling in the study.
    9. Hospitalization for severe trauma or car accident
    10. Pregnant women
    11. Any neurological and orthopedics diseases could affect the conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
odd's ratio of sacroiliac joint dysfunction
Time Frame: throughout the study about 1 year
association between CAI and sacroiliac joint dysfunction
throughout the study about 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of pelvic torsion between CAI and control
Time Frame: throughout the study about 1 year
pelvic torsion is pelvic asymmetry in sagittal plane
throughout the study about 1 year
correlation between pelvic torsion and giving way episodes
Time Frame: throughout the study about one year
giving way episodes throughout the previous year and pelvic torsion by inclinometer
throughout the study about one year
corelation between pelvic torsion and perceived sensation of instability
Time Frame: throughout the study about 1 year
pelvic torsion by inclinometer and perceived instability sensation through visual analogue scale, ranged from 0-10 with high score means worse result
throughout the study about 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dalia mossad, professor, professor at faculty of physical therapy Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (ACTUAL)

September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/002302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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