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Completed

NCT Number: NCT04555083

Association 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?

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

‪Afaf Tahoon‬

Dokki, Giza Governorate, 12555, Egypt

About this study

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%

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Exclusion Criteria for both groups (CAI and Control )
  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. odd's ratio of sacroiliac joint dysfunction

    Time frame: throughout the study about 1 year

    association between CAI and sacroiliac joint dysfunction

Secondary outcomes

  1. difference of pelvic torsion between CAI and control

    Time frame: throughout the study about 1 year

    pelvic torsion is pelvic asymmetry in sagittal plane

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Relationship Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2020
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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