Association Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction

Sacroiliac Joint Dysfunction Clinical Trial

Official title:

Relationship Between Chronic Ankle Instability and Sacroiliac Joint Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555083
• Other study ID #: P.T.REC/012/002302
• Status: Completed
• Start date: January 3, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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?

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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 de?cits (sensory or motor de?cits)

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

Related Conditions & MeSH terms

• Joint Diseases
• Sacroiliac Joint Dysfunction

Locations

Country	Name	City	State
Egypt	?Afaf Tahoon?	Dokki	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	odd's ratio of sacroiliac joint dysfunction	association between CAI and sacroiliac joint dysfunction	throughout the study about 1 year
Secondary	difference of pelvic torsion between CAI and control	pelvic torsion is pelvic asymmetry in sagittal plane	throughout the study about 1 year
Secondary	correlation between pelvic torsion and giving way episodes	giving way episodes throughout the previous year and pelvic torsion by inclinometer	throughout the study about one year
Secondary	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	throughout the study about 1 year