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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05466058
Other study ID # Eslam Elsayed Ali
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2022
Est. completion date February 2023

Study information

Verified date July 2022
Source General Committee of Teaching Hospitals and Institutes, Egypt
Contact Eslam Elsayed Shohda, phd,pt
Phone 01009482231
Email dreslamelsayed@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of the study: 1) to determine validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values. Hypothesis: Sensitivity of T.F palpation will be ≥ 0.70 and Specificity of T.F palpation will be ≥ 0.70.


Description:

Trigger finger (T.F) is a disorder characterized by snapping or locking of a finger. Painful popping or clicking sound is elicited by flexion and extension of the involved digit. It is a multifactorial disease . The common mechanism of triggering is that there is a mismatch of diameter between flexors tendons and the annular pulley (retinacular sheath) of the finger. A1 pulley is the most common site of pathology; hence some authors define T.F generally as a disease of A1 pulley . Many case reports revealed that A2 or A3 pulley is a site of triggering . Others revealed that flexor retinaculum or palmar aponeurosis is the site of pathology. In some cases, after intraoperatively surgeons release A1 pulley they found still triggering and found the triggering at other site . So clinician should examine all possible sites of affection before any topical procedures application or surgery, hence our question is in T.F patients is palpation valid in detecting the site of lesion? Design and Setting: the investigator propose a case control clinical trial to enroll TF patients (cases) and non TF diabetic patients (control) to detect sensitivity specificity, positive and negative predictive values for finger palpation. The study will be conducted in physical therapy outpatient clinic and radiology department at Alahrar teaching hospital, Zagazig, Egypt. Procedures: Patients will be referred by orthopedist who knows inclusion and exclusion criteria, he will refer 31 cases (patients who agree to participate in this study). Diabetic patients without Tf (155) will by refereed from outpatient clinics (control). Physical therapist will assess patients to detect site of pathology (A1, A2, A3, A4, A5, midpalm or wrist) then patients will be refereed to radiologist who will detect site of pathology by sonography.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 186
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1 - Diabetic patients will be included to this study if they have TF (cases) as clinically evaluated and refereed by orthopedist and diabetic patients not complaining of TF(control). Exclusion Criteria: 1. patients with complete locked finger. 2. Ages below 18 y is . 3. Patients with any other hand pathology .

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
palpation - ultrasonography
Physical therapist will assess patients to detect site of pathology (A1, A2, A3, A4, A5, midpalm or wrist) then patients will be refereed to radiologist who will detect site of pathology by sonography

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eslam Elsayed Ali Shohda

Outcome

Type Measure Description Time frame Safety issue
Primary validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values 6 month - 1 year
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