Validity of Palpation in Detecting the Site of Lesion in Diabetic Trigger Finger Patients.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trigger Finger; Validity of Palpation
• Intervention / Treatment: Diagnostic test: palpation - ultrasonography

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eslam Elsayed Shohda, PHD,PT; Phone Number: 01009482231; Email: dreslamelsayed@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cases; 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	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
Other: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eslam Elsayed Ali Shohda
• Investigators: Principal Investigator: Eslam Elsayed Shohda, phd, pt, GOTHI

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: trigger finger
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder
• Other Study ID Numbers: Eslam Elsayed Ali

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: think about that

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No