Clinical trial NCT05466058: Validity of Palpation in Detecting the Site of Lesion in Diabetic Trigger Finger Patients.
Official title: Validity of Palpation in Detecting the Site of Lesion in Diabetic Trigger Finger Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigger Finger
Validity of Palpation
Keywords: trigger finger
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2022-07-20
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case control clinical trial
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values
timeFrame: 6 month - 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GOTHI
name: Eslam Elsayed Shohda, phd, pt
role: PRINCIPAL_INVESTIGATOR
References: