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

Sponsor
Eslam Elsayed Ali Shohda (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05466058
Collaborator
(none)
186
2
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: palpation - ultrasonography
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
186 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
case control clinical trialcase control clinical trial
Masking:
Single (Investigator)
Masking Description:
radiologist will not know if the participant has trigger finger or not.
Primary Purpose:
Diagnostic
Official Title:
Validity of Palpation in Detecting the Site of Lesion in Diabetic Trigger Finger Patients.
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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]

    validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Eslam Elsayed Ali Shohda

Investigators

  • Principal Investigator: Eslam Elsayed Shohda, phd, pt, GOTHI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eslam Elsayed Ali Shohda, Dr - teaching fellow, General Committee of Teaching Hospitals and Institutes, Egypt
ClinicalTrials.gov Identifier:
NCT05466058
Other Study ID Numbers:
  • Eslam Elsayed Ali
First Posted:
Jul 20, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eslam Elsayed Ali Shohda, Dr - teaching fellow, General Committee of Teaching Hospitals and Institutes, Egypt
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022