Validity of Palpation in Detecting the Site of Lesion in Diabetic Trigger Finger Patients.
Primary Purpose
Trigger Finger, Validity of Palpation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
palpation - ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Trigger Finger focused on measuring trigger finger
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:
- patients with complete locked finger.
- Ages below 18 y is .
- Patients with any other hand pathology .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
cases
control
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05466058
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eslam Elsayed Ali Shohda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Validity of Palpation
Keywords
trigger finger
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
case control clinical trial
Masking
Investigator
Masking Description
radiologist will not know if the participant has trigger finger or not.
Allocation
Non-Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cases
Arm Type
Other
Arm Description
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
Arm Title
control
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
palpation - ultrasonography
Intervention Description
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
Primary Outcome Measure Information:
Title
validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values
Description
validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values
Time Frame
6 month - 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
patients with complete locked finger.
Ages below 18 y is .
Patients with any other hand pathology .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eslam Elsayed Shohda, phd,pt
Phone
01009482231
Email
dreslamelsayed@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eslam Elsayed Shohda, phd, pt
Organizational Affiliation
GOTHI
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
think about that
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Validity of Palpation in Detecting the Site of Lesion in Diabetic Trigger Finger Patients.
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