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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
Eslam Elsayed Ali Shohda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Trigger Finger focused on measuring trigger finger

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 .

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

    First Posted
    July 17, 2022
    Last Updated
    July 19, 2022
    Sponsor
    Eslam Elsayed Ali Shohda
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    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

    Learn more about this trial

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

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