search
Back to results

Effect of Therapeutic Ultrasound Versus Anti-inflammatory Drugs in the Treatment of Trigger Finger

Primary Purpose

Trigger Finger

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Theraputic ultrasound
Sponsored by
Eslam Elsayed Ali Shohda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring Trigger Finger, Therapeutic Ultrasound

Eligibility Criteria

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

Inclusion Criteria:

1 - patients will be included to this study if they are trigger finger patients ( clinically evaluated and refereed by orthopedist).

Exclusion Criteria:

1 - complete locked finger. 2-Ages below 18 y. 3-Patients with any other hand pathology .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ultrasound group

    placepo group

    Arm Description

    Therapeutic ultrasound application. US parameters are 0.8 W/cm for intensity, 3 MHz for frequency and 5 min application. The device that will be used is medserve, England (the head of the device is 5cm). The physical therapy will by 6 sessions (every day). PT sessions will be done by the same physical therapist.

    group B will have a non-steroidal anti-inflammatory drug as prescribed by the same orthopedist and 2 session of massage with the head of ultrasound.

    Outcomes

    Primary Outcome Measures

    pain intensity
    measured by visual analog scale

    Secondary Outcome Measures

    number of daily finger triggering

    Full Information

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

    1. Study Identification

    Unique Protocol Identification Number
    NCT05467501
    Brief Title
    Effect of Therapeutic Ultrasound Versus Anti-inflammatory Drugs in the Treatment of Trigger Finger
    Official Title
    Principal Investigator
    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
    to determine the effect of US on pain intensity in TF patients 2) to determine the effect of US on number of daily finger triggering in TF patients.
    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. Some studies found inflammatory cells as a part of the pathology, hence anti-inflammatory drugs are the first line of treatment . Therapeutic ultrasound (US) is a form of acoustic energy which is often used in physical therapy. When US enters the body, it can affect the cells and tissues through thermal and non-thermal mechanisms. While a thermal mechanism has a direct heating effect which promotes anti-inflammatory response with increase blood flow, evidence indicates, however, that non thermal mechanisms are thought to play a primary role in producing a therapeutically significant biological effect (i.e. the stimulation of tissue regeneration) . So my question is in T.F patients does therapeutic ultrasound decrease pain more than anti-inflammatory drugs?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trigger Finger
    Keywords
    Trigger Finger, Therapeutic Ultrasound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    RCT
    Masking
    Participant
    Masking Description
    Patients will not know the actual ultrasound application
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound group
    Arm Type
    Experimental
    Arm Description
    Therapeutic ultrasound application. US parameters are 0.8 W/cm for intensity, 3 MHz for frequency and 5 min application. The device that will be used is medserve, England (the head of the device is 5cm). The physical therapy will by 6 sessions (every day). PT sessions will be done by the same physical therapist.
    Arm Title
    placepo group
    Arm Type
    Active Comparator
    Arm Description
    group B will have a non-steroidal anti-inflammatory drug as prescribed by the same orthopedist and 2 session of massage with the head of ultrasound.
    Intervention Type
    Device
    Intervention Name(s)
    Theraputic ultrasound
    Other Intervention Name(s)
    antiinflamatory drug
    Intervention Description
    Therapeutic ultrasound
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    measured by visual analog scale
    Time Frame
    6 month - 1 year
    Secondary Outcome Measure Information:
    Title
    number of daily finger triggering
    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 - patients will be included to this study if they are trigger finger patients ( clinically evaluated and refereed by orthopedist). Exclusion Criteria: 1 - complete locked finger. 2-Ages below 18 y. 3-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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    to think about important or not

    Learn more about this trial

    Effect of Therapeutic Ultrasound Versus Anti-inflammatory Drugs in the Treatment of Trigger Finger

    We'll reach out to this number within 24 hrs