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

July 19, 2022 updated by: Eslam Elsayed Ali Shohda

Principal Investigator

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound group
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.
Device: Theraputic ultrasound
Therapeutic ultrasound
Other Names:
  • antiinflamatory drug
Active Comparator: placepo group
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.
Device: Theraputic ultrasound
Therapeutic ultrasound
Other Names:
  • antiinflamatory drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: 6 month - 1 year
measured by visual analog scale
6 month - 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
number of daily finger triggering
Time Frame: 6 month - 1 year
6 month - 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eslam Elsayed Ali Shohda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

July 17, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GeneralCTHI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

to think about important or not

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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