NCT05467501

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 17, 2022

Last Update Submit

July 19, 2022

Conditions

Trigger Finger

Keywords

Trigger FingerTherapeutic Ultrasound

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    measured by visual analog scale

    6 month - 1 year

Secondary Outcomes (1)

  • number of daily finger triggering

    6 month - 1 year

Study Arms (2)

Ultrasound group

EXPERIMENTAL

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

placepo group

ACTIVE COMPARATOR

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

Interventions

Theraputic ultrasoundDEVICE

Therapeutic ultrasound

Also known as: antiinflamatory drug
Ultrasound groupplacepo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Central Study Contacts

Eslam Elsayed Shohda, phd,pt

CONTACT

01009482231dreslamelsayed@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will not know the actual ultrasound application
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 20, 2022

Study Start

July 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07