Trigger FingerNCT05467501
Effect of Therapeutic Ultrasound Versus Anti-inflammatory Drugs in the Treatment of Trigger Finger
A study testing Theraputic ultrasound in people with Trigger Finger, run by Eslam Elsayed Ali Shohda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Theraputic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1 - patients will be included to this study if they are trigger finger patients ( clinically evaluated and refereed by orthopedist).
Who cannot join
- 1 - complete locked finger. 2-Ages below 18 y. 3-Patients with any other hand pathology .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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?
- Conditions
- Trigger Finger
- Being tested
- Theraputic ultrasound
- Keywords
- Trigger Finger, Therapeutic Ultrasound
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraputic ultrasoundDevice
Also called antiinflamatory drug
Therapeutic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Theraputic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
measured by visual analog scale
Measured: 6 month - 1 year
Secondary outcomes (1)
number of daily finger triggering
Measured: 6 month - 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eslam Elsayed Ali Shohda
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Eslam Elsayed Ali Shohda, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467501
- Sponsor's protocol ID
- GeneralCTHI
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to think about important or not
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT05467501
- Acronym / sponsor ID
- GeneralCTHI
- Conditions
- Trigger Finger
- Keywords
- Trigger Finger, Therapeutic Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eslam Elsayed Ali ShohdaOther government
- Study start
- Jul 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Device: Theraputic ultrasoundTherapeutic 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. |
| placepo group | Active comparator | Device: Theraputic ultrasoundgroup 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 - patients will be included to this study if they are trigger finger patients ( clinically evaluated and refereed by orthopedist).
Key exclusion criteria (1 listed)
- 1 - complete locked finger. 2-Ages below 18 y. 3-Patients with any other hand pathology .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theraputic ultrasoundAlso: antiinflamatory drugTherapeutic ultrasound | Device | Ultrasound group, placepo group |
Primary outcome
pain intensity
Time frame: 6 month - 1 year
measured by visual analog scale
1 secondary outcome
number of daily finger triggering
Time frame: 6 month - 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided. to think about important or not
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Theraputic ultrasound in people with Trigger Finger, run by Eslam Elsayed Ali Shohda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam Elsayed Shohda, phd,pt (01009482231, dreslamelsayed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: 6 month - 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.