Ultrasound Guided InjectionNCT03789526
Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus
A study testing ultrasound guidance in people with Ultrasound Guided Injection, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the management of tenosynovitis in DM patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ultrasound Guided Injection
- What is being tested?
- ultrasound guidance
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Dec 2018to 1 Feb 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Diabetes mellitus.
- Disease duration 3 years or more.
- Tenosynovitis of hand tendons with Richie tenderness grade 3.
Who cannot join
- • Patients with recent hand trauma.
- Patients with inflammatory hand arthritis.
- Previous tendon surgery.
- Previous tendon injection.
- Patients with contraindication for injection as related infection, uncontrolled DM or bleeding tendency.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the management of tenosynovitis in DM patients.
Read the detailed description
The current study will based on follow up study, conducted among patients presenting at outpatient rheumatology clinics of Al-Azhar University Hospitals, Egypt. with Diabetes mellitus duration at least 3 years and tenosynovitis of hand tendons with Richie tenderness grade 3.
All patients will randomized in two groups: Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
The affected tendons will scanned and scored for inflammation using ultrasound in all patients before the triamcinolone injection and then to be reassessed one month after the injection to determine the change in the tendons in both groups.
- Conditions
- Ultrasound Guided Injection
- Being tested
- ultrasound guidance
- Keywords
- Tenosynovitis, ultrasound, diabetes mellitus
- Medical subject headings
- Tenosynovitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guidanceProcedure or surgery
ultrasound guidance of tendon injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | * Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. Receives: Procedure: ultrasound guidance |
| Group 2 | No intervention | Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Tenosynovitis pain
changes in VAS scale for pain,
Measured: one month
change in Tenosynovitis tenderness
changes in Richie index for tenderness.
Measured: one month
changes in ultrasound images of the Tenoasynovitis.
changes in Gery scale images, and power Doppler images of the tendons
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start11 Dec 2018
- Primary completion31 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Guided InjectionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- * Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. * Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abogamal, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789526
- Sponsor's protocol ID
- REC-AFMG 2018/6
- Status last verified
- Jun 2019
- First submitted
- 24 Dec 2018
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03789526
- Acronym / sponsor ID
- REC-AFMG 2018/6
- Conditions
- Ultrasound Guided Injection
- Keywords
- Tenosynovitis, ultrasound, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Dec 2018 (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.
Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the management of tenosynovitis in DM patients.
Detailed description
The current study will based on follow up study, conducted among patients presenting at outpatient rheumatology clinics of Al-Azhar University Hospitals, Egypt. with Diabetes mellitus duration at least 3 years and tenosynovitis of hand tendons with Richie tenderness grade 3.
All patients will randomized in two groups: Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
The affected tendons will scanned and scored for inflammation using ultrasound in all patients before the triamcinolone injection and then to be reassessed one month after the injection to determine the change in the tendons in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. * Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: ultrasound guidance* Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. |
| Group 2 | No intervention | –Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- • Diabetes mellitus.
Key exclusion criteria (5 listed)
- • Patients with recent hand trauma.
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 |
|---|---|---|
| ultrasound guidanceultrasound guidance of tendon injection | Procedure or surgery | Group 1 |
Primary outcome
change in Tenosynovitis pain
Time frame: one month
changes in VAS scale for pain,
change in Tenosynovitis tenderness
Time frame: one month
changes in Richie index for tenderness.
changes in ultrasound images of the Tenoasynovitis.
Time frame: one month
changes in Gery scale images, and power Doppler images of the tendons
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guidance in people with Ultrasound Guided Injection, run by Al-Azhar University at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Tenosynovitis pain (time frame: one month). The study lists 3 primary outcomes in all. 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 11 Jun 2019.