Pain, NeuropathicNCT04781751
Ultrasonographic Insulin Versus Dexamethasone Injection With Local Anestheticss in Diabetic Patients With Mild to Moderate Median Nerve Entrapement Neuropathy .
A study testing insulin injection in people with Pain, Neuropathic, run by Minia University at 1 site in Egypt.
Trial summary
Insulin injection in carpal tunnel compared with dexamethsone in diabetic patients Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain, Neuropathic
- What is being tested?
- insulin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2021to 30 Apr 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All diabetic patients with carpal tunnel syndrome
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University
ALMinya, 6115
mina raouf, 01015752424, drmina2015@gmail.com
About this study
Insulin injection in carpal tunnel compared with dexamethsone in diabetic patients
Read the detailed description
Trial to decrease median nerve entrapement neuropathy recurrence using insulin co-injection
- Conditions
- Pain, Neuropathic
- Being tested
- insulin injection
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin injectionDrug
Carpal tunnel syndrome sonagraphic injection
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | No intervention | dexamethasone with local anesthetics injected for carpal tunnel relief |
| Insulin group | Active comparator | insulin with local anesthetics and dexamehtasone injected for carpal tunnel relief Receives: Drug: insulin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
consumption analgesics
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start28 Feb 2021
- Primary completion5 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies of the same condition, open and under way.
- More trials run by Minia 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781751
- Sponsor's protocol ID
- 212/2-2021
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Insulin Versus Dexamethasone Injection With Local Anestheticss in Diabetic Patients With Mild to Moderate Median Nerve Entrapement Neuropathy .
- ClinicalTrials.gov ID
- NCT04781751
- Acronym / sponsor ID
- 212/2-2021
- Conditions
- Pain, Neuropathic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 5 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 4 Mar 2021 (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.
Insulin injection in carpal tunnel compared with dexamethsone in diabetic patients
Detailed description
Trial to decrease median nerve entrapement neuropathy recurrence using insulin co-injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | No intervention | –dexamethasone with local anesthetics injected for carpal tunnel relief |
| Insulin group | Active comparator | Drug: insulin injectioninsulin with local anesthetics and dexamehtasone injected for carpal tunnel relief |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All diabetic patients with carpal tunnel syndrome
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| insulin injectionCarpal tunnel syndrome sonagraphic injection | Drug | Insulin group |
Primary outcome
pain relief
Time frame: 12 weeks
consumption analgesics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin injection in people with Pain, Neuropathic, run by Minia 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 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 4 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief (time frame: 12 weeks). 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 4 Mar 2021.