Pain, NeuropathicEarly Phase 1NCT05344495
Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome:
A Early Phase 1 study testing hyalase group and midazolam group in people with Pain, Neuropathic, run by Minia University at 1 site in Egypt.
Trial summary
Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pain, Neuropathic
- What is being tested?
- hyalase group and midazolam group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 1 Aug 2022
- Phase
- Early Phase 1
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months .
Who cannot join
- Diabetic patients
- Pregnant population .
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mina Raouf
ALMinya, Minya Governorate, 6115
mina raouf, 01015752424, drmina2015@gmail.com
About this study
Official title: Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.
Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy
- Conditions
- Pain, Neuropathic
- Being tested
- hyalase group, midazolam group
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyalase groupDrug
Also called Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%
bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.
midazolam groupDrug
Also called Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%
2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| hyalse group | Active comparator | ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5% Receives: Drug: hyalase group |
| midazolam group | Active comparator | ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5% Receives: Drug: midazolam group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain
Measured: 6 months
Secondary outcomes (3)
Boston questionnaire
symptom severity ... function severity
Measured: 6 months
median nerve sonogrphy
cross sectional area
Measured: 6 months
Nerve electrophysiology
sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start10 Jan 2022
- Primary completion20 Jul 2022 (estimated)
- Study completion1 Aug 2022 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
- NCT05344495
- Sponsor's protocol ID
- 277/4-2022
- Status last verified
- Jun 2022
- First submitted
- 14 Apr 2022
- Last updated
- 15 Jun 2022
- 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 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.
- ClinicalTrials.gov ID
- NCT05344495
- Acronym / sponsor ID
- 277/4-2022
- Conditions
- Pain, Neuropathic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 25 Apr 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.
Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyalse group | Active comparator | Drug: hyalase groupultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5% |
| midazolam group | Active comparator | Drug: midazolam groupultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5% |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months .
Key exclusion criteria (3 listed)
- Diabetic patients
- Pregnant population .
- 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 |
|---|---|---|
| hyalase groupAlso: Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase. | Drug | hyalse group |
| midazolam groupAlso: Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5% | Drug | midazolam group |
Primary outcome
pain score
Time frame: 6 months
visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain
3 secondary outcomes
Boston questionnaire
Time frame: 6 months
median nerve sonogrphy
Time frame: 6 months
Nerve electrophysiology
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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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 Early Phase 1 study testing hyalase group and midazolam group 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 3 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 15 Jun 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 score (time frame: 6 months). 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 15 Jun 2022.