Carpal Tunnel SyndromeNCT05725460
Ultrasound Guided Median Nerve Hydrodissection Using Dextrose
A study testing dextrose 5% median nerve hydrodissection in people with Carpal Tunnel Syndrome, run by Iraqi Board of medical specialties at 1 site in Iraq.
Trial summary
to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- dextrose 5% median nerve hydrodissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2023to 13 Sep 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- severe carpal tunnel syndrome failed medical management -
Who cannot join
- previous failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dextrose 5% in Comparison With Steroid in Median Nerve Ultrasound Guided Hydrodissection in Patients With Carpal Tunnel Syndrome
to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome
Read the detailed description
in some cases there is prohibition to use steroid with example the patient rejection to use steroid the maneuver planned median nerve hydrodissection using ultrasound and 10 mld of dextrose 5%, unleash the median nerve for the surrounding structure and short follow up planned to be 2 weeks
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- dextrose 5% median nerve hydrodissection
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dextrose 5% median nerve hydrodissectionProcedure or surgery
planned to be a good alternative to steroid hydrodissection
| Study group | Role | What they receive |
|---|---|---|
| dextrose 5% | Experimental | 10 mls of dextrose under ultrasound to separate the median nerve from adjacent structures Receives: Procedure: dextrose 5% median nerve hydrodissection |
| steroid | Active comparator | 10 mls of steroid used to separate the median nerve from adjacent structures Receives: Procedure: dextrose 5% median nerve hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief in 2 weeks follow up
difference in sensory and functional symptoms post median nerve hydrodissection using dextrose and compare this effect with steroid population arm using Boston questionnaire
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 posted13 Feb 2023
- Study start1 Feb 2023
- Primary completion23 Aug 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- 2 groups comparing the efficacy of dextrose water 5 % in median nerve hydrodissection
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iraqi Board of medical specialties
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725460
- Sponsor's protocol ID
- iraqiboard
- Status last verified
- May 2023
- First submitted
- 23 Jan 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dextrose 5% in Comparison With Steroid in Median Nerve Ultrasound Guided Hydrodissection in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05725460
- Acronym / sponsor ID
- iraqiboard
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Iraqi Board of medical specialtiesUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 13 Feb 2023 (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 compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome
Detailed description
in some cases there is prohibition to use steroid with example the patient rejection to use steroid the maneuver planned median nerve hydrodissection using ultrasound and 10 mld of dextrose 5%, unleash the median nerve for the surrounding structure and short follow up planned to be 2 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups comparing the efficacy of dextrose water 5 % in median nerve hydrodissection
| Arm | Type | Receives |
|---|---|---|
| dextrose 5% | Experimental | Procedure: dextrose 5% median nerve hydrodissection10 mls of dextrose under ultrasound to separate the median nerve from adjacent structures |
| steroid | Active comparator | Procedure: dextrose 5% median nerve hydrodissection10 mls of steroid used to separate the median nerve from adjacent structures |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe carpal tunnel syndrome failed medical management -
Key exclusion criteria (2 listed)
- previous failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus
- -
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 |
|---|---|---|
| dextrose 5% median nerve hydrodissectionplanned to be a good alternative to steroid hydrodissection | Procedure or surgery | dextrose 5%, steroid |
Primary outcome
pain relief in 2 weeks follow up
Time frame: 6 months
difference in sensory and functional symptoms post median nerve hydrodissection using dextrose and compare this effect with steroid population arm using Boston questionnaire
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 29 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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 dextrose 5% median nerve hydrodissection in people with Carpal Tunnel Syndrome, run by Iraqi Board of medical specialties at 1 site in Iraq.
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 2 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 29 Sep 2023. 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 Iraq. 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?
pain relief in 2 weeks follow up (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 29 Sep 2023.