Carpal Tunnel SyndromePhase 1NCT03180125
Hyaluronic Acid Hydro-dissection Use in Idiopathic Carpal Tunnel Syndrome Guided by Ultrasonic Study
A Phase 1 study testing Sodium Hyaluronate, ultrasound and Sodium Hyaluronate and 1% lidocain in people with Carpal Tunnel Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Sodium Hyaluronate, ultrasound and Sodium Hyaluronate and 1% lidocain
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2017to 15 Mar 2019
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with mild or moderate carpal tunnel diagnosed by nerve conduction study
Who cannot join
- secondary carpal tunnel to any other disease and peripheral neuropathy patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided
carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT.
Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns, It would be interesting if low molecular weight sodium hyaluorinate injection is used as an alternative conservative treatment of CTS. This study aims to investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone acetonide, under ultrasound guidance.
Read the detailed description
60 CT patients, blindly divided into two groups. Both will underwent median nerve hydro-dissection using 1% lidocain followed by group I injection of Sodium hyaluronate and group II injection of 40 mg of triamcinolone acetonide, under ultrasound guidance. Baseline VAS pain and nerve conduction study, patient satisfaction, and therapeutic duration, will be determined in 2nd week, 3rd and 6th month after the procedure. US measurements of the median nerve cross-sectional area (CSA) in the CT inlet will be compared pre and post procedure in 6th month and use NCS results as the gold standard diagnostic test.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Sodium Hyaluronate, ultrasound, Sodium Hyaluronate and 1% lidocain, Corticosteroid and 1%lidocain
- Keywords
- hydrodissection, sodium hyaluorinate
- 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.
Sodium HyaluronateDrug
Also called hyalgan
median nerve in CTS hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate guided by ultrasound
ultrasoundDevice
ultrasound guided injection
Sodium Hyaluronate and 1% lidocainDrug
injection in the carpal tunnel
Corticosteroid and 1%lidocainDrug
injection in the carpal tunnel
| Study group | Role | What they receive |
|---|---|---|
| sodium hyaluorinate ultrasound guided | Experimental | median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided Receives: Drug: Sodium Hyaluronate; Device: ultrasound; Drug: Sodium Hyaluronate and 1% lidocain |
| corticosteroid with ultrasound guided | Placebo comparator | median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided Receives: Device: ultrasound; Drug: Sodium Hyaluronate and 1% lidocain; Drug: Corticosteroid and 1%lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropathic pain VAS
0-10 VAS scale in the 2nd week after injection
Measured: 2 weeks
Secondary outcomes (1)
nerve conduction study
motor nerve conduction
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start15 Aug 2017
- Primary completion1 Oct 2017
- Study completion15 Mar 2019
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.
- More trials run by Assiut 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180125
- Sponsor's protocol ID
- Hyaluronic injection
- Status last verified
- Mar 2019
- First submitted
- 11 Jul 2016
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided
- ClinicalTrials.gov ID
- NCT03180125
- Acronym / sponsor ID
- Hyaluronic injection
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- hydrodissection, sodium hyaluorinate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 8 Jun 2017 (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.
carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT.
Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns, It would be interesting if low molecular weight sodium hyaluorinate injection is used as an alternative conservative treatment of CTS. This study aims to investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone acetonide, under ultrasound guidance.
Detailed description
60 CT patients, blindly divided into two groups. Both will underwent median nerve hydro-dissection using 1% lidocain followed by group I injection of Sodium hyaluronate and group II injection of 40 mg of triamcinolone acetonide, under ultrasound guidance. Baseline VAS pain and nerve conduction study, patient satisfaction, and therapeutic duration, will be determined in 2nd week, 3rd and 6th month after the procedure. US measurements of the median nerve cross-sectional area (CSA) in the CT inlet will be compared pre and post procedure in 6th month and use NCS results as the gold standard diagnostic test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium hyaluorinate ultrasound guided | Experimental | Drug: Sodium Hyaluronate, Device: ultrasound, Drug: Sodium Hyaluronate and 1% lidocainmedian nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided |
| corticosteroid with ultrasound guided | Placebo comparator | Device: ultrasound, Drug: Sodium Hyaluronate and 1% lidocain, Drug: Corticosteroid and 1%lidocainmedian nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with mild or moderate carpal tunnel diagnosed by nerve conduction study
Key exclusion criteria (1 listed)
- secondary carpal tunnel to any other disease and peripheral neuropathy patients
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 |
|---|---|---|
| Sodium HyaluronateAlso: hyalganmedian nerve in CTS hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate guided by ultrasound | Drug | sodium hyaluorinate ultrasound guided |
| ultrasoundultrasound guided injection | Device | corticosteroid with ultrasound guided, sodium hyaluorinate ultrasound guided |
| Sodium Hyaluronate and 1% lidocaininjection in the carpal tunnel | Drug | corticosteroid with ultrasound guided, sodium hyaluorinate ultrasound guided |
| Corticosteroid and 1%lidocaininjection in the carpal tunnel | Drug | corticosteroid with ultrasound guided |
Primary outcome
neuropathic pain VAS
Time frame: 2 weeks
0-10 VAS scale in the 2nd week after injection
1 secondary outcome
nerve conduction study
Time frame: 1 month
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 19 Mar 2019.
- Individual participant dataSharing planned: Yes
Related trials for Carpal Tunnel Syndrome
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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 Phase 1 study testing Sodium Hyaluronate, ultrasound and Sodium Hyaluronate and 1% lidocain in people with Carpal Tunnel Syndrome, run by Assiut 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: finished, as of the sponsor's last update on 19 Mar 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
neuropathic pain VAS (time frame: 2 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 19 Mar 2019.