Carpal Tunnel Syndrome (CTS)Phase 4NCT07283874
Does it Matter the Volume of Injectate on the Outcome of Ultrasound-guided Perineural Injection for Carpal Tunnel Syndrome
A Phase 4 study testing Dextrose 5%, Triamcinolone Acetonide (Aristocort® C) and Lidocaine 2 % in people with Carpal Tunnel Syndrome (CTS), run by Assiut University.
Trial summary
Carpal tunnel syndrome (CTS) is an entrapment neuropathy affecting the median nerve with a lifetime prevalence of about 8% in the adult population. Carpal tunnel syndrome (CTS) occurs with the symptoms of intermittent nocturnal paresthesia and dysesthesia, followed by loss of sensation, weakness, and thenar muscle… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Dextrose 5%, Triamcinolone Acetonide (Aristocort® C) and Lidocaine 2 %
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 20-80 years old 2. Patients diagnosed with idiopathic CTS. 3. Abnormal electrophysiological analysis showing mild to moderate CTS 4. Symptoms and signs including:
- pain or paraesthesia in the median nerve innervated area (at least two digits with such symptoms between the thumb and the 4th digit) for more than 6 months not responding to conservative management including (vitamin B complex, nonsteroidal anti-inflammatory drugs, oral steroids, and/or night splint)
- positive Phalen test, Tinel sign, or flick sign
- The patient's initial examination was based on the American Academy of Orthopaedic Surgeons Clinical Practice Guideline recommendations prior to their inclusion and confirmed by nerve conduction studies
Who cannot join
- 1- Age less than 20 years 2- severe CTS (abductor policies brevis muscle atrophy with distal latency time >6.5 MS).
- 3- MN electrophysiology study revealing absent potentials. 4- its cross-sectional area (CSA) >15 mm2 by sonographic checkup. 5- previous surgery of carpal tunnel. 6- previous wrist injection within 3 months 7- history of peripheral nerve injuries (brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome) 8- CTS due to systemic causes, for example, endocrinal and/or pregnancy, rheumatoid arthritis, gouty or psoriatic osteoarthritis.
- 9- concurrent use of antihistaminic, or cortisone. 10- Participant refusal. 11- local infection. presence of coagulopathy, and/or allergy to the included medications were also points for patients' exclusion from the study
About this study
Carpal tunnel syndrome (CTS) is an entrapment neuropathy affecting the median nerve with a lifetime prevalence of about 8% in the adult population. Carpal tunnel syndrome (CTS) occurs with the symptoms of intermittent nocturnal paresthesia and dysesthesia, followed by loss of sensation, weakness, and thenar muscle atrophy in later stages.
Although the etiology of CTS is multifactorial, compression of the median nerve in a space-limited osteofibrous canal at wrist level was proposed.
Read more
The gold standard of diagnosis is electrophysiological study, but ultrasonography was applied in recent decades for a better approach to the morphology change of the median nerve.Nerve hydrodissection (HD) is a widely used technique that involves the injection of fluid to separate the nerve from the surrounding structures.
HD is now considered a novel approach for the treatment of CTS with safe and outstanding long-term effects. A potential benefit of HD is to release the pressure on the "free nerves supplying the main nerves," called "nervi nervorum." Early, the compression of the vasa nervorum would affect venous outflow, causing the accumulation of toxins in the affected part. Then, the lymphatic drainage, located outside the epineurium, would undergo compressive effects.
HD can also decrease the gliding resistance of the median nerve within the carpal tunnel, which is considered a principal patho-mechanical cause of nerve injury.
Hydrodissection HD of the entrapped median nerve is considered a safe and efficacious approach for treatment of mild to moderate CTS and could be offered to patients with severe CTS if surgery is refused or can't be done due to other medical comorbidities. The use of US-guided HD could improve symptom severity, functional status, and the US parameters of nerve entrapment. HD has a long-term efficacy outcome; 88.6% of patients reported an effective outcome, and this may vary according to the initial severity status.
Different types of injectants are available and studied, with no clear indication of use for each type. However, PRP, D5W, and HA were more efficient than NS as regards subjective and objective improvement. PRP and HA were more effective for long-term nerve recovery, while HA was preferred for the earliest response. So, we recommend making the choice based on every patient's severity scale and electrophysiological scales, which means that for patients with mild forms and severe pain.
Injection of a large volume could be a better option in order to dissect a larger area, provide a better environment for the nerve repair mechanisms, and release the vascular and neural compressive elements.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Dextrose 5%, Triamcinolone Acetonide (Aristocort® C), Lidocaine 2 %
- 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%Drug
patients injected with 8ml dextrose 5%
Dextrose 5%Drug
patients injected with 3 ml dextrose 5%
Triamcinolone Acetonide (Aristocort® C)Drug
patients injected with 1 ml Triamcinolone acetonide
Lidocaine 2 %Drug
patients injected with 1ml lidocaine 2%)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | wrists undergoing ultrasound guided perineural injection of 5 ml total volume of injectate (3ml dextrose 5% +1 ml Triamcinolone acetonide + 1 ml lidocaine 2%) for carpel tunnel syndrome Receives: Drug: Dextrose 5%; Drug: Triamcinolone Acetonide (Aristocort® C); Drug: Lidocaine 2 % |
| Group B | Active comparator | wrists undergoing ultrasound guided perineural injection of 10 ml total volume of injectate (8 ml dextrose 5% +1 ml Triamcinolone acetonide + 1 ml lidocaine 2%) for carpel tunnel syndrome Receives: Drug: Dextrose 5%; Drug: Triamcinolone Acetonide (Aristocort® C); Drug: Lidocaine 2 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of pain in patients with Carpal Tunnel Syndrome
Pain assessment through the VAS was explained to the patient (through selection of the number that represents his/her pain with 0 = no pain, and 10 = worst pain
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 posted16 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Kamal Abdullah Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283874
- Sponsor's protocol ID
- volume of injectate CTS
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does it Matter the Volume of Injectate on the Outcome of Ultrasound-guided Perineural Injection for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07283874
- Acronym / sponsor ID
- volume of injectate CTS
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Dec 2025 (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 an entrapment neuropathy affecting the median nerve with a lifetime prevalence of about 8% in the adult population. Carpal tunnel syndrome (CTS) occurs with the symptoms of intermittent nocturnal paresthesia and dysesthesia, followed by loss of sensation, weakness, and thenar muscle atrophy in later stages.
Although the etiology of CTS is multifactorial, compression of the median nerve in a space-limited osteofibrous canal at wrist level was proposed.
The gold standard of diagnosis is electrophysiological study, but ultrasonography was applied in recent decades for a better approach to the morphology change of the median nerve.Nerve hydrodissection (HD) is a widely used technique that involves the injection of fluid to separate the nerve from the surrounding structures.
HD is now considered a novel approach for the treatment of CTS with safe and outstanding long-term effects. A potential benefit of HD is to release the pressure on the "free nerves supplying the main nerves," called "nervi nervorum." Early, the compression of the vasa nervorum would affect venous outflow, causing the accumulation of toxins in the affected part. Then, the lymphatic drainage, located outside the epineurium, would undergo compressive effects.
HD can also decrease the gliding resistance of the median nerve within the carpal tunnel, which is considered a principal patho-mechanical cause of nerve injury.
Hydrodissection HD of the entrapped median nerve is considered a safe and efficacious approach for treatment of mild to moderate CTS and could be offered to patients with severe CTS if surgery is refused or can't be done due to other medical comorbidities. The use of US-guided HD could improve symptom severity, functional status, and the US parameters of nerve entrapment. HD has a long-term efficacy outcome; 88.6% of patients reported an effective outcome, and this may vary according to the initial severity status.
Different types of injectants are available and studied, with no clear indication of use for each type. However, PRP, D5W, and HA were more efficient than NS as regards subjective and objective improvement. PRP and HA were more effective for long-term nerve recovery, while HA was preferred for the earliest response. So, we recommend making the choice based on every patient's severity scale and electrophysiological scales, which means that for patients with mild forms and severe pain.
Injection of a large volume could be a better option in order to dissect a larger area, provide a better environment for the nerve repair mechanisms, and release the vascular and neural compressive elements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dextrose 5%, Drug: Triamcinolone Acetonide (Aristocort® C), Drug: Lidocaine 2 %wrists undergoing ultrasound guided perineural injection of 5 ml total volume of injectate (3ml dextrose 5% +1 ml Triamcinolone acetonide + 1 ml lidocaine 2%) for carpel tunnel syndrome |
| Group B | Active comparator | Drug: Dextrose 5%, Drug: Triamcinolone Acetonide (Aristocort® C), Drug: Lidocaine 2 %wrists undergoing ultrasound guided perineural injection of 10 ml total volume of injectate (8 ml dextrose 5% +1 ml Triamcinolone acetonide + 1 ml lidocaine 2%) for carpel tunnel syndrome |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 20-80 years old 2. Patients diagnosed with idiopathic CTS. 3. Abnormal electrophysiological analysis showing mild to moderate CTS 4. Symptoms and signs including:
Key exclusion criteria (3 listed)
- 1- Age less than 20 years 2- severe CTS (abductor policies brevis muscle atrophy with distal latency time >6.5 MS).
- 3- MN electrophysiology study revealing absent potentials. 4- its cross-sectional area (CSA) >15 mm2 by sonographic checkup. 5- previous surgery of carpal tunnel. 6- previous wrist injection within 3 months 7- history of peripheral nerve injuries (brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome) 8- CTS due to systemic causes, for example, endocrinal and/or pregnancy, rheumatoid arthritis, gouty or psoriatic osteoarthritis.
- 9- concurrent use of antihistaminic, or cortisone. 10- Participant refusal. 11- local infection. presence of coagulopathy, and/or allergy to the included medications were also points for patients' exclusion from the study
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%patients injected with 8ml dextrose 5% | Drug | Group A |
| Dextrose 5%patients injected with 3 ml dextrose 5% | Drug | Group B |
| Triamcinolone Acetonide (Aristocort® C)patients injected with 1 ml Triamcinolone acetonide | Drug | Group A, Group B |
| Lidocaine 2 %patients injected with 1ml lidocaine 2%) | Drug | Group A, Group B |
Primary outcome
the severity of pain in patients with Carpal Tunnel Syndrome
Time frame: 1 month
Pain assessment through the VAS was explained to the patient (through selection of the number that represents his/her pain with 0 = no pain, and 10 = worst pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextrose 5%, Triamcinolone Acetonide (Aristocort® C) and Lidocaine 2 % in people with Carpal Tunnel Syndrome (CTS), run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
the severity of pain in patients with Carpal Tunnel Syndrome (time frame: 1 month). 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 16 Dec 2025.