Carpal Tunnel Syndrome (CTS)NCT07269613
Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome
A study testing Pulsed Radiofrequency and Hyaluronidase Hydrodissection in people with Carpal Tunnel Syndrome (CTS), run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the clinical efficacy and safety of ultrasound-guided pulsed radiofrequency and hyaluronidase hydrodissection in the treatment of carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Pulsed Radiofrequency and Hyaluronidase Hydrodissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2025to Jul 2026
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-80 years
- Clinical diagnosis of CTS with symptoms for at least 3 months
- Electrophysiological evidence of mild to moderate CTS
- No previous intervention for CTS in the affected hand
Who cannot join
- Previous wrist surgery or trauma
- Medical history of polyneuropathy, thoracic outlet syndrome, or brachial plexopathy
- Coagulopathy or local infection at injection site
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine Sohag University
Sohag, Sohag Governorate
Amany Mahmoud Mohamed, resident, 01095062277, amany_mahmoud_post@med.sohag.edu.eg
About this study
Official title: Comparison of Ultrasound Guided Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome, a Prospective, Randomized, Controlled Clinical Study
The aim of this study is to compare the clinical efficacy and safety of ultrasound-guided pulsed radiofrequency and hyaluronidase hydrodissection in the treatment of carpal tunnel syndrome. This research seeks to evaluate both techniques in terms of pain relief, functional improvement, nerve conduction parameters, and potential complications, in order to identify the more effective minimally invasive approach for managing carpal tunnel syndrome.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Pulsed Radiofrequency, Hyaluronidase Hydrodissection
- Keywords
- pulsed radiofrequency versus hyaluronidase hydrodissection for treatment of carpal tunnel syndrome
- 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.
Pulsed RadiofrequencyProcedure or surgery
Pulsed Radiofrequency:
Top neuropole needle 100-mm with a 10-mm active tip will be advanced with
ultrasound guidance using the in-plane technique towards the median nerve.
Sensory and motor stimulation will be tested when the needle is close to the median nerve.
During sensory stimulation (50 Hz; 1-ms pulsed width; 0-3.0 volt), the patients will report paresthesia in the distal fingers.
After performing a motor stimulation (2 Hz; 1-ms pulsed width; 0-3.0 volt), contractions of the thenar muscle will be observed.
PRF lesion will then be carried out for 6 min, pulse width of 5 MS, 5 pulses per second and 35 volts at 42°C.
Hyaluronidase HydrodissectionProcedure or surgery
Hyaluronidase Hydrodissection:
The patient will sit facing the examiner with the forearm supinated and semiflexed at 90°, and the wrist placed on the examination couch with semi extended fingers. The injection for a 5 mL volume of HD 1500 IU will be done under complete sterile conditions. A 26-gauge needle will be introduced from the lateral side toward the midline, using the in-plane approach to target the median nerve in the carpal tunnel using the ulnar approach.
Ultrasonographic visualization of the needle tip will be continuous, the injection was done gradually, and the needle will be advanced dissecting the flexor retinaculum away from the median nerve via gradual drug infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Group A (PRF Group) | Active comparator | Group A (PRF Group): will Receive ultrasound-guided pulsed radiofrequency to the median nerve at the carpal tunnel. Receives: Procedure: Pulsed Radiofrequency |
| Group B (HD Group) | Active comparator | Group B (HD Group): will Receive ultrasound-guided hydrodissection of the median nerve using hyaluronidase solution. Receives: Procedure: Hyaluronidase Hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of significant pain relief
The VAS will be used to quantify pain on the scale of 0 (no pain) to 10 (extremely severe pain). Onset time will be defined as the day when the VAS score declined by 40% or more
Measured: 1 month
Secondary outcomes (3)
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
BCTQ is the most used questionnaire in clinical studies for evaluation of the symptom severity and functional status of patients with CTS [9]. Symptom severity is rated based on 11 questions scored from 1 point (mildest) to 5 points (most severe), and the functional status is evaluated with 8 questions scored from 1 point (no difficulty with activity) to 5 points (cannot perform the activity at all)
Measured: 1 week and 1, 3, 6 months
Cross-sectional area (CSA)
CSA of the median nerve will be measured at the proximal inlet of the carpal tunnel (at the level of the pisiform bone) by the same physician. The patients hold their wrists in a neutral position with the palm up and the fingers semi-extended. CSA will be measured three times, and the mean will be used for the analysis. Typically, a CSA greater than 9-10 mm2 at the wrist is considered suggestive of carpal tunnel syndrome. The ultrasonographic evaluation of median nerve CSA has high sensitivity (89%) and specificity (83%) for the diagnosis of CTS.
This will be done at baseline and then at 1-, 3-, and 6-months post-injection. All measurements will be performed three times, and the mean of the three measurements was used for further statistical analyses
Measured: baseline and then at 1-, 3-, and 6-months
Sensory nerve conduction velocity (SNCV)
The antidromic SNCV of the median nerve will be measured in all subjects. All examinations will be performed by the same physician in the same room maintained at a constant temperature of 25°C. Skin temperature on the hand and wrist will be maintained between 32.0 and 34.0°C. Active and reference ring electrodes will be placed over the 2nd proximal and distal interphalangeal joints. The median nerve will be stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at approximately 14 cm from the active electrode. will performed at baseline and 1, 3, and 6months post-injection.
Measured: baseline and 1, 3, and 6months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (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 Sohag 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, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mahmoud Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269613
- Sponsor's protocol ID
- Soh-Med-25-9-20MS
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel Syndrome, a Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07269613
- Acronym / sponsor ID
- Soh-Med-25-9-20MS
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- pulsed radiofrequency versus hyaluronidase hydrodissection for treatment of carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 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.
The aim of this study is to compare the clinical efficacy and safety of ultrasound-guided pulsed radiofrequency and hyaluronidase hydrodissection in the treatment of carpal tunnel syndrome. This research seeks to evaluate both techniques in terms of pain relief, functional improvement, nerve conduction parameters, and potential complications, in order to identify the more effective minimally invasive approach for managing carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (PRF Group) | Active comparator | Procedure: Pulsed RadiofrequencyGroup A (PRF Group): will Receive ultrasound-guided pulsed radiofrequency to the median nerve at the carpal tunnel. |
| Group B (HD Group) | Active comparator | Procedure: Hyaluronidase HydrodissectionGroup B (HD Group): will Receive ultrasound-guided hydrodissection of the median nerve using hyaluronidase solution. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 20-80 years
- Clinical diagnosis of CTS with symptoms for at least 3 months
- Electrophysiological evidence of mild to moderate CTS
- No previous intervention for CTS in the affected hand
Key exclusion criteria (4 listed)
- Previous wrist surgery or trauma
- Medical history of polyneuropathy, thoracic outlet syndrome, or brachial plexopathy
- Coagulopathy or local infection at injection site
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Pulsed RadiofrequencyPulsed Radiofrequency: Top neuropole needle 100-mm with a 10-mm active tip will be advanced with ultrasound guidance using the in-plane technique towards the median nerve. Sensory and motor stimulation will be tested when the needle is close to the median nerve. During sensory stimulation (50 Hz; 1-ms pulsed width; 0-3.0 volt), the patients will report paresthesia in the distal fingers. After performing a motor stimulation (2 Hz; 1-ms pulsed width; 0-3.0 volt), contractions of the thenar muscle will be observed. PRF lesion will then be carried out for 6 min, pulse width of 5 MS, 5 pulses per second and 35 volts at 42°C. | Procedure or surgery | Group A (PRF Group) |
| Hyaluronidase HydrodissectionHyaluronidase Hydrodissection: The patient will sit facing the examiner with the forearm supinated and semiflexed at 90°, and the wrist placed on the examination couch with semi extended fingers. The injection for a 5 mL volume of HD 1500 IU will be done under complete sterile conditions. A 26-gauge needle will be introduced from the lateral side toward the midline, using the in-plane approach to target the median nerve in the carpal tunnel using the ulnar approach. Ultrasonographic visualization of the needle tip will be continuous, the injection was done gradually, and the needle will be advanced dissecting the flexor retinaculum away from the median nerve via gradual drug infiltration. | Procedure or surgery | Group B (HD Group) |
Primary outcome
Onset time of significant pain relief
Time frame: 1 month
The VAS will be used to quantify pain on the scale of 0 (no pain) to 10 (extremely severe pain). Onset time will be defined as the day when the VAS score declined by 40% or more
3 secondary outcomes
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time frame: 1 week and 1, 3, 6 months
Cross-sectional area (CSA)
Time frame: baseline and then at 1-, 3-, and 6-months
Sensory nerve conduction velocity (SNCV)
Time frame: baseline and 1, 3, and 6months post-injection
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 9 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency and Hyaluronidase Hydrodissection in people with Carpal Tunnel Syndrome (CTS), run by Sohag 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 4 inclusion and 4 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 9 Dec 2025. 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?
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?
Contact Amany Mahmoud Mohamed, resident (01095062277, amany_mahmoud_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time of significant pain relief (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 9 Dec 2025.