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Carpal Tunnel SyndromeNCT07324005

Efficacy of Combining Ultrasound-Guided Needle Release of Transverse Carpal Ligament and Median Nerve Dextrose Water Hydrodissection for Carpal Tunnel Syndrome

A study testing Active Comparator: US-guided D5W perineural hydrodissection alone, group A, Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B and Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C in people with Carpal Tunnel Syndrome and Dextrose, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. There are several treatments for CTS, including conservative and surgical options. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Active Comparator: US-guided D5W perineural hydrodissection alone, group A, Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B and Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTaiwan
Study dates
1 Jan 2026to 31 Dec 2030
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

  • age between 20 to 80 years old
  • diagnosed with CTS on the basis of clinical condition and an electrophysiological analysis
  • the NRS of pain or paresthesia≧3
  • with symptoms lasting for a minimum of 3 months.

Who cannot join

  • history of polyneuropathy, thoracic outlet syndrome, brachial plexopathy, or inflammatory arthropathy
  • onset of CTS during pregnancy, hypothyroidism, or systemic infection
  • previous corticosteroid injection or wrist surgery for CTS
  • hypersensitivity to dextrose injection
  • the anatomic structure of the wrist is not suitable for needle release of TCL.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei

    Lin-Fen Hsieh, M.D., +886-28332211 ext. 2538, M001026@ms.skh.org.tw

    Recruiting

Other trials in Taiwan

About this study

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. There are several treatments for CTS, including conservative and surgical options. Though local corticosteroid injection has been considered more effective than physical therapy for treatment of CTS and has significant short-term benefits, long term benefits are not evidenced. Several studies in recent years reported significantly superior longer-term benefit of D5W and PRP compared with corticosteroid injections and other conservative managements. In addition, percutaneous release of the transverse carpal ligament (TCL) was developed to treat CTS in recent years. Because the effectiveness of the recently developed techniques in treating CTS has not been well established, the investigators aim to investigate whether combining US-guided partial release of the transverse carpal ligament with a needle plus D5W hydrodissection is more beneficial for CTS comparing to either treatment alone.

Read the detailed description

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. The prevalence of CTS ranges from 3% to 7.43%, and it carries a significant economic burden, influencing the number of workdays lost. Risk factors for CTS include occupations that need repetitive hand movements, female gender, age, pregnancy, obesity, diabetes, and specific anatomical and physiological traits. The symptoms and signs of CTS include tingling, numbness, nocturnal paresthesia, and pain in the median nerve distribution, whereas thenar atrophy and weakness of grasping manifest in the late stages. The widely-accepted pathophysiology includes increased pressure in the carpal tunnel, median nerve microcirculation injury, synovial tissue hypertrophy, and connective tissue compression of the median nerve. The interactions of mechanisms can lead to venous outflow obstruction, edema, and then ischemia and nerve injury ultimately. The diagnosis of CTS is made via the patient's history and physical examination, and electrodiagnostic tests may be done to differentiate among diagnoses. In recent years ultrasonographic image study of the median nerve can be applied in the evaluation and/or diagnosis of CTS. There are several treatments for CTS, including conservative and surgical options. For mild to moderate CTS, non-surgical treatments such as splinting, physical therapy, ultrasound (US)-guided corticosteroid injection, oral medications, and manual therapies are recommended. Although a systemic review showed that surgical approach yield better midterm and long term outcomes than conservative managements, there are some complications of open carpal tunnel release, including neuroma of the palmar cutaneous branch of the median nerve, infection, hypertrophic scars, postoperative pain, and persistent or recurrent symptoms. Therefore, surgical treatment is recommended only after 7 conservative management failure, or for more severe CTS.

Though local corticosteroid injection has been considered more effective than physical therapy for treatment of CTS and has significant short term benefits, long term benefits are not evidenced. In the recent decade, ultrasound guided regenerative medicine was developed to treat CTS, among which five percent dextrose in water (D5W) and platelet-rich plasma (PRP) are two commonly used injectates. Several studies in recent years reported significantly superior longer-term benefit of D5W and PRP compared with corticosteroid injections and other conservative managements. The mechanism of regenerative medicine for CTS can be divided into pharmacological and mechanical effects. The pharmacological effect includes initiating tissue proliferation in the absence of inflammation, whereas the mechanical effect can be refer to hydrodissection. In addition, percutaneous release of the transverse carpal ligament (TCL) was developed to treat CTS in recent years.

Acupotomy, using a needle-knife derived from traditional Chinese medicine to release TCL and promote local blood circulation, is a safe and effective option when performed via ultrasound guidance. Other than using a needle-knife, partial release of TCL with a needle is another choice. In a prospective study in 2022, ultrasound guided partial release of TCL using an 18-G needle was done in patients with CTS, and the result revealed that 86.2% wrists showed successful treatment outcomes at 6 months after intervention. Another cohort study in 2024 showed that treating severe CTS with ultrasound-guided partial release of TCL using a 21-G curved needle resulted in improved outcomes at the 6-week follow-up. Because the effectiveness of the recently developed techniques in treating CTS has not been well established, the investigators aim to investigate whether combining US-guided partial release of the transverse carpal ligament with a needle plus D5W hydrodissection is more beneficial for CTS comparing to either treatment alone. The investigators hypothesize that adding percutaneous release of the TCL to D5W hydrodissection could bring more therapeutic effects.

Being tested
Active Comparator: US-guided D5W perineural hydrodissection alone, group A, Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B, Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C
Keywords
Carpal Tunnel Syndrome, dextrose, carpal tunnel release, ultrasound, nerve hydrodissection therapy
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.

  • Active Comparator: US-guided D5W perineural hydrodissection alone, group AProcedure or surgery

    Patients in the group A will receive 1 session of ultrasound-guided perineural injection with 5ml D5W.

  • Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group BProcedure or surgery

    Patients in the group B will receive 1 session of ultrasound-guided partial release of the TCL with a needle plus D5W injection to TCL.

  • Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group CProcedure or surgery

    Patients in the group C will receive 1 session of the treatment combining group A and group B. Hydrodissection of the median nerve will be performed before TCL release.

Study groups in NCT07324005
Study groupRoleWhat they receive
US-guided D5W perineural hydrodissection alone, group AActive comparatorPatients in the group A will receive 1 session of ultrasound-guided perineural injection with 5ml D5W.
Receives: Procedure: Active Comparator: US-guided D5W perineural hydrodissection alone, group A
US guided partial release of the TCL with a needle + D5W injection (to TCL), group BActive comparatorPatients in the group B will receive 1 session of ultrasound-guided partial release of the TCL with a needle plus D5W injection to TCL.
Receives: Procedure: Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B
US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissectionActive comparatorPatients in the group C will receive 1 session of the treatment combining group A and group B.
Receives: Procedure: Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

    The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a widely applied patient-reported tool for assessing the severity of carpal tunnel syndrome. This instrument consists of two sections: the Symptom Severity Scale (SSS), comprising 11 questions, and the Functional Status Scale (FSS), containing 8 items. Both scales use a 1 to 5 rating system. The minimum score is 19, and maximum value is 95. Higher scores mean a worse outcome.

    Measured: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

Secondary outcomes (5)
  1. Numeric rating scale (NRS)

    Pain or paresthesia severity will be assessed using the NRS, ranging from 0 (no pain and no paresthesia) to 10 (the worst imaginable pain or abnormal sensation).

    Measured: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

  2. Cross-sectional area (CSA)

    Cross-sectional area (CSA) of the median nerve: The CSA of the median nerve will be assessed with an freehand tracing tool at the level of the scaphoid-pisiform, a site where median nerve swelling provides a consistent parameter for post-injection monitoring. Each measurement will be performed three times, and the average value is used for subsequent analysis.

    Measured: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

  3. Electrophysiological measurement

    Assessment of the antidromic sensory nerve conduction velocity (SNCV) and distal motor latency (DML) of the median nerve will be conducted following established protocols. For SNCV measurement, surface electrodes is placed over the proximal and distal interphalangeal joints of the second digit, serving as the active and reference electrodes, respectively, with electrical stimulation applied 14 cm proximal to the active electrode along the course of the median nerve. For DML evaluation, the active electrode is positioned over the abductor pollicis brevis muscle, while the reference electrode is placed at the distal muscle-tendon junction; the median nerve is stimulated 8 cm proximal to the active electrode.

    Measured: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

  4. Tip pinch strength

    Tip pinch strength, defined as the contact between the thumb pulp and index finger pulp, was assessed using a calibrated B\&L pinch meter (B\&L Engineering). Participants were seated with the shoulder adducted and in a neutral rotational position, the elbow flexed at 90 degrees, and the forearm and wrist placed in pronation to facilitate the measurement. Each subject performed three maximum-effort trials, with a one-minute rest period between each trial to prevent muscle fatigue. The mean value from the three trials was calculated for further analysis.

    Measured: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

  5. Self-assessment of the treatment effect

    Self-assessment of the treatment effect All participants provided self reported evaluations of the treatment effect at 1, 3, and 6 months following the injection, using a 5-point Likert scale: much improved, improved, no change, worse, or much worse. Responses of "much improved" or "improved" were classified as indicating a positive treatment outcome. (This item is not evaluated at baseline.).

    Measured: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324005
Sponsor's protocol ID
20250714R
Status last verified
Apr 2026
First submitted
22 Dec 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator: US-guided D5W perineural hydrodissection alone, group A, Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B and Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C in people with Carpal Tunnel Syndrome and Dextrose, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

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 5 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 Taiwan. 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 Lin-Fen Hsieh (+886-28332211 ext. 2538, M001026@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) (time frame: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.). 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 23 Apr 2026.

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