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Carpal Tunnel SyndromeKTSNCT07207460

Hydrodissection in Carpal Tunnel Syndrome

A study testing Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS in people with Carpal Tunnel Syndrome and Median Nerve Entrapment, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to compare the effectiveness of perineural hydrodissection methods performed with 5 mL D5W solution and three different injection techniques [ultrasound-guided in-plane, ultrasound-guided out-of-plane, and blind technique] in cases diagnosed with mild to moderate CTS by EMG. Read more about this study

Who is it for?
Ages 20 to 70 years
What is being tested?
Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2024to 1 Aug 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between the ages of 20-70
  • Moderate and mild CTS patients diagnosed with CTS by EMG
  • Literate patients who agreed to participate in the study

Who cannot join

  • Patients with RA, type 1 or type 2 diabetes mellitus
  • Patients with chronic renal failure
  • Polyneuropathy
  • Those with a history of cancer, those receiving chemotherapy
  • Those with a history of broken hand wrist fracture in the last 6 months
  • Patients with brachial plexopathy or thoracic outlet syndrome (TOS)
Show all 12Show fewer
  • Patients who underwent surgery due to CTS
  • Pregnancy
  • Hypothyroidism in a mixed edema picture
  • Diagnosed with neuromuscular disease
  • Patients with bleeding disorders or those currently receiving anticoagulant therapy
  • patients with infection at the injection site

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Hydrodissection Techniques Using 5% Dextrose for the Treatment of Carpal Tunnel Syndrome

The aim of this study was to compare the effectiveness of perineural hydrodissection methods performed with 5 mL D5W solution and three different injection techniques [ultrasound-guided in-plane, ultrasound-guided out-of-plane, and blind technique] in cases diagnosed with mild to moderate CTS by EMG.

Read the detailed description

Carpal tunnel syndrome (CTS) is a highly prevalent condition in the general population, markedly impairing daily activities and sleep quality. Depending on disease severity and symptom burden, treatment approaches are broadly categorized as conservative or surgical. Beyond lifestyle modifications, numerous conservative interventions-including splinting, extracorporeal shock wave therapy, therapeutic ultrasound, phonophoresis, hydrodissection, kinesiotaping, corticosteroid (CS) injections, low-level laser therapy, platelet-rich plasma (PRP) injections, manual therapy, and acupuncture-have demonstrated clinical efficacy. More recently, 5% dextrose injections have emerged as a safe alternative to CS with minimal adverse effects. Injection therapies vary in both content and technique; however, no consensus exists regarding the optimal approach. Given the importance of minimizing side effects and ensuring long-term effectiveness, the refinement of injection agents and techniques remains a priority. Although ultrasound-guided injections improve safety and accuracy, they require expertise and incur additional costs, whereas blind techniques have long been applied reliably in clinical practice. Nevertheless, comparative studies evaluating these techniques remain limited. Therefore, the present study aimed to compare three different injection techniques for the management of CTS.

Being tested
Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS
Keywords
Carpal Tunnel Syndrome, perineural injection, nerve hydrodissection, Conservative treatment, Entrapment neuropathy, 5% dextrose, ultrasound-guided hydrodissection
Medical subject headings
Carpal Tunnel Syndrome, Median Neuropathy, Charcot-Marie-Tooth Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTSProcedure or surgery

    Also called land-mark technique, ultrasound-guided injection technique

    Comparison of three different injection techniques with D5W

Study groups in NCT07207460
Study groupRoleWhat they receive
ultrasound-guided in-plane injection techniqueActive comparatorWith the patient seated, the lower third of the forearm and the entire palm were sterilized using 2% povidone-iodine. A sterile cover was applied to the ultrasound probe, and sterile gel was placed on the skin. The probe was positioned transversely at the palmar wrist crease at the entrance of the carpal tunnel, allowing visualization of the pisiform, ulnar nerve, and ulnar artery . The ulnar nerve lies just radial to the pisiform, with the ulnar artery located radial to the ulnar nerve; Doppler imaging was used when necessary to confirm arterial position. After identifying the median nerve with ultrasound, a 22-gauge, 38 mm needle was advanced via the ulnar approach. The ulnar nerve and artery were visualized throughout the procedure. The needle was first advanced to the inferior surface of the median nerve with the bevel facing upward; following negative aspiration, 2.5 mL of 5% dextrose solution was injected. Without removing the needle from the skin, the bevel was then r
Receives: Procedure: Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS
ultrasound-guided out-of-plane injection techniqueActive comparatorThe patient was seated, and the lower third of the forearm and the entire palm were sterilized with 2% povidone-iodine. A sterile drape covered the ultrasound probe, and sterile gel was applied to the skin. The probe was placed transversely at the proximal wrist crease to visualize the median nerve, then shifted ulnarly to identify the pisiform, ulnar nerve, and ulnar artery. Doppler imaging was used when necessary to confirm arterial position. For the out-of-plane technique, a proximal-to-distal longitudinal approach was employed. With the median nerve visualized, a 22-gauge, 38 mm needle was inserted, and after negative aspiration, 5 mL of 5% dextrose solution was injected between the median nerve and the flexor retinaculum
Receives: Procedure: Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS
blind techniqueActive comparatorThis injection technique relies on anatomical landmarks, targeting the space between the palmaris longus tendon and the flexor carpi radialis. The patient was seated, and the lower third of the forearm and the entire palm were sterilized using 2% povidone-iodine. The most commonly used landmarks for the blind approach were the ulnar edge of the palmaris longus tendon and the proximal wrist crease. A 22-gauge, 38 mm needle was inserted at the ulnar border of the palmaris longus tendon along the scaphoid-pisiform line and advanced distally toward the ring finger at an angle of approximately 30°-45°. In patients lacking a palmaris longus tendon, the needle was inserted just ulnar to the wrist midline. Upon patient-reported paresthesia, the needle was slightly withdrawn and redirected ulnarly. Aspiration was performed in all cases to avoid intravascular injection, and 5 mL of 5% dextrose solution was administered slowly and steadily.
Receives: Procedure: Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS

What is being measured

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

  1. Boston CTS

    The BCTQ is the most widely used measure for CTS. It includes 2 subscales with 11 questions assessing symptom severity and 8 questions assessing functional status.31 Scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.The BCTQ provides a standardized, patient-based outcome measure of symptom severity and functional status to assess the results of carpal tunnel syndrome treatments. The test has strong evidence of validity, reliability and responsiveness.

    Measured: 0 , 2nd week 12th week

  2. VAS

    VAS was used to assess digital pain intensity and paresthesia/dysthesia before injection therapy administration. Scores ranged from 10 (extremely severe pain) to 0 (no pain).

    Measured: 0 2nd week 12th week

  3. DN-4

    It is a clinical screening tool used to diagnose the presence of neuropathic pain.It was developed by the French Neuropathic Pain Group to address the difficulties and lack of consensus in diagnosing neuropathic pain.It is a questionnaire consisting of 10 items administered by the clinician.Seven pain-related items (i.e., sensory and pain descriptors) are administered in consultation with the patient. They express how pain is felt by the patient.The three items are based on clinical examination. The clinician assesses whether sensation to touch or pinprick is diminished (hyposthesia) and whether it increases with light brushing or causes pain (allodynia).

    Measured: 0 2nd week 12th week

Secondary outcomes (2)
  1. Nerve CSA

    The cross-sectional area (CSA) of the median nerve was measured at baseline, 2 weeks, and 3 months after injection by a physician with over 10 years of ultrasound experience. Patients were seated with the forearm supinated and the wrist in slight dorsiflexion, supported by a rolled towel or pillow. A high-frequency linear probe (5-12 MHz, Logic P5, GE Medical Systems) was placed on the palmar wrist in the transverse plane. The median nerve was identified at the level of the scaphoid (radial side) and pisiform (ulnar side), typically in the midline beneath the superficial flexor tendons. CSA was measured by tracing the inner border of the perineural echogenic rim. Each measurement was repeated three times, and the mean value was recorded.

    Measured: 0 2nd 12th week

  2. EMG

    Using electrophysiological studies, CTS degree (distal motor latency [DML]) greater than 3.6 was considered as moderate CTS, and those less than 3.6 as mild CTS. Only participants with mild-to-moderate CTS were included in the study.

    Measured: 0 and 12th week

Timeline

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

  1. First posted6 Oct 2025
  2. Study start1 Jan 2024
  3. Primary completion1 May 2025
  4. Study completion1 Aug 2025

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
Model description
This study was designed as a randomized, controlled, single-blind trial. Patients diagnosed with mild or moderate CTS based on EMG findings were randomly assigned into three groups using a computerized randomization method. Perineural hydrodissection was performed with 5 mL of 5% dextrose solution in all groups: Group 1 with the in-plane US-guided ulnar approach, Group 2 with the out-of-plane US-guided proximal-to-distal ulnar approach, and Group 3 with the blind proximal-to-distal longitudinal approach. Assessments were conducted at baseline, 2 weeks, and 3 months after the injection. Outcome measures included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the DN4 questionnaire for CTS severity and functional status, as well as pain intensity assessed using a Visual Analog Scale (VAS). Median nerve cross-sectional area (CSA) was measured at baseline by a physician with over 10 years of US experience, and electromyography (EMG) evaluations were performed at baseline and 3 m
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07207460
Sponsor's protocol ID
E2-23-4769
Acronym
KTS
Status last verified
Sep 2025
First submitted
17 Sep 2025
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mathieu T, Lemmens E, Stassijns G. A safe and easy-to-use ultrasound-guided hydrodissection technique for the carpal tunnel syndrome: a minimally invasive approach. J Ultrasound. 2022 Sep;25(3):451-455. doi: 10.1007/s40477-021-00597-5. Epub 2021 Jul 2.

    PubMed 34213741
  • Babaei-Ghazani A, Roomizadeh P, Forogh B, Moeini-Taba SM, Abedini A, Kadkhodaie M, Jahanjoo F, Eftekharsadat B. Ultrasound-Guided Versus Landmark-Guided Local Corticosteroid Injection for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Apr;99(4):766-775. doi: 10.1016/j.apmr.2017.08.484. Epub 2017 Sep 21.

    PubMed 28943161
  • Lee K, Park JM, Yoon SY, Kim MS, Kim YW, Shin JI, Lee SC. Ultrasound-Guided Nerve Hydrodissection for the Management of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Yonsei Med J. 2025 Feb;66(2):111-120. doi: 10.3349/ymj.2024.0089.

    PubMed 39894044
  • Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.

    PubMed 30187524
  • Lee JY, Park Y, Park KD, Lee JK, Lim OK. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study. Medicine (Baltimore). 2014 Dec;93(29):e350. doi: 10.1097/MD.0000000000000350.

    PubMed 25546691
  • Babaei-Ghazani A, Forogh B, Raissi GR, Ahadi T, Eftekharsadat B, Yousefi N, Rahimi-Dehgolan S, Moradi K. Ultrasound-Guided Corticosteroid Injection in Carpal Tunnel Syndrome: Comparison Between Radial and Ulnar Approaches. J Pain Res. 2020 Jun 26;13:1569-1578. doi: 10.2147/JPR.S248600. eCollection 2020.

    PubMed 32617017
  • Buntragulpoontawee M, Chang KV, Vitoonpong T, Pornjaksawan S, Kitisak K, Saokaew S, Kanchanasurakit S. The Effectiveness and Safety of Commonly Used Injectates for Ultrasound-Guided Hydrodissection Treatment of Peripheral Nerve Entrapment Syndromes: A Systematic Review. Front Pharmacol. 2021 Mar 5;11:621150. doi: 10.3389/fphar.2020.621150. eCollection 2020.

    PubMed 33746745
  • Cage ES, Beyer JJ, Ebraheim NA. Injections for treatment of carpal tunnel syndrome: A narrative review of the literature. J Orthop. 2023 Feb 21;37:81-85. doi: 10.1016/j.jor.2023.02.011. eCollection 2023 Mar.

    PubMed 36974095
  • Borire AA, Hughes AR, Lueck CJ, Colebatch JG, Krishnan AV. Sonographic differences in carpal tunnel syndrome with normal and abnormal nerve conduction studies. J Clin Neurosci. 2016 Dec;34:77-80. doi: 10.1016/j.jocn.2016.05.024. Epub 2016 Jul 25.

    PubMed 27469410

Questions about this trial

What is this clinical trial studying?

A study testing Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS in people with Carpal Tunnel Syndrome and Median Nerve Entrapment, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

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 3 inclusion and 12 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 6 Oct 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 Turkey (Türkiye). 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?

Boston CTS (time frame: 0 , 2nd week 12th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07207460, which also lists 9 linked publications.

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 6 Oct 2025.

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