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Carpal Tunnel Syndrome (CTS)NCT07839611

Combined Stellate Ganglion Block With Median Nerve Hydrodissection Versus Median Nerve Hydrodissection Only in Carpal Tunnel Syndrome

A study testing combined stellate ganglion block procedure and median nerve hydrodissection and Ultrasound-Guided Median Nerve Hydrodissection Procedure only in people with Carpal Tunnel Syndrome (CTS), run by Fayoum University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

the study aims to compare clinical and electrophysiological outcomes of combined stellate ganglion block plus median nerve hydrodissection versus hydrodissection alone in carpal tunnel syndrome, assessing pain, function, autonomic predictors, and safety over time. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
combined stellate ganglion block procedure and median nerve hydrodissection and Ultrasound-Guided Median Nerve Hydrodissection Procedure only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Sep 2026to Sep 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years or older.
  • Patients diagnosed with carpal tunnel syndrome based on compatible clinical symptoms and signs.
  • Diagnosis confirmed by nerve conduction studies/electrodiagnostic testing.
  • Patients with mild to moderate carpal tunnel syndrome.
  • Patients with persistent symptoms despite conservative treatment.
  • Patients eligible for ultrasound-guided median nerve hydrodissection.
  • Patients willing to participate in the study and provide written informed consent.

Who cannot join

  • Previous surgical treatment for carpal tunnel syndrome in the affected hand.
  • Severe carpal tunnel syndrome with marked thenar muscle wasting or severe axonal loss.
  • Coexisting cervical radiculopathy or peripheral polyneuropathy.
  • Previous fracture, major trauma, or surgery involving the affected wrist or hand.
  • Other neurological or musculoskeletal conditions affecting the symptoms or functional assessment of the affected upper limb.
  • Local infection, inflammation, or skin lesion at the injection site.
Show all 9Show fewer
  • Known bleeding disorder or contraindication to the injection procedure.
  • Current anticoagulant therapy that contraindicates the procedure.
  • Known allergy or contraindication to any medication used during the intervention.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

zeyad nabil researcher, master's reseacher contact

+20 01067112822

zeyadnabil555@gmail.com

About this study

Official title: Combined Stellate Ganglion Block With Median Nerve Hydrodissection Versus Median Nerve Hydrodissection Only in Carpal Tunnel Syndrome: A Randomised Controlled Study

the study aims to compare clinical and electrophysiological outcomes of combined stellate ganglion block plus median nerve hydrodissection versus hydrodissection alone in carpal tunnel syndrome, assessing pain, function, autonomic predictors, and safety over time.

Read the detailed description

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy, caused by compression of the median nerve at the wrist, and remains a substantial healthcare burden. Population prevalence is estimated at 1-5%, and approximately 10% of individuals experience CTS during their lifetime .Beyond symptoms of pain, paresthesia, and weakness, CTS contributes meaningfully to work disability, reduced quality of life, and ongoing functional limitation, with many patients reporting persistent symptoms despite treatment . Its importance is amplified by rising prevalence in aging populations particularly among individuals aged 50-54 and 75-84 years and by associations with contemporary occupational exposures such as prolonged computer use Current evidence indicates that CTS pathophysiology is multifactorial, extending beyond simple mechanical compression to include impaired median nerve excursion and a clinically relevant autonomic component involving sympathetic nervous system dysfunction . Autonomic manifestations are not rare; they have been reported in 47-55% of patients and appear associated with greater disease severity . Mechanistic work also supports sympathetic activation in CTS, with biomarkers of stress and sympathetic activity correlating with pain intensity, suggesting that sympathetic dysregulation may contribute to symptom persistence and incomplete response to standard interventions. In parallel with improved understanding of mechanisms, treatment options have expanded. Ultrasound-guided median nerve hydrodissection, using 5% dextrose has emerged as an effective minimally invasive approach separating the nerve from surrounding tissues and reducing perineural irritation. Prospective trials and clinical studies demonstrate meaningful improvements in pain, function, and electrodiagnostic parameters at 3-6 months of follow-up]. More broadly, standard care includes both injection-based therapies and surgery, and recent high quality evidence (the 2025 DISTRICTS trial) indicates that surgical intervention provides superior long-term outcomes compared with corticosteroid injection, although both remain widely used.Contemporary clinical practice guidelines continue to emphasize evidence-based, stepwise management However despite these advances a key therapeutic gap remains. To date, no studies have evaluated whether combining stellate ganglion block (SGB) with median nerve hydrodissection provides additive or synergistic benefit compared with hydrodissection alone in CTS. Hydrodissection primarily targets local mechanical interfaces and perineural inflammation whereas SGB produces a cervical sympathetic blockade that can modulate upper extremity sympathetic outflow and has demonstrated benefit in sympathetically maintained pain and neuropathic pain phenotypes through sympathetic modulation, anti-inflammatory effects, and improved regional perfusion . The persistence of autonomic dysfunction in a large subset of CTS patients (47-55%), and evidence linking sympathetic activation to symptom burden, underscores the possibility that treating mechanical factors alone may leave an important driver of symptoms undertreated Moreover, autonomic fiber dysfunction has been implicated as a potential contributor to persistent symptoms and incomplete recovery, including after definitive interventions . Accordingly, this randomized controlled study investigates whether addressing both components of CTS local median nerve pathology and sympathetic dysregulation can improve outcomes. The primary aim is to determine whether combined SGB with median nerve hydrodissection yields superior clinical results compared with median nerve hydrodissection alone. Specifically, we will compare pain reduction, functional improvement, and nerve conduction parameters between groups at different time points and evaluate whether baseline autonomic symptoms predict differential treatment response, and assess safety and adverse events across both arms. By integrating sympathetic modulation with ultrasound-guided nerve decompression, this trial is designed to directly address a previously neglected mechanistic domain in CTS and may help identify a clinically meaningful subgroup patients with prominent autonomic features who derive particular benefit from sympathetic blockade . If effective, this combined strategy could represent a pragmatic, minimally invasive treatment paradigm with potential to improve outcomes in treatment-resistant cases and reduce progression to surgery .

Being tested
combined stellate ganglion block procedure and median nerve hydrodissection, Ultrasound-Guided Median Nerve Hydrodissection Procedure only
Keywords
stellate ganglion block, median nerve hydrodissection
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.

  • combined stellate ganglion block procedure and median nerve hydrodissectionProcedure or surgery

    Stellate Ganglion Block - Brief Technique Patient supine, neck slightly extended and turned away. Use ultrasound guidance at the C6 level. Identify the carotid artery, thyroid, longus colli muscle, and C6 transverse process.

    Insert the needle in-plane, avoiding vessels, toward the prevertebral fascia over the longus colli.

    After aspiration and confirmation of position, inject a small volume of local anesthetic.

    Observe for successful block, typically ipsilateral Horner syndrome (ptosis, miosis, facial anhidrosis).

    Monitor for complications such as vascular injection, hematoma, hoarseness, LAST, and airway compromise.

  • Ultrasound-Guided Median Nerve Hydrodissection Procedure onlyProcedure or surgery

    Ultrasound-Guided Median Nerve Hydrodissection - Brief Technique Position the patient with the forearm supinated. Use a high-frequency linear ultrasound probe to identify the median nerve. Scan the nerve in short axis and identify surrounding vessels and tendons. Insert the needle in-plane, keeping the tip continuously visible. Advance the needle adjacent to the median nerve, without entering the nerve. Inject a small amount of fluid to open the tissue plane around the nerve, then continue injection to achieve circumferential hydrodissection.

    Confirm separation of the nerve from surrounding structures on ultrasound. Monitor for pain, paresthesia, vascular puncture, or nerve injury. The total injected volume ranged from 5 to 10 mL for standard hydrodissection without steroid. Either normal saline or 5 percent dextrose in water was used,

Study groups in NCT07839611
Study groupRoleWhat they receive
combined stellate ganglion block with median nerve hydrodissectionExperimentalthese patients will recieve combined ultrasound-guided stellate ganglion block (SGB) plus ultrasound-guided median nerve hydrodissection Stellate Ganglion Block Patient supine, neck slightly extended and turned away. Use ultrasound guidance at the C6 level. Identify the carotid artery, thyroid, longus colli muscle, and C6 transverse process. Insert the needle in-plane, avoiding vessels, toward the prevertebral fascia over the longus colli. After aspiration and confirmation of position, inject a small volume of local anesthetic. Observe for successful block, typically ipsilateral Horner syndrome (ptosis, miosis, facial anhidrosis Ultrasound-Guided Median Nerve Hydrodissection Position the patient with the forearm supinated Use a high-frequency linear ultrasound probe to identify the median nerve. Scan the nerve in short axis and identify surrounding vessels Inject a small amount of fluid to open the tissue plane around the nerve, then continue injection to achieve hydrodissection
Receives: Procedure: combined stellate ganglion block procedure and median nerve hydrodissection
median nerve hydrodissection onlyActive comparatorthese patients will recieve only ultrasound guided median nerve hydrodissection only as follow Ultrasound-Guided Median Nerve Hydrodissection Position the patient with the forearm supinated. Use a high-frequency linear ultrasound probe to identify the median nerve. Scan the nerve in short axis and identify surrounding vessels and tendons. Insert the needle in-plane, keeping the tip continuously visible. Advance the needle adjacent to the median nerve, without entering the nerve. Inject a small amount of fluid to open the tissue plane around the nerve, then continue injection to achieve circumferential hydrodissection. Confirm separation of the nerve from surrounding structures on ultrasound.
Receives: Procedure: Ultrasound-Guided Median Nerve Hydrodissection Procedure only

What is being measured

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

  1. Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 12 Weeks

    The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) consists of 11 items, each scored from 1 to 5. The overall score is calculated as the mean of the 11 item scores, ranging from 1 to 5. Higher scores indicate greater symptom severity (worse outcome). The outcome is the change from baseline to the specified follow-up time point.

    Measured: baseline to 12 weeks

Secondary outcomes (12)
  1. Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 4 Weeks

    The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) consists of 11 items, each scored from 1 to 5. The overall score is calculated as the mean of the 11 item scores, ranging from 1 to 5. Higher scores indicate greater symptom severity (worse outcome). The outcome is the change from baseline to the specified follow-up time point.

    Measured: from baseline to 4 weeks

  2. Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 8 Weeks

    The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) consists of 11 items, each scored from 1 to 5. The overall score is calculated as the mean of the 11 item scores, ranging from 1 to 5. Higher scores indicate greater symptom severity (worse outcome). The outcome is the change from baseline to the specified follow-up time point.

    Measured: from baseline to 8 weeks

  3. Change in Visual Analog Scale for Pain Score from Baseline to 4 Weeks

    Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome).

    Measured: from baseline to 4 weeks

  4. Change in Visual Analog Scale (VAS) for Pain Score from Baseline to 8weeks

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity (worse outcome). The outcome is the change from baseline to the specified follow-up time point

    Measured: baseline to 8 weeks

  5. Change in Visual Analog Scale (VAS) for Pain Score from Baseline to 12 Weeks

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity (worse outcome). The outcome is the change from baseline to the specified follow-up time point

    Measured: baseline to 12weeks

  6. Change in Boston Carpal Tunnel Questionnaire Functional Status Scale Score from Baseline to 4 Weeks

    The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) consists of 8 items, each scored from 1 to 5. The overall score is calculated as the mean of the 8 item scores, ranging from 1 to 5. Higher scores indicate greater functional impairment (worse outcome). The outcome is the change from baseline to the specified follow-up time point.

    Measured: baseline to 4 weeks

  7. Change in Boston Carpal Tunnel Questionnaire Functional Status Scale Score from Baseline to 8 Weeks

    The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) consists of 8 items, each scored from 1 to 5. The overall score is calculated as the mean of the 8 item scores, ranging from 1 to 5. Higher scores indicate greater functional impairment (worse outcome). The outcome is the change from baseline to the specified follow-up time point.

    Measured: baseline to 8 weeks

  8. Change in Boston Carpal Tunnel Questionnaire Functional Status Scale Score from Baseline to 12 Weeks

    between-group difference in change in BCTQ Functional Status Scale (BCTQ-FSS) score. 8 items, each 1 to 5, mean range 1 to 5, higher = greater functional limitation (worse outcome).

    Measured: baseline to 12weeks

  9. number of participants requiring additional intervention during the 12 weeks follow up

    the number of participants requiring additional intervention for carpal tunnel syndrome during the 12 weeks follow up period will be recorded.

    additional intervention will be defined as any further therapeutic intervention for persistent or recurrent carpal tunnel syndrome symptoms after the study intervention

    Measured: 12 weeks

  10. Time to Recurrence of Carpal Tunnel Syndrome Symptoms During 12 Weeks Follow up

    Description: Time in days from study intervention to recurrence of symptoms, recorded during 12 weeks follow-up. Recurrence defined as return of symptoms after initial improvement.

    Measured: 12 weeks

  11. Number of Participants with a Positive Phalen's Test at 12 Weeks

    Number of participants with positive Phalen's test in each group at 12 weeks. Positive defined as reproduction of symptoms in median nerve distribution during wrist flexion.

    Measured: 12 weeks

  12. Number of Participants with a Positive Tinel's Test at 12 Weeks

    Number of participants with positive Tinel's test in each group at 12 weeks. Positive defined as reproduction of symptoms in median nerve distribution following percussion over carpal tunnel.

    Measured: 12 weeks

Timeline

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

  1. First posted24 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (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
Model description
This study is a prospective, randomized, two-arm interventional clinical trial comparing combined ultrasound-guided stellate ganglion block (SGB) plus ultrasound-guided median nerve hydrodissection (Group A) versus ultrasound guided median nerve hydrodissection alone (Group B) in adults with mild-moderate carpal tunnel syndrome (CTS). The trial will be conducted at Fayoum University Hospital, Department of Pain Medicine and Anesthesia, after Institutional Review Board (IRB) approval. Written informed consent will be obtained from all participants prior to enrollment.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07839611
Sponsor's protocol ID
M892
Status last verified
Aug 2026
First submitted
26 Aug 2026
Last updated
24 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • A Sousa LH, Costa CO, Novak EM, Giostri GS. Complex Regional Pain Syndrome after Carpal Tunnel Syndrome Surgery: A Systematic Review. Neurol India. 2022 Mar-Apr;70(2):491-503. doi: 10.4103/0028-3886.344616.

    PubMed 35532609
  • Bland JDP. Hydrodissection for treatment of carpal tunnel syndrome. Muscle Nerve. 2018 Jan;57(1):4-5. doi: 10.1002/mus.25759. Epub 2017 Aug 21. No abstract available.

    PubMed 28786115
  • Huang CY, Lai CY, Reeves KD, Lam KHS, Li TY, Cheng CI, Wu YT. Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome: A Prospective, Randomized, and Single-Blind Study. J Ultrasound Med. 2024 Jan;43(1):161-169. doi: 10.1002/jum.16349. Epub 2023 Oct 24.

    PubMed 37873682
  • 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
  • Pokharel S, Silwal S, Shrestha P, Neupane K. Ultrasound Guided Hydrodissection of Median Nerve with the Use of 5% Dextrose in Carpal Tunnel Syndrome: A Case Report. JNMA J Nepal Med Assoc. 2024 Sep;62(277):611-613. doi: 10.31729/jnma.8751. Epub 2024 Sep 30.

    PubMed 40655054

Questions about this trial

What is this clinical trial studying?

A study testing combined stellate ganglion block procedure and median nerve hydrodissection and Ultrasound-Guided Median Nerve Hydrodissection Procedure only in people with Carpal Tunnel Syndrome (CTS), run by Fayoum 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 7 inclusion and 9 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 24 Sep 2026. 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.

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 zeyad nabil researcher, master's reseacher (+20 01067112822, zeyadnabil555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 12 Weeks (time frame: baseline to 12 weeks). 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 NCT07839611, which also lists 5 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 24 Sep 2026.

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