An interventional study of combined stellate ganglion block procedure and median nerve hydrodissection and Ultrasound-Guided Median Nerve Hydrodissection Procedure only in Carpal Tunnel Syndrome (CTS), sponsored by Fayoum University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Fayoum University · Not applicable, Interventional, and Treatment
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.
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 .
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
these 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
Procedure: combined stellate ganglion block procedure and median nerve hydrodissection
these 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.
Procedure: Ultrasound-Guided Median Nerve Hydrodissection Procedure only
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 - 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,
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.
Time frame: baseline to 12 weeks
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.
Time frame: from baseline to 4 weeks
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.
Time frame: from baseline to 8 weeks
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).
Time frame: from baseline to 4 weeks
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
Time frame: baseline to 8 weeks
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
Time frame: baseline to 12weeks
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.
Time frame: baseline to 4 weeks
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.
Time frame: baseline to 8 weeks
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).
Time frame: baseline to 12weeks
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
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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Plan to share: Undecided
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