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NCT Number: NCT07839611

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

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.

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Key information

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

combined stellate ganglion block procedure and median nerve hydrodissection

Procedure

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 only

Procedure

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,

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 4 Weeks

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: baseline to 8 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

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

    Time frame: baseline to 12weeks

    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

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: baseline to 12weeks

    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).

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

    Time frame: 12 weeks

    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

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

    Time frame: 12 weeks

    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.

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

    Time frame: 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.

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

    Time frame: 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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