Combined Stellate Ganglion Block With Median Nerve Hydrodissection Versus Median Nerve Hydrodissection Only in Carpal Tunnel Syndrome: A Randomised Controlled Study
| Registry | NCT07839611 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Fayoum University (Other) |
| Conditions | Carpal Tunnel Syndrome (CTS) |
| Interventions | combined stellate ganglion block procedure and median nerve hydrodissection, Ultrasound-Guided Median Nerve Hydrodissection Procedure only (Procedure) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-08-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-09-24, last updated 2026-09-24 |
Related Papers Related Patents Related Grants Related Experts
All trials for Carpal Tunnel Syndrome (CTS) All trials of combined stellate ganglion block procedure and median nerve hydrodissection All trials of Ultrasound-Guided Median Nerve Hydrodissection Procedure only
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 .
| Arm | Type | Interventions | Description |
|---|---|---|---|
| combined stellate ganglion block with median nerve hydrodissection | Experimental | Procedure: combined stellate ganglion block procedure and median nerve hydrodissection | 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 |
| median nerve hydrodissection only | Active comparator | Procedure: Ultrasound-Guided Median Nerve Hydrodissection Procedure only | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria 1. Patients aged 18 years or older. 2. Patients diagnosed with carpal tunnel syndrome based on compatible clinical symptoms and signs. 3. Diagnosis confirmed by nerve conduction studies/electrodiagnostic testing. 4. Patients with mild to moderate carpal tunnel syndrome. 5. Patients with persistent symptoms despite conservative treatment. 6. Patients eligible for ultrasound-guided median nerve hydrodissection. 7. Patients willing to participate in the study and provide written informed consent. Exclusion Criteria 1. Previous surgical treatment for carpal tunnel syndrome in the affected hand. 2. Severe carpal tunnel syndrome with marked thenar muscle wasting or severe axonal loss. 3. Coexisting cervical radiculopathy or peripheral polyneuropathy. 4. Previous fracture, major trauma, or surgery involving the affected wrist or hand. 5. Other neurological or musculoskeletal conditions affecting the symptoms or functional assessment of the affected upper limb. 6. Local infection, inflammation, or skin lesion at the injection site. 7. Known bleeding disorder or contraindication to the injection procedure. 8. Current anticoagulant therapy that contraindicates the procedure. 9. Known allergy or contraindication to any medication used during the intervention.