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临床试验/NCT07839611
NCT07839611尚未招募不适用

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

Fayoum University0 个研究点目标入组 80 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 12 Weeks

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

the study will be assessor-blinded: The proceduralist cannot be blinded. Participants will be informed they will receive one of two active interventions; however, full participant blinding is not feasible without sham SGB. Outcome assessors (BCTQ, VAS, clinical tests), electrophysiology personnel (ENMG/NCS), and the statistician will be blinded to allocation. Group labels will be coded (Group 1/Group 2) until analysis is completed.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

combined stellate ganglion block with median nerve hydrodissection

Experimental

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

干预措施: combined stellate ganglion block procedure and median nerve hydrodissection (Procedure)

median nerve hydrodissection only

Active Comparator

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.

干预措施: Ultrasound-Guided Median Nerve Hydrodissection Procedure only (Procedure)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 4 Weeks(from baseline to 4 weeks)
  • Change in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score from Baseline to 8 Weeks(from baseline to 8 weeks)
  • Change in Visual Analog Scale for Pain Score from Baseline to 4 Weeks(from baseline to 4 weeks)
  • Change in Visual Analog Scale (VAS) for Pain Score from Baseline to 8weeks(baseline to 8 weeks)
  • Change in Visual Analog Scale (VAS) for Pain Score from Baseline to 12 Weeks(baseline to 12weeks)
  • Change in Boston Carpal Tunnel Questionnaire Functional Status Scale Score from Baseline to 4 Weeks(baseline to 4 weeks)
  • Change in Boston Carpal Tunnel Questionnaire Functional Status Scale Score from Baseline to 8 Weeks(baseline to 8 weeks)
  • Change in Boston Carpal Tunnel Questionnaire Functional Status Scale Score from Baseline to 12 Weeks(baseline to 12weeks)
  • number of participants requiring additional intervention during the 12 weeks follow up(12 weeks)
  • Time to Recurrence of Carpal Tunnel Syndrome Symptoms During 12 Weeks Follow up(12 weeks)
  • Number of Participants with a Positive Phalen's Test at 12 Weeks(12 weeks)
  • Number of Participants with a Positive Tinel's Test at 12 Weeks(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeyad nabil Salah ahmed

resident,Department of anesthesia and surgical intensive care

Fayoum University

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