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临床试验/NCT07207460
NCT07207460已完成不适用

Comparison of Hydrodissection Techniques Using 5% Dextrose for the Treatment of Carpal Tunnel Syndrome

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Boston CTS

研究概览

简要总结

The aim of this study was to compare the effectiveness of perineural hydrodissection methods performed with 5 mL D5W solution and three different injection techniques [ultrasound-guided in-plane, ultrasound-guided out-of-plane, and blind technique] in cases diagnosed with mild to moderate CTS by EMG.

详细描述

Carpal tunnel syndrome (CTS) is a highly prevalent condition in the general population, markedly impairing daily activities and sleep quality. Depending on disease severity and symptom burden, treatment approaches are broadly categorized as conservative or surgical. Beyond lifestyle modifications, numerous conservative interventions-including splinting, extracorporeal shock wave therapy, therapeutic ultrasound, phonophoresis, hydrodissection, kinesiotaping, corticosteroid (CS) injections, low-level laser therapy, platelet-rich plasma (PRP) injections, manual therapy, and acupuncture-have demonstrated clinical efficacy. More recently, 5% dextrose injections have emerged as a safe alternative to CS with minimal adverse effects. Injection therapies vary in both content and technique; however, no consensus exists regarding the optimal approach. Given the importance of minimizing side effects and ensuring long-term effectiveness, the refinement of injection agents and techniques remains a priority. Although ultrasound-guided injections improve safety and accuracy, they require expertise and incur additional costs, whereas blind techniques have long been applied reliably in clinical practice. Nevertheless, comparative studies evaluating these techniques remain limited. Therefore, the present study aimed to compare three different injection techniques for the management of CTS.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The study was conducted by four independent researchers. One investigator confirmed the CTS diagnosis using EMG and performed all follow-up EMG assessments. A second investigator measured the CSA using ultrasound. A third investigator performed all injections, while a fourth investigator was responsible for clinical evaluations and statistical analyses

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 20-70
  • Moderate and mild CTS patients diagnosed with CTS by EMG
  • Literate patients who agreed to participate in the study

排除标准

  • Patients with RA, type 1 or type 2 diabetes mellitus
  • Patients with chronic renal failure
  • Polyneuropathy
  • Those with a history of cancer, those receiving chemotherapy
  • Those with a history of broken hand wrist fracture in the last 6 months
  • Patients with brachial plexopathy or thoracic outlet syndrome (TOS)
  • Patients who underwent surgery due to CTS
  • Pregnancy
  • Hypothyroidism in a mixed edema picture
  • Diagnosed with neuromuscular disease
  • Patients with bleeding disorders or those currently receiving anticoagulant therapy
  • patients with infection at the injection site

结局指标

主要结局

Boston CTS

时间窗: 0 , 2nd week 12th week

The BCTQ is the most widely used measure for CTS. It includes 2 subscales with 11 questions assessing symptom severity and 8 questions assessing functional status.31 Scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.The BCTQ provides a standardized, patient-based outcome measure of symptom severity and functional status to assess the results of carpal tunnel syndrome treatments. The test has strong evidence of validity, reliability and responsiveness.

VAS

时间窗: 0 2nd week 12th week

VAS was used to assess digital pain intensity and paresthesia/dysthesia before injection therapy administration. Scores ranged from 10 (extremely severe pain) to 0 (no pain).

DN-4

时间窗: 0 2nd week 12th week

It is a clinical screening tool used to diagnose the presence of neuropathic pain.It was developed by the French Neuropathic Pain Group to address the difficulties and lack of consensus in diagnosing neuropathic pain.It is a questionnaire consisting of 10 items administered by the clinician.Seven pain-related items (i.e., sensory and pain descriptors) are administered in consultation with the patient. They express how pain is felt by the patient.The three items are based on clinical examination. The clinician assesses whether sensation to touch or pinprick is diminished (hyposthesia) and whether it increases with light brushing or causes pain (allodynia).

次要结局

  • Nerve CSA(0 2nd 12th week)
  • EMG(0 and 12th week)

研究者

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

Berna Orhan

Physical Therapy and Rehabilitation Specialist

Ankara City Hospital Bilkent

研究点 (1)

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