Randomized Control Trial Comparing the Outcome of a Modified Mini-incision Approach Versus the Conventional Approach for Carpal Tunnel Release
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- improvement in carpal tunnel syndrome associated pain
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the commonest nerve compression syndrome in the upper limbs, and carpal tunnel decompression is one of the most prevalent upper limb surgical interventions. Surgeries for CTS may be more effective compared to conservative measures in reducing symptoms and improving hand function, particularly in patients with severe CTS.
The etiology of CTS is multifactorial and includes occupational and personal factors. Physical workload factors play an important role in CTS but the role of some personal factors is less clear. Obesity is a well-documented risk factor for CTS. Hypothyroidism, diabetes mellitus, rheumatoid arthritis and osteoarthritis are possible risk factors for CTS. Finally, the role of smoking in CTS is uncertain.
Traditional approach makes use of a longitudinal skin incision from the palm toward the wrist and across the transverse carpal ligament. Though this approach offers excellent visualization, reliable release of the full retinaculum, and ability to identify anatomic variations, it is associated with some intractable complications, including wound pain, scar tenderness, flexor tendon entrapment and thenar as well as hypothenar (pillar) pain, which are difficult to recovery.
The attempt to perform CTR without extra complications leads to the development of different techniques and several mini-incision approaches.
These techniques help to reduce incisional discomfort after surgery, but it can lead to frequent incidence of blood vessel injury or incomplete release. The mini-incision approaches have the advantage of leaving a smaller scar, less scar pain, and lower grade of pillar pain. Though several methods have been proposed, there were still some disadvantages in them. Though CTR can be safely accomplished by them, incomplete release still occurred in several cases for some reasons.
After intensive research in the current literature, there is a paucity of studies evaluating the efficacy and safety of mini-incision approaches in achieving CTR in Egyptian patients. That is why we conducted the present study to present our experience with the modified mini-incision technique and compare its outcomes to the conventional open approach.
详细描述
All selected cases with primary CTS will be submitted to:
I) Preoperative evaluation:
A- Careful history taking: Brief history based on the characteristics of pain, sensory disturbances including numbness, tingling, and/or weakness involving the median nerve distribution. Patients were additionally inquired about their functional status, normal activities, ability to work, family history of diabetes and the use of medications.
B- The visual analogue scale (VAS) (0= no pain to 10= worst possible pain), will be used to assess the severity of diabetic neuropathic pain.
C- Neurosensory examination mainly included percussion over a distribution of the affected peripheral nerve (Tinel sign) and two-point discrimination (2-PD) using the Disk-Criminator.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary CTS attending Mansoura university hospitals with EMG-and NCS-proved median neuropathy at the wrist.
- •Failed conservative treatment.
- •Absence of any other hand pathology.
- •Positive Tinel sign presented at the site of nerve entrapment (the carpal tunnel at the wrist for the median nerve).
- •Signed informed consent.
排除标准
- •Presence of proximal radiculopathy.
- •Previous history of cervical spondylosis.
- •Inflammatory joint disease and gout.
- •Presence of combined nerve compression.
- •Having a previous hand or upper extremity surgery.
- •Patients with incomplete follow-up data were also excluded from this study.
- •Psychiatric disease or any other condition that is at risk of being influenced by the study or that might have affected completion of the study.
- •Patient refusal
研究组 & 干预措施
mini incision group
Patients were subjected to a longitudinal mini-incision started just above the proximal flexor wrist crease and then extended for 1.5 - 2 cm in a proximal direction.
干预措施: carpal tunnel release mini-incision (Procedure)
mini incision group
Patients were subjected to a longitudinal mini-incision started just above the proximal flexor wrist crease and then extended for 1.5 - 2 cm in a proximal direction.
干预措施: carpal tunnel release conventional incision (Procedure)
conventional group
Patients were subjected a longitudinal incision which was created between the thenar and hypothenar eminences along the longitudinal axis of the ring finger. Then, it was extended to the proximal flexor wrist crease.
干预措施: carpal tunnel release mini-incision (Procedure)
conventional group
Patients were subjected a longitudinal incision which was created between the thenar and hypothenar eminences along the longitudinal axis of the ring finger. Then, it was extended to the proximal flexor wrist crease.
干预措施: carpal tunnel release conventional incision (Procedure)
结局指标
主要结局
improvement in carpal tunnel syndrome associated pain
时间窗: 6 months postoperative
According to visual analogue scale for pain which consists of 10 items , 0 for no pain and 10 for the maximum pain.
次要结局
- operative time(from start till the end of the operation)
- scar effect(from surgery till 3,6 months postoperative)
- recurrence of neuropathic symptoms(it will be evaluated till 6 months postoperative)
- pillar pain(1,3&6 months postoperative)
研究者
Mohamed Mostafa
consultant and lecturer of general surgery
Mansoura University