A Randomized Controlled Trial Comparing Active and Passive Motion Splint Immobilization for the Treatment of Extensor Tendon Injuries in Zones IV to VI of the Hand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Grip Strength of the Injured Hand
研究概览
简要总结
This study compares two methods of post-operative immobilization after surgical repair (tenorrhaphy) of extensor tendons in the fingers. Patients were randomly assigned to receive either a standard plaster splint or an alternative splinting method that allows controlled finger movement (ICAMS). The main goal was to determine which method leads to better recovery in terms of finger mobility, grip strength, pain, and patient comfort.
详细描述
Extensor tendon injuries of the hand are commonly treated with immobilization for 4-6 weeks using a plaster splint in the intrinsic plus position. However, prolonged immobilization may lead to tendon adhesions, joint stiffness, and delayed return to function. This randomized controlled clinical trial evaluated the efficacy of an immediate controlled active motion splinting protocol (ICAMS) compared to classic immobilization (CI) following extensor tendon tenorrhaphy in zones IV, V, and VI. Thirty patients were randomly assigned to either group. Functional outcomes were assessed at 4 and 6 weeks post-injury, including grip strength, joint range of motion, pain (VAS), Quick-DASH score, and patient satisfaction. The ICAMS group showed significantly better results in all main functional parameters. These findings support the use of early active motion protocols in selected cases of extensor tendon injury to enhance recovery and patient comfort.
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
This was a single-blind study. The outcomes assessor was blinded to group allocation. Participants and care providers were not blinded due to the visible nature of the splints.
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
- •Adults aged 18 years or older
- •Patients from the CHUVI Health Area
- •Diagnosed with an acute, single, complete extensor tendon laceration in zones IV, V, or VI of the long fingers
- •Treated with primary tenorrhaphy
- •Provided signed informed consent
- •Agreed to attend follow-up visits and comply with the study protocol
排除标准
- •More than one extensor tendon laceration in the same hand
- •Injuries involving the thumb
- •Tendon injuries with loss of substance
- •Associated injuries at the same level (e.g., bone fracture, nerve lesion)
- •Patients with cognitive impairment or inability to follow the protocol
- •Presence of other injuries or medical conditions that could interfere with assessment
研究组 & 干预措施
ICAMS Group
Participants received immediate controlled active motion splinting (ICAMS) after extensor tendon tenorrhaphy. The ICAMS protocol included a daytime yoke splint, which maintained the injured finger in 20° more extension than adjacent fingers, and a nocturnal intrinsic plus static splint. The protocol was maintained for 4 weeks post-surgery
干预措施: ICAMS Splinting Protocol (Device)
Classic Immobilization Group
Participants received standard immobilization with a plaster splint in the intrinsic plus position following extensor tendon tenorrhaphy. The immobilization was maintained continuously for 4 weeks.
干预措施: Classic Plaster Immobilization (Device)
结局指标
主要结局
Change in Grip Strength of the Injured Hand
时间窗: 4 and 6 weeks after injury
Grip strength was measured using a JAMAR manual dynamometer to evaluate functional recovery after extensor tendon tenorrhaphy. Measurements were taken at 4 and 6 weeks post-injury.
次要结局
- Change in MCP Joint Flexion(4 and 6 weeks after injury)
- Pain Intensity (VAS Score)(4 and 6 weeks after injury)
- Patient Satisfaction With Treatment Outcome(4 and 6 weeks after injury)
- Quick-DASH Score(4 and 6 weeks after injury)
- Patient Comfort With Immobilization(4 and 6 weeks after injury)