The Effect of Extracorporeal Shock Wave Therapy on Range of Motion, Pain, Dexterity, and Function After Hand Flexor Tendon Injury.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
In this study aims to investigate the effects of extracorporeal shock wave therapy, applied to the intervention group in addition to the rehabilitation program applied to the control and intervention groups, on range of motion, pain, grip strength, and dexterity after hand flexor tendon injury.
详细描述
The hand is a fundamental element in daily living activities, occupation, and social independence. Although different studies report varying figures for hand injuries, they constitute approximately 20% of injuries presenting to emergency departments. Soft tissue traumas account for a significant portion of these injuries. Due to the proximity of flexor tendons to the skin, the hand is frequently affected in hand injuries.
One of the agents used to accelerate healing and function in hand tendons after injury or surgery, and to reduce adhesion and contracture formation, is Extracorporeal Shock Wave Therapy (ESWT). ESWT treatment modalities have been tested in experimental animal studies. The idea behind the use of shock waves in the treatment of orthopedic diseases is to stimulate healing in tendons, surrounding tissues, and bones. The importance of shock wave therapy on soft tissues has increased over time.
It has been reported that ESWT significantly reduces deformity in Dupuytren's disease treatment. Brunelli et al. found that radial ESWT (3 bars, 12 Hz, 1400 pulses) applied in 4 sessions to a patient with pain, weakness in the middle and ring fingers, and flexion deformity due to Dupuytren's disease resulted in a significant reduction in hand deformities and improvement in daily living performance. Positive results of the use of ESWT in hand flexor tendon pathologies have been published. In their cadaver study examining the applicability of radial ESWT to the flexor tendon, Lutter et al. stated that ESWT application at different intensities can penetrate soft tissues and is a treatment option in different finger pathologies. Malliaropoulos et al. have found that radial ESWT is effective in reducing pain and improving functional recovery in trigger finger treatment. This study aims to investigate the effect of ESWT on range of motion, pain, grip strength, and dexterity after hand flexor tendon injury. 56 patients who presented with flexor tendon injury and consented to participate will be included in this study and divided into two groups. All patients will be enrolled in a hand rehabilitation program including early passive mobilization according to the Modified Duran Protocol. In addition, the intervention group will receive 2000 pulses of radial ESWT at 2 bar pressure and 10 Hz frequency, applied to the flexor tendon scar tissue in 4 sessions, using a sweeping method with gel applied between the patient's skin and the probe.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• . Volunteering
- •. Being 8-12 weeks post-operatively after flexor tendon repair
- •. Having undergone flexor tendon zone II-IV surgical repair
排除标准
- •. Infection
- •• . Open wound
- •. Pregnancy
- •. History of finger or wrist fracture
- •. Inflammatory rheumatic disease
- •. Malignant tumor mass
研究组 & 干预措施
control
In accordance with the Modified Duran Protocol, a hand rehabilitation program, including early passive mobilization, will be implemented for 4 weeks.
intervention
In addition to a hand rehabilitation program that includes early passive mobilization in accordance with the Modified Duran Protocol, ESWT will be applied.
干预措施: Ekstracorporeal Shock Wave Therapy (Device)
结局指标
主要结局
Visual Analog Scale
时间窗: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
For VAS assessment, patients are informed about the meaning of the numbers placed on a 10 cm line from 0 to 10. It is explained that no pain is worth 0 points, moderate pain is worth 5 points, and the most severe pain felt is worth 10 points. Based on these explanations, the patient is asked to mark the pain on the 10 cm line. The distance between the marked point and the starting point is measured with a ruler to determine the pain intensity.
Range of Motion
时间窗: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
Range of motion (ROM) is one of the most frequently used outcome variables after tendon injuries in the hand. ROM measurement in the hand is performed using a finger goniometer. In active ROM assessment for the fingers, the patient is asked to make a fist for flexion and extend the finger straight; that is, the measurement is performed in a compound manner. In this study, the Modified Strickland calculation will be used for fingers 2-5. Active distal interphalangeal (DIF) and proximal interphalangeal (PIF) joint flexion are added together, and the active extension loss is subtracted. 175° is considered ideal and compared to 175°. The results are; 75°-100° is considered excellent, 50°-74° good, 25°-49° average, and 0°-24° poor.
Visual Analog Scale
时间窗: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
For VAS assessment, patients are informed about the meaning of the numbers placed on a 10 cm line from 0 to 10. It is explained that no pain is worth 0 points, moderate pain is worth 5 points, and the most severe pain felt is worth 10 points. Based on these explanations, the patient is asked to mark the pain on the 10 cm line. The distance between the marked point and the starting point is measured with a ruler to determine the pain intensity.
Range of Motion
时间窗: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
Range of motion (ROM) is one of the most frequently used outcome variables after tendon injuries in the hand. ROM measurement in the hand is performed using a finger goniometer. In active ROM assessment for the fingers, the patient is asked to make a fist for flexion and extend the finger straight; that is, the measurement is performed in a compound manner. In this study, the Modified Strickland calculation will be used for fingers 2-5. Active distal interphalangeal (DIF) and proximal interphalangeal (PIF) joint flexion are added together, and the active extension loss is subtracted. 175° is considered ideal and compared to 175°. The results are; 75°-100° is considered excellent, 50°-74° good, 25°-49° average, and 0°-24° poor.
次要结局
- Nine-hole peg test(Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.)
- Duruoz Hand Index(Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.)
- Short Form-36 Questionnaire(Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.)
- Nine-hole peg test(Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.)
- Duruoz Hand Index(Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.)
- Short Form-36 Questionnaire(Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.)
研究者
Nazife Kapan
Asist.Prof.
Kirsehir Ahi Evran Universitesi