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临床试验/NCT06769373
NCT06769373招募中不适用

The Effects of Whirlpool Bath and Contrast Bath Treatments on Pain, Disability, Functionality and Grip Strength in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture

Afyonkarahisar Health Sciences University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Range of Motion Measurement

研究概览

简要总结

The aim of our study is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients with complex regional pain syndrome after distal radius fracture.

详细描述

Distal radius fractures are the most common fracture type among all body bone fractures. Fractures generally occur in elderly patients caused by low-energy trauma due to decreased bone quality. In young patients, they mostly occur due to traumas such as traffic accidents, falls from heights and sports injuries.

One of the important complications seen after distal radius fractures is complex regional pain syndrome (CRPS). Complex regional pain syndrome represents a complication following distal radius fractures that is still not fully understood etiologically.

Studies have shown that complex regional pain syndrome is commonly diagnosed among patients recovering from a fracture of the distal radius with a reported incidence as high as 37%. It is characterized by excessive pain (allodynia and/or hyperalgesia), edema, local blood flow changes and abnormality of the sudomotor nerve.

There are hardly any studies with a sufficient evidence level to make recommendations for treatments for CRPS-1; therefore, treatment is based on symptom management. Prevention of CRPS-1, after a distal radius fracture is important as this syndrome might lead to chronic pain and serious disabilities. In several studies, it was shown that CRPS-1 can be cured with exercise and graded activities. The main goals of physiotherapy are to reduce pain, regain range of motion, and increase muscle strength and function.

Whirlpool bath and contrast bath treatments are physical therapy methods that has been used safely in complex regional pain syndrome treatment for many years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

Double-Blinded Prospective Randomized Trial

入排标准

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

入选标准

  • •Patients with complex regional pain syndrome type-1 (CRPS-type 1) after distal radius fracture, who were followed conservatively (long/short arm splint-cast) between the ages of 18-70, who applied to AFSU Physical Medicine and Rehabilitation Clinic. It is planned to use the Budapest diagnostic criteria for the diagnosis of CRPS Type 1.

排除标准

  • •Orthopedic injuries (other accompanying orthopedic fractures, such as ulna fracture, carpal bone fractures),
  • •Other system injuries,
  • •Patients whose distal radius fractures were surgically treated,
  • •Patients who had previously undergone surgery on the same upper extremity,
  • •Nerve, tendon and artery injuries accompanying the fracture,
  • •Other neurological, orthopedic or rheumatological problems affecting the same upper extremity,
  • •Serious cardiovascular disease,
  • •Presence of active infection, active dermatitis, skin diseases such as pemphigus, febrile diseases,
  • •Presence of a fixed catheter in the area,
  • •Impaired temperature sensationin in the area.

研究组 & 干预措施

Whirlpool Bath Protocol

Experimental

An exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, whirlpool bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks.

干预措施: Whirlpool Bath (Device)

Contrast Bath Protocol

Experimental

An exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, contrasth bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks.

干预措施: Contrast Bath (Device)

结局指标

主要结局

Range of Motion Measurement

时间窗: up to 12th week

Supination and pronation of the forearm, flexion, extension, ulnar and radial deviation active/passive range of motion of the wrist will be evaluated with a universal goniometer. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.

Hand grip strength measurement with Jamar Dynamometer

时间窗: up to 12th week

Jamar Dynamometer measures isometric grip force and strength. Measurements will be made by sitting with the shoulder adducted and neutrally rotated, adjacent to the body, elbow flexed at 90 degrees, wrist dorsiflexed at 0-30 degrees and ulnar deviation at 0-15 degrees with the thumb pointing up. Measurements will be repeated three times, 5 seconds apart, on the hand on the affected side, and the average of the three measurements will be recorded in kilograms. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.

次要结局

  • Jebsen Taylor Hand Function Test(up to 12th week)
  • The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH)(up to 12th week)
  • Patient-rated Wrist Evaluation Form(up to 12th week)
  • Short Form 36 (SF-36)(up to 12th week)
  • Visual Analog Scale (VAS)(Up to 12th week)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu Keskin

Research Assistant Doctor

Afyonkarahisar Health Sciences University

研究点 (1)

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