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CRPS-Hand: Contrast + Compression vs Whirlpool

2026年8月1日 更新者：Gizem Suna Tuncer、Ankara Etlik City Hospital

Combined Contrast Therapy and Intermittent Compression vs Whirlpool Therapy in Post-Traumatic Hand and Wrist CRPS: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate and compare the effectiveness of combined contrast therapy with intermittent compression and whirlpool therapy in patients with post-traumatic CRPS-I of the hand and wrist, using objective outcome measures of pain, edema, and functional status.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Complex Regional Pain Syndrome Type 1 (CRPS-I) is a condition that may develop after upper extremity trauma, surgical interventions, or central nervous system disorders, leading to chronic pain and functional impairment. Hydrotherapy modalities such as whirlpool and contrast bath therapy are commonly used; however, comparative evidence with combined thermal and compression-based systems remains limited.

Combined contrast therapy with intermittent compression is a non-invasive intervention delivered using the Game Ready MED4 Elite device, which integrates thermal therapy (cold-warm) with intermittent pneumatic compression (IPC). Evidence, particularly from postoperative orthopedic settings, suggests that this approach may reduce pain and edema and promote functional recovery. Cryotherapy reduces inflammation and vascular permeability, thermotherapy promotes vasodilation and tissue relaxation, and intermittent pneumatic compression (IPC) enhances venous and lymphatic return, supporting regional circulation.

The whirlpool method is a commonly used adjunctive physical therapy modality in CRPS-I treatment, involving immersion of the affected extremity in circulating water at 38-40°C. This technique provides both thermal and mechanical stimulation, promoting regional circulation, reducing muscle spasm, and facilitating edema drainage. Additionally, the gentle massaging effect of water turbulence may contribute to pain modulation and tissue relaxation.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Gizem Suna Tuncer, MD, Specialist Physician
  • 电话号码：+905347953185
  • 邮箱：sunagizem05@gmail.com

学习地点

  • 土耳其（türkiye）
    • Yenimahalle
      • Ankara、Yenimahalle、土耳其（türkiye）、06370
        • 招聘中
        • Etlik City Hospital, Department of Physical Medicine and Rehabilitation
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients diagnosed with Complex Regional Pain Syndrome Type 1 (CRPS-I) according to the Budapest Criteria
  • Age between 18 and 80 years
  • CRPS developed following upper extremity trauma (e.g., hand or wrist fracture, soft tissue injury)
  • Symptom duration less than 3 months (subacute stage)
  • Ability and willingness to provide written informed consent and voluntarily participate in the study

Exclusion Criteria:

  • Patients diagnosed with Complex Regional Pain Syndrome Type 2 (CRPS-II) or with evidence of peripheral nerve injury
  • History of peripheral neuropathy, Raynaud's phenomenon, or vascular circulation disorders
  • Presence of impaired skin integrity, open wounds, infection, or dermatological disease in the affected area
  • History of cold or heat intolerance, cold urticaria, or hypersensitivity to thermal modalities
  • Active infection or severe edema in the affected extremity
  • Presence of serious systemic diseases (cardiovascular, pulmonary, renal, or neurological)
  • Receipt of similar physical therapy or modality-based treatment within the past 3 months

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Combined Contrast Therapy with Intermittent Compression
Participants in this group will receive combined contrast therapy with intermittent pneumatic compression in addition to a standardized exercise program. The intervention will be delivered over a 3-week period (5 sessions/week, 15 sessions in total). Combined contrast therapy will integrate alternating hot and cold thermal therapy with intermittent pneumatic compression. The standardized exercise program will include supervised range-of-motion, stretching, and upper extremity mobility exercises targeting the wrist and hand.
设备：Combined Contrast Therapy with Intermittent Compression

This non-invasive intervention will be delivered using the Game Ready MED4 Elite device, which integrates thermal therapy (hot-cold) with intermittent pneumatic compression (IPC). The device is capable of simultaneously providing contrast therapy and intermittent pneumatic compression and is widely used in upper and lower extremity rehabilitation.

Rapid Contrast Therapy Protocol:

Heat application: Applied at 39 °C for 3 minutes Cold application: Applied at 15 °C for 1 minute, with mild compression during the cold phase Cycle duration: The heat-cold cycle will be repeated continuously for a total of 15 minutes

其他名称：
  • Game Ready System
  • Cold and Compression Therapy
有源比较器：Whirlpool Therapy

Participants in this group will receive whirlpool therapy along with a standardized exercise program. The intervention will be administered over a 3-week period, 5 sessions per week, for a total of 15 sessions.

Whirlpool therapy will be applied by immersing the affected hand and wrist in circulating water maintained at 40 °C, providing both thermal and mechanical stimulation.

The standardized exercise program will include supervised range-of-motion, stretching, and upper extremity mobility exercises targeting the wrist and hand.
设备：Whirlpool Therapy

Whirlpool therapy is a hydrotherapy modality used to enhance circulation in the upper extremity, reduce muscle spasm, alleviate pain, and facilitate edema resolution. In this study, a Technomex® whirlpool device will be used for hydrotherapy applications. The water temperature will be set at 40 °C and continuously monitored with a thermometer.

The device motor will generate a circular turbulent water flow. The patient's hand and wrist will be positioned comfortably in the tank without compromising circulation.

The duration of each session will be 15 minutes.

其他名称：
  • 水疗
  • Technomex Whirlpool Device

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Visual Analog Scale (VAS)
大体时间：At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).
Patients rate their pain on a 0-10 scale. A lower score indicates reduced pain.
At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).

次要结果测量

结果测量
措施说明
大体时间
Hand Function (QuickDASH)
大体时间：At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire is a brief and practical tool used to assess upper extremity functional status and its impact on daily activities. It is the short form of the original DASH questionnaire and consists of 11 items. Participants rate their difficulty in performing daily activities involving the arm, shoulder, and hand using a 5-point Likert scale. Scores are standardized on a 0-100 scale, where 0 indicates no disability and 100 indicates the highest level of disability.
At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).
Neuropathic Pain Assessment (LANSS)
大体时间：at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Neuropathic pain will be evaluated using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. This tool assesses pain characteristics and sensory dysfunction through a combination of patient-reported symptoms and clinical examination findings. The total score ranges from 0 to 24, with scores ≥12 suggesting the presence of neuropathic pain.
at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Edema Measurement (Circumferential Measurement)
大体时间：at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Edema will be assessed using circumferential measurements with a measuring tape at the wrist and palm. Wrist circumference will be measured just proximal to the distal radioulnar joint, and palm circumference will be measured at the widest level across the metacarpal heads. Measurements will be performed with the patient in a relaxed sitting or standing position, with the hand and wrist in a neutral position and the limb supported to avoid muscle contraction. The tape will be applied gently without compression. Two to three measurements will be taken at each site, and the average value will be recorded.
at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Range of Motion (ROM) and Finger-to-Palm Crease Distance (FT-PCD)
大体时间：At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Wrist range of motion will be assessed by measuring wrist flexion and extension using a standard hand goniometer. The patient will be positioned in sitting with the shoulder in neutral position, the elbow at 90° flexion, the forearm in neutral rotation, and the wrist in a neutral position. Each movement will be measured 2-3 times, and the average value will be recorded.
At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Hand Grip Strength (HGS)
大体时间：at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Hand grip strength will be measured using a Jamar hand dynamometer (Jamar, USA) in accordance with the standardized position recommended by the American Society of Hand Therapists. Participants will be seated with the shoulder in adduction and neutral rotation, the elbow at 90° flexion, the forearm in neutral position, and the wrist in a neutral position. Three measurements will be performed for each participant with a 1-minute rest interval between trials, and the average value will be recorded. Grip strength will be expressed in kilograms-force (kgf).
at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Finger-to-Palm Crease Distance (FT-PCD)
大体时间：At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Finger-to-palm crease distance (FT-PCD) will be measured in centimeters as the distance between the tip of the third finger and the distal palmar crease. This measurement will be used to quantitatively assess limitations in finger flexion associated with edema and joint stiffness.
At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ankara Etlik City Hospital

调查人员

  • 首席研究员：Gizem Suna Tuncer, MD, Specialist Physician、Ankara Etlik City Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2027年4月30日

研究完成 (估计的)

2027年7月30日

研究注册日期

首次提交

2026年7月19日

首先提交符合 QC 标准的

2026年8月1日

首次发布 (实际的)

2026年8月4日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月1日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AESH-EK-2026-063

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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