CRPS-Hand: Contrast + Compression vs Whirlpool

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 compres
• Устройство 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 compromis

Первичные конечные точки

• Visual Analog Scale (VAS) [Срок оценки: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).]

Вторичные конечные точки (6)

• Hand Function (QuickDASH) [Срок оценки: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).]
• Neuropathic Pain Assessment (LANSS) [Срок оценки: at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)]
• Edema Measurement (Circumferential Measurement) [Срок оценки: 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) [Срок оценки: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)]
• Hand Grip Strength (HGS) [Срок оценки: at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)]
• Finger-to-Palm Crease Distance (FT-PCD) [Срок оценки: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Etlik City Hospital, Department of Physical Medicine and Rehabilitation — Ankara

Идентификаторы

NCT: NCT07744269 · AESH-EK-2026-063

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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