Combined Contrast Therapy and Intermittent Compression vs Whirlpool Therapy in Post-Traumatic Hand and Wrist CRPS: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Hand Function (QuickDASH)(At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).)
- Neuropathic Pain Assessment (LANSS)(at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up))
- Edema Measurement (Circumferential Measurement)(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)(At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up))
- Hand Grip Strength (HGS)(at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up))
- Finger-to-Palm Crease Distance (FT-PCD)(At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up))
研究者
Gizem Suna Tuncer
Principal Investigator, Physical Medicine and Rehabilitation Specialist
Ankara Etlik City Hospital
