CRPS-Hand: Contrast + Compression vs Whirlpool
Combined Contrast Therapy and Intermittent Compression vs Whirlpool Therapy in Post-Traumatic Hand and Wrist CRPS: A Randomized Controlled Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Gizem Suna Tuncer, MD, Specialist Physician
- Número de telefone: +905347953185
- E-mail: sunagizem05@gmail.com
Locais de estudo
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turquia (Türkiye), 06370
- Recrutamento
- Etlik City Hospital, Department of Physical Medicine and Rehabilitation
-
Contato:
- Gizem Suna Tuncer, M.D
- Número de telefone: +905347953185
- E-mail: sunagizem05@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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
Outros nomes:
|
|
Comparador Ativo: 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. |
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Analog Scale (VAS)
Prazo: 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).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hand Function (QuickDASH)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gizem Suna Tuncer, MD, Specialist Physician, Ankara Etlik City Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AESH-EK-2026-063
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .