CRPS-Hand: Contrast + Compression vs Whirlpool
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAnkara Etlik City Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Combined Contrast Therapy with Intermittent Compression
DeviceThis 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
Whirlpool Therapy
DeviceWhirlpool 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Combined Contrast Therapy with Intermittent CompressionExperimental treatment 1 intervention
Group B: Whirlpool TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS)
Patients rate their pain on a 0-10 scale. A lower score indicates reduced pain.
Time frame
At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).Secondary outcomes
1
Hand Function (QuickDASH)
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.
Time frame
At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).2
Neuropathic Pain Assessment (LANSS)
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.
Time frame
at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)3
Edema Measurement (Circumferential Measurement)
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.
Time frame
at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)4
Range of Motion (ROM) and Finger-to-Palm Crease Distance (FT-PCD)
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.
Time frame
At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)Sponsors and contacts
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Source ClinicalTrials.gov