CRPS-Hand: Contrast + Compression vs Whirlpool

NCT07744269 | Recruiting

• 1 other identifier: AESH-EK-2026-063
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complex Regional Pain Syndrome I (CRPS I)

Keywords

Contrast Therapy; Intermittent Pneumatic Compression; Whirlpool Therapy; Complex Regional Pain Syndrome; Hand Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  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).

Secondary Outcomes (6)

• 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)

Study Arms (2)

Combined Contrast Therapy with Intermittent Compression

EXPERIMENTAL

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.

Device: Combined Contrast Therapy with Intermittent Compression

Whirlpool Therapy

ACTIVE COMPARATOR

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.

Device: Whirlpool Therapy

Interventions

Combined Contrast Therapy with Intermittent Compression DEVICE

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

Also known as: Game Ready System, Cold and Compression Therapy

Combined Contrast Therapy with Intermittent Compression

Whirlpool Therapy DEVICE

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.

Also known as: Hydrotherapy, Technomex Whirlpool Device

Whirlpool Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital, Department of Physical Medicine and Rehabilitation

Ankara, Yenimahalle, 06370, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Gizem Suna Tuncer, MD, Specialist Physician

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gizem Suna Tuncer, MD, Specialist Physician

CONTACT

+905347953185; sunagizem05@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physical Medicine and Rehabilitation Specialist

Model Details: Parallel assignment: Participants will be randomly allocated into two groups, with one group receiving whirlpool therapy and the other receiving combined contrast therapy with intermittent compression, both administered over the same treatment duration.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: August 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)