Complex Regional Pain Syndrome I (CRPS I)NCT07744269
CRPS-Hand: Contrast + Compression vs Whirlpool
A study testing Combined Contrast Therapy with Intermittent Compression and Whirlpool Therapy in people with Complex Regional Pain Syndrome I (CRPS I), run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndrome I (CRPS I)
- What is being tested?
- Combined Contrast Therapy with Intermittent Compression and Whirlpool Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital, Department of Physical Medicine and Rehabilitation
Ankara, Yenimahalle, 06370
Gizem Suna Tuncer, M.D, +905347953185, sunagizem05@gmail.com
About this study
Official title: Combined Contrast Therapy and Intermittent Compression vs Whirlpool Therapy in Post-Traumatic Hand and Wrist CRPS: A Randomized Controlled 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.
Read the detailed description
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.
- Being tested
- Combined Contrast Therapy with Intermittent Compression, Whirlpool Therapy
- Keywords
- Contrast Therapy, Intermittent Pneumatic Compression, Whirlpool Therapy, Complex Regional Pain Syndrome, Hand Rehabilitation
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Contrast Therapy with Intermittent CompressionDevice
Also called Game Ready System, Cold and Compression Therapy
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
Whirlpool TherapyDevice
Also called Hydrotherapy, Technomex Whirlpool 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Whirlpool Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Patients rate their pain on a 0-10 scale. A lower score indicates reduced pain.
Measured: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).
Secondary outcomes (6)
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.
Measured: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).
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.
Measured: at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
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.
Measured: 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)
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.
Measured: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Hand Grip Strength (HGS)
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).
Measured: at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Finger-to-Palm Crease Distance (FT-PCD)
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.
Measured: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 May 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome I (CRPS I)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gizem Suna Tuncer, Ankara Etlik City Hospital
- Investigators
- Gizem Suna Tuncer, MD, Specialist Physician, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744269
- Sponsor's protocol ID
- AESH-EK-2026-063
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Contrast Therapy and Intermittent Compression vs Whirlpool Therapy in Post-Traumatic Hand and Wrist CRPS: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07744269
- Acronym / sponsor ID
- AESH-EK-2026-063
- Keywords
- Contrast Therapy, Intermittent Pneumatic Compression, Whirlpool Therapy, Complex Regional Pain Syndrome, Hand Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined Contrast Therapy with Intermittent Compression | Experimental | Device: Combined Contrast Therapy with Intermittent CompressionParticipants 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. |
| Whirlpool Therapy | Active comparator | Device: Whirlpool TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Contrast Therapy with Intermittent CompressionAlso: Game Ready System, Cold and Compression TherapyThis 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 | Device | Combined Contrast Therapy with Intermittent Compression |
| Whirlpool TherapyAlso: Hydrotherapy, Technomex Whirlpool 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. | Device | Whirlpool Therapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 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.
6 secondary outcomes
Hand Function (QuickDASH)
Time frame: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).
Neuropathic Pain Assessment (LANSS)
Time frame: at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Edema Measurement (Circumferential Measurement)
Time frame: 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)
Time frame: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Hand Grip Strength (HGS)
Time frame: at baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Finger-to-Palm Crease Distance (FT-PCD)
Time frame: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gizem Suna Tuncer, MD, Specialist Physician principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Contrast Therapy with Intermittent Compression and Whirlpool Therapy in people with Complex Regional Pain Syndrome I (CRPS I), run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem Suna Tuncer, MD, Specialist Physician (+905347953185, sunagizem05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: At baseline, at 3 weeks (end of treatment), and at 7 weeks (follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.