StrokeNCT07062913
Contrast Compression Therapy for Post-Stroke Complex Regional Pain Syndrome
A study testing Conventional Rehabilitation and Contrast Compression Therapy in people with Stroke and Complex Regional Pain Syndrome, run by Meltem Gunes Akinci at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of contrast compression therapy as an adjunct to conventional rehabilitation in patients diagnosed with complex regional pain syndrome (CRPS) following stroke. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Stroke, Complex Regional Pain Syndrome, Hemiplegia
- What is being tested?
- Conventional Rehabilitation and Contrast Compression Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 9 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 25 and 80 years
- First-ever stroke diagnosed within the previous 12 months
- Diagnosis of upper-extremity complex regional pain syndrome type I (CRPS-I) according to the Budapest clinical criteria
- Subacute-stage CRPS affecting the upper limb
- Mini-Mental State Examination (MMSE) score greater than 23
- Provided written informed consent
Who cannot join
- Unstable medical condition
- Hemispatial neglect
- Sensory or motor aphasia
- Shoulder subluxation
- CRPS due to causes other than stroke
- Bilateral CRPS-I
Show all 9Show fewer
- History of psychotic disorder
- Coexisting neuropathic pain syndromes (e.g., diabetic neuropathy)
- Presence of open wounds in the treatment area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Contrast Compression Therapy for Post-Stroke Complex Regional Pain Syndrome: A Randomized Control Trial
This study aims to evaluate the effectiveness of contrast compression therapy as an adjunct to conventional rehabilitation in patients diagnosed with complex regional pain syndrome (CRPS) following stroke. Post-stroke CRPS, previously known as shoulder-hand syndrome, is a challenging condition that affects upper extremity function and quality of life. Although various conservative treatments such as medication, physical therapy, and contrast water therapy have been used with varying success, evidence for standardized protocols remains limited.
In this prospective, single-center, single-blind, randomized controlled trial, eligible patients with post-stroke CRPS type I were randomly assigned to receive either conventional rehabilitation alone or combined with contrast compression therapy. The intervention included 10 sessions of sequential thermal phases with pneumatic compression applied to the affected upper limb, delivered with a specialized device in addition to standard therapy.
The primary outcome measures were pain level and edema volume. Secondary outcomes included functional recovery, spasticity, clinical motor recovery, and neuropathic pain assessments. This study aims to contribute new evidence about whether contrast compression therapy offers additional benefits for managing post-stroke CRPS.*
Read the detailed description
Post-stroke complex regional pain syndrome (CRPS), also known as shoulder-hand syndrome, is observed in more than 50% of patients who have experienced a stroke. This condition is typically classified as Type I CRPS due to the absence of identifiable peripheral nerve injury. Although the precise underlying mechanism remains unclear, biomechanical factors that cause mechanical instability of the shoulder joint and repetitive microtrauma are considered major risk factors for its development.
Clinically, post-stroke CRPS is characterized by severe pain involving both the shoulder and wrist, accompanied by symptoms such as edema, warmth, redness, limited range of motion, tenderness in the metacarpophalangeal joints, and in later stages, joint contractures that may cause significant functional impairment. The chronic nature of CRPS can lead to substantial limitations in upper extremity use, prolonged hospital stays, dependency in daily living activities, and increased overall rehabilitation costs, thereby reducing patients' quality of life.
Although various conservative treatments-including pharmacological agents, physical therapy, contrast water therapy (CWT), and sympathetic nerve blocks-are frequently used, the effectiveness, long-term safety, and accessibility of standardized treatment protocols remain limited. Traditional contrast water therapy aims to stimulate circulation and modulate inflammation by alternating vasodilation and vasoconstriction phases; however, modern contrast compression therapy enhances this principle by combining sequential thermal stimulation with active pneumatic compression. This combination aims to improve not only peripheral circulation but also lymphatic drainage and tissue oxygenation.
Contrast compression therapy has gained popularity in recent years, especially in orthopedic and sports rehabilitation, due to its potential benefits in controlling pain and edema. Technological advancements have enabled these systems to deliver precisely regulated temperature, pressure, and treatment durations, allowing for a more controlled and personalized approach compared to conventional methods. Despite promising results in musculoskeletal applications, no clinical trial to date has specifically evaluated the effects of contrast compression therapy in the neurological rehabilitation context, particularly for patients with post-stroke CRPS.
Therefore, this randomized controlled trial was designed to investigate whether adding contrast compression therapy to conventional rehabilitation provides additional benefits for pain control, edema reduction, functional recovery, and motor improvement in patients diagnosed with post-stroke CRPS, aiming to address an important gap in the current literature.
- Conditions
- Stroke, Complex Regional Pain Syndrome, Hemiplegia
- Being tested
- Conventional Rehabilitation, Contrast Compression Therapy
- Keywords
- Stroke, Complex Regional Pain Syndrome, Contrast Compression Therapy, Hemiplegia, Neurorehabilitation
- Medical subject headings
- Stroke, Complex Regional Pain Syndromes, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RehabilitationProcedure or surgery
A standard rehabilitation program including positioning, range of motion exercises, stretching, strengthening, and conventional transcutaneous electrical nerve stimulation.
Contrast Compression TherapyDevice
Contrast compression therapy using a Game Ready® MED4 ELITE device applied to the affected upper extremity with sequential hot and cold phases and pneumatic compression.
Conventional RehabilitationProcedure or surgery
Same standard rehabilitation program as in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Not described Receives: Procedure: Conventional Rehabilitation |
| Contrast Compression Therapy Group | Experimental | Not described Receives: Device: Contrast Compression Therapy; Procedure: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Upper extremity pain will be assessed at rest and during activity using the Visual Analog Scale.
Measured: Baseline and after 4 weeks of treatment
Change in Upper Extremity Edema Volume
Edema will be measured by the water displacement method using a hand volumeter.
Measured: Baseline and after 4 weeks of treatment
Secondary outcomes (4)
Change in Clinical Motor Recovery
Motor recovery will be evaluated using the Brunnstrom Motor Recovery Stages for the upper extremity and hand.
Measured: Baseline and after 4 weeks of treatment
Change in Neuropathic Pain Probability
Neuropathic pain probability will be assessed using the painDETECT Questionnaire.
Measured: Baseline and after 4 weeks of treatment
Change in Spasticity
Spasticity will be measured using the Modified Ashworth Scale.
Measured: Baseline and after 4 weeks of treatment
Change in Functional Independence
Functional status will be assessed using the motor subscale of the Functional Independence Measure.
Measured: Baseline and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Nov 2021
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meltem Gunes Akinci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meltem Gunes Akinci, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062913
- Sponsor's protocol ID
- E2-21-527
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD due to patient confidentiality and ethical restrictions.
Publications
Akinci MG, Polat CS, Tombak Demircakan A, Bukun YZ, Dalyan M. Effectiveness of contrast compression therapy for post-stroke complex regional pain syndrome: a randomized control trial. Top Stroke Rehabil. 2026 Jul;33(5):566-575. doi: 10.1080/10749357.2025.2589193. Epub 2025 Nov 19.
PubMed 41261073
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Contrast Compression Therapy for Post-Stroke Complex Regional Pain Syndrome: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07062913
- Acronym / sponsor ID
- E2-21-527
- Conditions
- Stroke, Complex Regional Pain Syndrome, Hemiplegia
- Keywords
- Stroke, Complex Regional Pain Syndrome, Contrast Compression Therapy, Hemiplegia, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Meltem Gunes AkinciUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 14 Jul 2025 (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 study aims to evaluate the effectiveness of contrast compression therapy as an adjunct to conventional rehabilitation in patients diagnosed with complex regional pain syndrome (CRPS) following stroke. Post-stroke CRPS, previously known as shoulder-hand syndrome, is a challenging condition that affects upper extremity function and quality of life. Although various conservative treatments such as medication, physical therapy, and contrast water therapy have been used with varying success, evidence for standardized protocols remains limited.
In this prospective, single-center, single-blind, randomized controlled trial, eligible patients with post-stroke CRPS type I were randomly assigned to receive either conventional rehabilitation alone or combined with contrast compression therapy. The intervention included 10 sessions of sequential thermal phases with pneumatic compression applied to the affected upper limb, delivered with a specialized device in addition to standard therapy.
The primary outcome measures were pain level and edema volume. Secondary outcomes included functional recovery, spasticity, clinical motor recovery, and neuropathic pain assessments. This study aims to contribute new evidence about whether contrast compression therapy offers additional benefits for managing post-stroke CRPS.*
Detailed description
Post-stroke complex regional pain syndrome (CRPS), also known as shoulder-hand syndrome, is observed in more than 50% of patients who have experienced a stroke. This condition is typically classified as Type I CRPS due to the absence of identifiable peripheral nerve injury. Although the precise underlying mechanism remains unclear, biomechanical factors that cause mechanical instability of the shoulder joint and repetitive microtrauma are considered major risk factors for its development.
Clinically, post-stroke CRPS is characterized by severe pain involving both the shoulder and wrist, accompanied by symptoms such as edema, warmth, redness, limited range of motion, tenderness in the metacarpophalangeal joints, and in later stages, joint contractures that may cause significant functional impairment. The chronic nature of CRPS can lead to substantial limitations in upper extremity use, prolonged hospital stays, dependency in daily living activities, and increased overall rehabilitation costs, thereby reducing patients' quality of life.
Although various conservative treatments-including pharmacological agents, physical therapy, contrast water therapy (CWT), and sympathetic nerve blocks-are frequently used, the effectiveness, long-term safety, and accessibility of standardized treatment protocols remain limited. Traditional contrast water therapy aims to stimulate circulation and modulate inflammation by alternating vasodilation and vasoconstriction phases; however, modern contrast compression therapy enhances this principle by combining sequential thermal stimulation with active pneumatic compression. This combination aims to improve not only peripheral circulation but also lymphatic drainage and tissue oxygenation.
Contrast compression therapy has gained popularity in recent years, especially in orthopedic and sports rehabilitation, due to its potential benefits in controlling pain and edema. Technological advancements have enabled these systems to deliver precisely regulated temperature, pressure, and treatment durations, allowing for a more controlled and personalized approach compared to conventional methods. Despite promising results in musculoskeletal applications, no clinical trial to date has specifically evaluated the effects of contrast compression therapy in the neurological rehabilitation context, particularly for patients with post-stroke CRPS.
Therefore, this randomized controlled trial was designed to investigate whether adding contrast compression therapy to conventional rehabilitation provides additional benefits for pain control, edema reduction, functional recovery, and motor improvement in patients diagnosed with post-stroke CRPS, aiming to address an important gap in the current literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Procedure: Conventional Rehabilitation |
| Contrast Compression Therapy Group | Experimental | Device: Contrast Compression Therapy, Procedure: Conventional Rehabilitation |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 25 and 80 years
- First-ever stroke diagnosed within the previous 12 months
- Diagnosis of upper-extremity complex regional pain syndrome type I (CRPS-I) according to the Budapest clinical criteria
- Subacute-stage CRPS affecting the upper limb
- Mini-Mental State Examination (MMSE) score greater than 23
Key exclusion criteria (9 listed)
- Unstable medical condition
- Hemispatial neglect
- Sensory or motor aphasia
- Shoulder subluxation
- CRPS due to causes other than stroke
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 |
|---|---|---|
| Conventional RehabilitationA standard rehabilitation program including positioning, range of motion exercises, stretching, strengthening, and conventional transcutaneous electrical nerve stimulation. | Procedure or surgery | Conventional Rehabilitation Group |
| Contrast Compression TherapyContrast compression therapy using a Game Ready® MED4 ELITE device applied to the affected upper extremity with sequential hot and cold phases and pneumatic compression. | Device | Contrast Compression Therapy Group |
| Conventional RehabilitationSame standard rehabilitation program as in the control group. | Procedure or surgery | Contrast Compression Therapy Group |
Primary outcome
Change in Pain Intensity
Time frame: Baseline and after 4 weeks of treatment
Upper extremity pain will be assessed at rest and during activity using the Visual Analog Scale.
Change in Upper Extremity Edema Volume
Time frame: Baseline and after 4 weeks of treatment
Edema will be measured by the water displacement method using a hand volumeter.
4 secondary outcomes
Change in Clinical Motor Recovery
Time frame: Baseline and after 4 weeks of treatment
Change in Neuropathic Pain Probability
Time frame: Baseline and after 4 weeks of treatment
Change in Spasticity
Time frame: Baseline and after 4 weeks of treatment
Change in Functional Independence
Time frame: Baseline and after 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 41261073Akinci MG, Polat CS, Tombak Demircakan A, Bukun YZ, Dalyan M. Effectiveness of contrast compression therapy for post-stroke complex regional pain syndrome: a randomized control trial. Top Stroke Rehabil. 2026 Jul;33(5):566-575. doi: 10.1080/10749357.2025.2589193. Epub 2025 Nov 19.
- Individual participant dataSharing planned: No. There is no plan to share IPD due to patient confidentiality and ethical restrictions.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rehabilitation and Contrast Compression Therapy in people with Stroke and Complex Regional Pain Syndrome, run by Meltem Gunes Akinci 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 14 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline and after 4 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07062913, which also lists 1 linked publication.
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 14 Jul 2025.