Contrast Compression Therapy for Post-Stroke Complex Regional Pain Syndrome

NCT07062913 | Completed

• 1 other identifier: E2-21-527
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.\*

Conditions

Stroke; Complex Regional Pain Syndrome; Hemiplegia

Keywords

Stroke; Complex Regional Pain Syndrome; Contrast Compression Therapy; Hemiplegia; Neurorehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity

  Upper extremity pain will be assessed at rest and during activity using the Visual Analog Scale.

  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.

  Baseline and after 4 weeks of treatment

Secondary Outcomes (4)

• Change in Clinical Motor Recovery

  Baseline and after 4 weeks of treatment

• Change in Neuropathic Pain Probability

  Baseline and after 4 weeks of treatment

• Change in Spasticity

  Baseline and after 4 weeks of treatment

• Change in Functional Independence

  Baseline and after 4 weeks of treatment

Study Arms (2)

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Procedure: Conventional Rehabilitation

Contrast Compression Therapy Group

EXPERIMENTAL

Device: Contrast Compression Therapy; Procedure: Conventional Rehabilitation

Interventions

Conventional Rehabilitation PROCEDURE

A standard rehabilitation program including positioning, range of motion exercises, stretching, strengthening, and conventional transcutaneous electrical nerve stimulation.

Conventional Rehabilitation Group

Contrast Compression Therapy DEVICE

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.

Contrast Compression Therapy Group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable medical condition
• Hemispatial neglect
• Sensory or motor aphasia
• Shoulder subluxation
• CRPS due to causes other than stroke
• Bilateral CRPS-I
• History of psychotic disorder
• Coexisting neuropathic pain syndromes (e.g., diabetic neuropathy)
• Presence of open wounds in the treatment area

Sponsors & Collaborators

• Meltem Gunes Akinci: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 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. 2025 Nov 19:1-10. doi: 10.1080/10749357.2025.2589193. Online ahead of print.

  PMID: 41261073 DERIVED

MeSH Terms

Conditions

Stroke; Complex Regional Pain Syndromes; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: November 1, 2021
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)