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Completed

NCT Number: NCT07537465

Mirror Therapy for Complex Regional Pain Syndrome in Stroke Patients

The goal of this clinical study is to evaluate the effectiveness of mirror therapy in treating complex regional pain syndrome (CRPS) in patients after stroke using clinical assessments, electrophysiological evaluations, and ultrasonographic measurements by comparing pre- and post-treatment outcomes.

The main questions it aims to answer are:

Does mirror therapy lead to improvements in clinical outcomes in post-stroke patients with CRPS when assessed before and after treatment? Does mirror therapy reduce pain, improve motor function, and enhance functional independence based on clinical assessments? Does mirror therapy reduce swelling (edema) in the affected limb as measured by ultrasonographic evaluations? Does mirror therapy lead to changes in sympathetic nervous system function as assessed by electrophysiological evaluations?

Researchers will compare mirror therapy to sham mirror therapy (a similar procedure without therapeutic effect) to determine its effectiveness.

Participants will:

Be randomly assigned to either a mirror therapy group or a control group Receive conventional rehabilitation therapy and contrast bath treatment for 4 weeks Receive either mirror therapy or sham mirror therapy for 20 minutes daily Be evaluated before and after treatment using clinical scales, electrophysiological tests, and ultrasonographic measurements.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam&Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

Complex regional pain syndrome (CRPS) is a challenging complication following stroke, characterized by pain, edema, autonomic dysfunction, and impaired motor function. It significantly affects rehabilitation outcomes and quality of life. Despite various treatment approaches, optimal management remains difficult. Mirror therapy has emerged as a non-invasive rehabilitation technique that provides visual feedback and may influence cortical reorganization and pain modulation. Additionally, it may have effects on autonomic function, particularly the sympathetic nervous system.

This prospective, randomized, single-blind study was conducted in the inpatient Physical Medicine and Rehabilitation clinic of Başakşehir Çam and Sakura City Hospital between October 2022 and October 2023. Patients with post-stroke CRPS who met the inclusion criteria were enrolled and randomly assigned to either a mirror therapy group or a control group. Both groups received a standardized conventional rehabilitation program and contrast bath therapy. The intervention group additionally received mirror therapy, while the control group received sham mirror therapy.

The aim of the study was to evaluate the clinical effectiveness of mirror therapy in post-stroke CRPS through a multidimensional approach. Clinical status, functional outcomes, electrophysiological parameters related to sympathetic nervous system function, and ultrasonographic measurements of soft tissue changes were assessed before and after the intervention period.

This study provides comprehensive evaluation of mirror therapy effects by combining clinical assessments with objective electrophysiological and imaging-based measurements. The findings are expected to contribute to the understanding of the role of mirror therapy in the management of CRPS after stroke and to support its use as an accessible and complementary rehabilitation approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a first-ever ischemic or hemorrhagic stroke
  • Time since stroke onset of ≤ 12 months
  • Diagnosed with Complex Regional Pain Syndrome (CRPS) Type 1 according to the Budapest criteria
  • In the dystrophic stage (Stage 2) of CRPS
  • Mini-Mental State Examination (MMSE) score > 24
  • Brunnstrom upper extremity-hand stage between 1 and 4
  • Age between 18 and 65 years

Exclusion criteria

  • Unstable medical condition
  • Presence of neglect
  • Severe aphasia preventing completion of assessment scales
  • Presence of a concomitant lower motor neuron lesion
  • History of fracture, surgery, or amputation in the affected limb
  • Presence of implanted electronic devices (e.g., cardiac pacemaker)
  • Local infection at the application site
  • Use of oral steroids or pregabalin/gabapentin within the last 3 months
  • History of intra-articular injection, botulinum toxin injection, or suprascapular nerve block within the last 3 months

Treatment and study plan

Mirror Therapy

Behavioral

Mirror therapy was applied for 20 minutes daily for 4 weeks in addition to a conventional rehabilitation program and contrast bath therapy. Patients performed movements of the unaffected upper limb while watching its reflection in a mirror positioned in the mid-sagittal plane, creating the illusion of movement in the affected limb.

Sham Mirror Therapy

Behavioral

Sham mirror therapy was applied for 20 minutes daily for 4 weeks in addition to a conventional rehabilitation program and contrast bath therapy. The non-reflective side of the mirror was used so that no visual feedback of the affected limb was provided, and patients performed similar movements without the mirror illusion.

Primary outcomes

  1. Change in pain intensity (Visual Analog Scale - VAS)

    Time frame: Baseline and after 4 weeks

    Pain intensity will be assessed using the Visual Analog Scale (VAS) before and after the 4-week treatment period.

Secondary outcomes

  1. Change in motor recovery (Brunnstrom Staging)

    Time frame: Baseline and after 4 weeks

    Motor recovery will be assessed using Brunnstrom Staging before and after treatment.

  2. Change in upper extremity motor function (Fugl-Meyer Assessment)

    Time frame: Baseline and after 4 weeks

    Upper extremity motor function will be evaluated using the Fugl-Meyer Assessment before and after treatment.

  3. Change in spasticity (Modified Ashworth Scale, MAS)

    Time frame: Baseline and after 4 weeks

    Spasticity will be assessed using the Modified Ashworth Scale before and after treatment.

  4. Change in functional independence (Functional Independence Measure, FIM)

    Time frame: Baseline and after 4 weeks

    Functional independence will be assessed using the Functional Independence Measure before and after treatment.

  5. Change in neuropathic pain (DN4)

    Time frame: Baseline and after 4 weeks

    Neuropathic pain will be evaluated using the DN4 questionnaire before and after treatment.

  6. Change in neuropathic pain (LANSS)

    Time frame: Baseline and after 4 weeks

    Neuropathic pain will be evaluated using the LANSS scale before and after treatment.

  7. Change in sympathetic nervous system function (sympathetic skin response)

    Time frame: Baseline and after 4 weeks

    Sympathetic nervous system function will be evaluated using sympathetic skin response measurements before and after treatment.

  8. Change in cutaneous silent period (CSP)

    Time frame: Baseline and after 4 weeks

    Cutaneous silent period will be measured to evaluate electrophysiological changes before and after treatment.

  9. Change in subcutaneous tissue thickness (ultrasonography)

    Time frame: Baseline and after 4 weeks

    Subcutaneous tissue thickness will be measured using ultrasonography before and after treatment.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Efficacy of Mirror Therapy for Complex Regional Pain Syndrome in Post-Stroke Patients

Acronym: MT-CRPS-ST

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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