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NCT Number: NCT07129811

Stellate Ganglion Block in Complex Regional Pain Syndrome

The aim was to investigate the effect of Stellate Ganglion Blockade, which will be applied in addition to conventional physical therapy, on pain and functionality in patients with poststroke complex regional pain syndrome.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hüma BÖLÜK ŞENLİKCİ Assoc Prof

CONTACT

[email protected]

+905370630777

About this study

Post-stroke complex regional pain syndrome (CRPS) is relatively common in hemiplegic upper extremity. Complex regional Pain Syndrome Type 1 is often seen without any nerve damage especially post-stroke. This musculoskeletal disorder usually effects motor improvement, quality of life and Daily living activities. Besides Presence of CRPS is thought to be challenging on the way of rehabilitation process. However, disproportionate sympthatic nervous system activation, disinhibition of the descenden neuronal pathways are the mechanisms thought to be taken place in the etiopathogenesis of CRPS, it still remains unclear. Pharmacological agents, Physical Therapy techniques, exercise and injections are used to treat CRPS. Therefore post-stroke patients have co-morbidities and multi-drug usage, it should be take into account to treat them with physical therapy agents and interventional procedures. Stellat ganglion blockade is an interventional technique that is used to break the vicious circle of symphatetic activation of upper extremity in CRPS. However to the best of our knowledge there are not any study that evaluates the effect of stellat ganglion Blockade on CPRS combining conventional physical therapy. Total of 32 patients with post-stroke CPRS are going to be participated in the study. Patients are going to be divided into two groups. Group 1 is going to receive both onventional physical therapy, exercise (10 sessions) and stellat ganglion blockade and Group 2 is going to receive just conventional physical therapy program and exercise therapy (10 sessions). Participants are going to evaluate before treatment, 2 weeks and 12 weeks after the end of the therapy sessions. Visual analog scale (VAS), Brunnstroom stages of stroke recovery (BSSR), Fugl-meyer (FMUE) and Stroke spesific quality of life (SSQoL) are used to evaluate pain, functionality and quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Volunteer male and female patients aged 18-75
  • Diagnosed with Complex Regional Pain Syndrome according to the IASP 2012 Diagnostic Criteria
  • Patient's pain level must be VAS >4

Exclusion criteria

  • Presence of existing neurological diseases other than rheumatic diseases and stroke
  • General impairment
  • Conditions that would constitute a contraindication to application, such as an open wound or sensory deficit in the application area
  • Presence of active infection
  • Presence of malignancy
  • Cognitive dysfunction (mini mental test result <23)

Treatment and study plan

Stellate ganglion block

Procedure

The stellate ganglion is located in front of the anterior tubercle of the C6 vertebra. An ultrasound-guided intervention will be performed from the affected side and 2 cc of 1% lidocaine will be injected.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Before treatment, 2 weeks and 12 weeks after the end of sessions

    Ten-cm VAS was used as a self-report measure for lower back pain intensity. Self reported pain measurement score is between 0-10 and higher scores indicates higher pain severity.

Secondary outcomes

  1. Brunnstroom stages of stroke recovery (BSSR)

    Time frame: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions

    The BSSR is used to evaluate the motor development of the hemiplegic upper extremity, lower extremity and hand in stroke patients using a staging system from 1 (flask) to 6 (normal motor function).

  2. Fugl-Meyer Upper Extremity (FMUE) Scale

    Time frame: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions

    The FMUE scale is a stroke- specific, performance-based measure of sensory motor impairment consisting of 33 items, each scored on a scale of 0 to 2. Higher scores signify a lower level of impairment.

  3. Stroke Specific Quality of Life scale (SS-QOL).

    Time frame: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions

    The SS-QOL is a questionnaire used to evaluate independence in ADL in patients with stroke, social role within the family and community and quality of life (QOL). It consists of 49 questions scored between one and five giving a total score between 49 and 245. Higher scores indicate better QOL.

Study contacts

Contact information is provided by the study sponsor or research team.

Seher KALIÇ MD

CONTACT

[email protected]

+905393628565

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effect of Ultrasound-Guided Stellate Ganglion Block on Pain, Functionality, and Quality of Life in Type 1 Complex Regional Pain Syndrome in Stroke Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Sep 5, 2025

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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