Stellate Ganglion Block in Complex Regional Pain Syndrome

NCT07129811 | Recruiting DMC

• 2 other identifiers: TABED 1-24-804Ankara Bilkent City Hospital
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stellate Ganglion Block

Keywords

Stroke; chronic pain; Complex regional pain syndrome

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  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.

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

Secondary Outcomes (3)

• Brunnstroom stages of stroke recovery (BSSR)

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

• Fugl-Meyer Upper Extremity (FMUE) Scale

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

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

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

Study Arms (2)

Stellat Group

ACTIVE COMPARATOR

In group 1, stellate ganglion blockade will be applied in addition to conventional physical therapy.

Procedure: Stellate Ganglion Block

Only Physical Therapy Group

NO INTERVENTION

Group 2 will receive only conventional physical therapy and exercise therapy

Interventions

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.

Stellat Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Yoo SD, Jung SS, Kim HS, Yun DH, Kim DH, Chon J, Hong DW. Efficacy of ultrasonography guided stellate ganglion blockade in the stroke patients with complex regional pain syndrome. Ann Rehabil Med. 2012 Oct;36(5):633-9. doi: 10.5535/arm.2012.36.5.633. Epub 2012 Oct 31.

  PMID: 23185727 BACKGROUND

• Narouze S. Ultrasound-guided stellate ganglion block: safety and efficacy. Curr Pain Headache Rep. 2014 Jun;18(6):424. doi: 10.1007/s11916-014-0424-5.

  PMID: 24760493 BACKGROUND

• Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.

  PMID: 35687369 BACKGROUND

• Altas EU, Onat SS, Konak HE, Polat CS. Post-stroke complex regional pain syndrome and related factors: Experiences from a tertiary rehabilitation center. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):104995. doi: 10.1016/j.jstrokecerebrovasdis.2020.104995. Epub 2020 Jul 3.

  PMID: 32807418 BACKGROUND

MeSH Terms

Conditions

Stroke; Chronic Pain; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Seher KALIÇ MD

CONTACT

+905393628565; seherkalic@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher conducting the evaluations will not know the group the patient will be assigned to. The other researcher will determine which group the patient will be assigned to through randomization and will perform the intervention if the patient is in the stellate ganglion group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: January 15, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

TU (1)