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Stellate Ganglion Block in Complex Regional Pain Syndrome

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07129811
Enrollment
32
Registered
2025-08-19
Start date
2025-01-15
Completion date
2025-10-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stellate Ganglion Block

Keywords

Stroke, chronic pain, Complex regional pain syndrome

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.

Detailed description

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.

Interventions

PROCEDUREStellate Ganglion Block

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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS)Before treatment, 2 weeks and 12 weeks after the end of sessionsTen-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

MeasureTime frameDescription
Brunnstroom stages of stroke recovery (BSSR)before treatment, 2 weeks and 12 weeks after the end of the therapy sessionsThe 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).
Fugl-Meyer Upper Extremity (FMUE) Scalebefore treatment, 2 weeks and 12 weeks after the end of the therapy sessionsThe 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.
Stroke Specific Quality of Life scale (SS-QOL).before treatment, 2 weeks and 12 weeks after the end of the therapy sessionsThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSeher KALIÇ MD
seherkalic@icloud.com+905393628565

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026