Stellate Ganglion Block in Complex Regional Pain Syndrome

NCT ID: NCT07129811

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Stellate Ganglion Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Stellat Group

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

Group Type ACTIVE_COMPARATOR

Stellate Ganglion Block

Intervention Type 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.

Only Physical Therapy Group

Group 2 will receive only conventional physical therapy and exercise therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stellate 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Seher KALIÇ

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Seher KALIÇ MD

Role: CONTACT

+905393628565

Facility Contacts

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Hüma BÖLÜK ŞENLİKCİ Assoc Prof

Role: primary

+905370630777

References

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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.

Reference Type BACKGROUND
PMID: 23185727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24760493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35687369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32807418 (View on PubMed)

Other Identifiers

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Ankara Bilkent City Hospital

Identifier Type: OTHER

Identifier Source: secondary_id

TABED 1-24-804

Identifier Type: -

Identifier Source: org_study_id

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