Stellate Ganglion Blockage in Complex Regional Pain Syndrome

Not Applicable

Recruiting

• Conditions: Stellate Ganglion Block

• Registration Number: NCT07129811
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study Start: 2025-01-15
• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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

Secondary Outcome Measures

Name	Time	Method
Brunnstroom stages of stroke recovery (BSSR)	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).
Fugl-Meyer Upper Extremity (FMUE) Scale	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.
Stroke Specific Quality of Life scale (SS-QOL).	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.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Çankaya, Turkey