Stellate Ganglion Block in Complex Regional Pain Syndrome

Ankara City Hospital

Status: Enrolling

Conditions: Stellate Ganglion Block

Treatments: Procedure: Stellate Ganglion Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07129811

TABED 1-24-804

Ankara Bilkent City Hospital (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Stellat Group

Active Comparator group

Description:

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

Treatment:

Procedure: Stellate Ganglion Block

Only Physical Therapy Group

No Intervention group

Description:

Group 2 will receive only conventional physical therapy and exercise therapy