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| ID | Type | Description | Link |
|---|---|---|---|
| Ankara Bilkent City Hospital | Other Identifier | Ankara Bilkent City Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellat Group | Active Comparator | In group 1, stellate ganglion blockade will be applied in addition to conventional physical therapy. |
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| Only Physical Therapy Group | No Intervention | Group 2 will receive only conventional physical therapy and exercise therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brunnstroom stages of stroke recovery (BSSR) | 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). | before treatment, 2 weeks and 12 weeks after the end of the therapy sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seher KALIÇ MD | Contact | +905393628565 | seherkalic@icloud.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | Çankaya | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23185727 | Result | 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. | |
| 24760493 | Result | 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. |
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Its going to be shared after the end of study
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D059350 | Chronic Pain |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
| Fugl-Meyer Upper Extremity (FMUE) Scale |
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. |
| before treatment, 2 weeks and 12 weeks after the end of the therapy sessions |
| Stroke Specific Quality of Life scale (SS-QOL). | 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. | before treatment, 2 weeks and 12 weeks after the end of the therapy sessions |
| 35687369 | Result | 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. |
| 32807418 | Result | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |