Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473389
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-12
Brief Title:
Efficacy of Suprascapular Radiofrequency Ablation in Hemiplegic Shoulder Pain
Sponsor:
YBBayır
Organization:
Ankara Etlik City Hospital
Study Overview
Official Title:
Efficacy of Suprascapular Radiofrequency Ablation Versus USG-guided Suprascapular Nerve Blockade and Intra-articular Steroid Injections in Hemiplegic Shoulder Pain A Three-blind Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke one of the most important causes of disability and death in the world is an acute focal deficit of the central system caused by vascular origin such as cerebral infarction intracerebral haemorrhage and subarachnoid haemorrhage Hemiplegic shoulder pain which is one of the most common complications after stroke is an important problem affecting extremity rehabilitation Although there are many factors thought to cause haemiplegic shoulder pain there is still controversy about its treatment Although there are many treatment strategies for this complication such as analgesics antispasmotics local corticosteroid injections suprascapular nerve blockade physical therapy modalities and exercise therapy sometimes very resistant cases are also seen For the treatment of persistent haemiplegic shoulder pain unresponsive to conventional treatment modalities intra-articular injection of corticosteroids into the shoulder joint is commonly used but its palliative effect has only a relatively short durationCorticosteroids may also have adverse effects such as allergic reactions rash hyperglycaemia menstrual disorders and adrenal suppression Suprascapular nerve block is another option to relieve haemiplegic shoulder pain The suprascapular nerve provides 70 of the sensory innervation of the shoulder joint Thus blocking pain transmission through the SS provides effective control of haemiplegic shoulder pain However the efficacy of suprascapular nerve block varies according to the study population and depends on the therapeutic modality to which it is compared In addition the effect of suprascapular nerve blockade may be limited due to the short duration of action of local anaesthetic agents Neurolysis may cause permanent paralysis of the supraspinatus and infraspinatus muscles For this reason a deconstructive method is not preferred Pulse RF applications which is a non-deconstructive neuromodulatory method may be preferred in this regard So far there are very few studies investigating the efficacy of intra-articular steroid injection suprascapular block and pulse RF in hemiplegic shoulder pain separately but there is no study investigating the efficacy of Pulse RF treatment against other treatment methods together In this study investigators aim was to compare the efficacy of suprascapular pulse radiofrequency against USG-guided suprascapular nerve block and intra-articular steroid injections in hemiplegic shoulder pain
Detailed Description:
This study was designed as a prospective triple-blind randomised controlled study Patients hospitalised in the stroke clinic of our hospital and diagnosed with haemorrhagic or ischaemic stroke will be included in our study Sample size was calculated using the statistical power analysis programme GPower 3194 for Windows Based on the study by Allen et al evaluating the efficacy of suprascapular nerve block in post-stroke shoulder pain the minimum number of patients required to achieve a significant change of 20 mm in VAS assessment before and after treatment with a 5 Type 1 and 20 Type 2 margin of error 80 working power and 95 confidence interval was found to be 23 total 69 patients for each group Considering the possibility of 20 loss during the study it was decided to include at least 28 total 84 patients for each group Patients who met the inclusion criteria and completed the Informed Volunteer Consent Forum will be randomised into three groups of 28 patients as the first group RF Group RFG the second group Suprascapular Nerve Blockage Group SSBG and the third group Intraarticular Steroid Group SG with the Research Randomizer computer programmePatients the physician performing the assessment and the physiotherapist treating the patient will be blinded to which procedure is performed A blinded investigator will perform baseline assessments of the participants before the injection While Transcutaneous Electrical Nerve Stimulation TENS hotpack and exercise treatments which are frequently used in the treatment of hemiplegic shoulder pain were performed in all patients in addition to the patients selected to the PRF group with the Research Randomizer computer programme pulse RF application with TOP-TLG10 STP generator at 2 Hz 20 ms and 45 V for 2 minutes at 2 Hz 20 ms and 45 V at a maximum temperature of 42 degrees once to the suprascapular nerve under US guidance 5 ml of 1 ml betamethasone 2 lidocaine 2 ml 0 9 Serum Physiological 2 ml mixture will be applied to the suprascapular block group and intra-articular steroid application with a mixture of 2 lidocaine 2 ml 09 Serum Physiological 2 ml and 1 ml betamethasone 5 mg will be applied to the steroid group All procedures will be performed with a portable ultrasonography system with a 12 MHz linear probe and exercises will be performed under the supervision of a physiotherapist The treatment of the patients will be organised as a total of 20 sessions for 4 weeks 5 days a week first TENS and hotpack then exercise 15 minutes of hotpack 15 minutes of TENS will be applied followed by 30 minutes of upper extremity exercises
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None