Clinical trial NCT06473389: Efficacy of Suprascapular Radiofrequency Ablation in Hemiplegic Shoulder Pain
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Keywords: Hemiplegic shoulder
stroke
pain
radiofrequency
suprascapular nerve
corticosteroid
injection
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.Patients will be randomised into three groups of 28 patients as the first group RF Group (RFG), the second group Suprascapular Nerve Blockade Group (SSBG) and the third group Intraarticular Steroid Group (SG) with the 'Research Randomizer' computer program. The treatments 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.The degree of maximum passive ROM measurements of the shoulder, the degree of passive ROM, Visual Analogue Scale (VAS), Shoulder Pain and Disability Index score (SPADI), Goal Attainment Scale (GAS), Modified Barthel Index at baseline, 1st, 4th, 12th weeks.
Primary purpose: TREATMENT

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 duration.Corticosteroids 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, investigator's 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 G\*Power 3.1.9.4 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 programme.Patients, 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, 0.9% 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.

Eligibility criteria: Inclusion Criteria:

1. Being over 18 years old
2. Those who were diagnosed with hemorrhagic or ischemic stroke at least 3 months ago
3. Patients with shoulder pain with VAS \> 5 severity after hemiplegia
4. Those who agree to participate with a consent document (their own or their foster family)

Exclusion Criteria:

1. Those who did not provide a consent document
2. Those under 18 years of age
3. Those who cannot cooperate
4. Severely aphasic patients
5. Patients with shoulder pain VAS \>5 severity
6. Patients who have undergone interventional procedures such as RF, suprascapular nerve blockade, steroid injection, etc. for the shoulder area in the last 3 months
7. Patients with bleeding diathesis
8. Those with a history of surgery or radiotherapy in the shoulder area
9. Those who had shoulder complaints before the stroke
10. Patients with pacemakers
11. Patients with MMT Score \<24

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
measure: painful angle of the shoulder
timeFrame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Secondary outcomes:
measure: range of motion
timeFrame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
measure: Goal Attainment Scale (GAS)
timeFrame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
measure: Modified Barthel Index
timeFrame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
measure: SPADI
timeFrame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
state: Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Damla CANKURTARAN, assoc. prof.
role: STUDY_CHAIR
affiliation: Ankara Etlik City Hospital
name: Ebru KARACA UMAY, prof.
role: STUDY_CHAIR
References:
citation: Alanbay E, Aras B, Kesikburun S, Kizilirmak S, Yasar E, Tan AK. Effectiveness of Suprascapular Nerve Pulsed Radiofrequency Treatment for Hemiplegic Shoulder Pain: A Randomized-Controlled Trial. Pain Physician. 2020 Jun;23(3):245-252.
citation: Chiu YH, Chang KV, Wu WT, Hsu PC, Ozcakar L. Comparative Effectiveness of Injection Therapies for Hemiplegic Shoulder Pain in Stroke: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2021 Aug 10;14(8):788. doi: 10.3390/ph14080788.
citation: Kim TH, Chang MC. Comparison of the effectiveness of pulsed radiofrequency of the suprascapular nerve and intra-articular corticosteroid injection for hemiplegic shoulder pain management. J Integr Neurosci. 2021 Sep 30;20(3):687-693. doi: 10.31083/j.jin2003073.