Efficacy of Suprascapular Radiofrequency Ablation in Hemiplegic Shoulder Pain

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiplegic Shoulder Pain
• Intervention / Treatment: Procedure: Suprascapular nerve pulse radiofrequency ablation; Procedure: Suprascapular Nerve Block Group; Procedure: Steroid Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YUNUS BURAK BAYIR, SPECİALİST; Phone Number: 05058083317; Email: yunusburakbayir@gmail.com
• Study Contact Backup: Name: Fatma BALLI UZ, specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulse Radiofrequency Ablation; Pulse RF application will be applied to the suprascapular nerve once under US guidance with a TOP-TLG10 STP generator at a maximum temperature of 42 degrees, 2 Hz, 20 ms and 45 V for 2 minutes.	Procedure: Suprascapular nerve pulse radiofrequency ablation; Pulse RF application will be applied to the suprascapular nerve once under US guidance with a TOP-TLG10 STP generator at a maximum temperature of 42 degrees, 2 Hz, 20 ms and 45 V for 2 minutes.
Active Comparator: Suprascapular Nerve Block Injection; Suprascapular block will be performed once with a mixture consisting of 5 ml (1 ml betamethasone, 2% lidocaine 2 ml, 0.9% saline 2 ml).	Procedure: Suprascapular Nerve Block Group; Suprascapular block will be applied once with a mixture consisting of 5 ml (1 ml betamethasone, 2% lidocaine 2 ml, 0.9% saline 2 ml).
Active Comparator: Intra-articular Steroid İnjection; Intra-articular steroid will be performed once with a mixture consisting of 5 ml (2 ml lidocaine 2 ml, 0.9% saline 2 ml and 1 ml betamethasone 5 mg).	Procedure: Steroid Group; Intra-articular steroid application will be made with a mixture consisting of 5 ml (2 ml of 2% lidocaine, 2 ml of 0.9% saline and 1 ml of betamethasone 5 mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Shoulder pain.The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.	This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
painful angle of the shoulder	painful angle of the shoulder	This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	range of motion (ROM; flexion, abduction, internal and external rotation)	This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Goal Attainment Scale (GAS)	Goal Attainment Scale (GAS) during upper-body dressingIn the functional evaluation, the GAS during upper-body dressing was used to assess the effect of shoulder pain on functional capacity. GAS is a mathematical tech- nique for quantifying the achievement (or otherwise) of goals set, and it can be used in rehabilitation (7). According to this scale, pain during upper extremity dressing was evaluated (-2: severe pain, -1: moderate pain, 0: mild pain, +1: pain at the end of movement, and +2: painless motion. The highest indicating the best score.	This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Modified Barthel Index	Physical competence and independence in daily living activities will be evaluatedIn the modified Barthel index, the level of functional independence in a total of 10 activities such as transfer, movement, stairs, nutrition, dressing, personal care, bathing, sitting and rising to the toilet, urinary and faecal incontinence is evaluated. The total score varies between 0-100. Zero score indicates complete dependence and 100 score indicates complete independence.	This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
SPADI	Shoulder Pain and Disability Index scoreIt is a 13-item questionnaire categorised into pain and activity limitation. The score ranges from 0-100.The highest indicating the best score.	This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.

Collaborators and Investigators

• Sponsor: YBBayır
• Investigators: Study Chair: DAMLA CANKURTARAN, ASSOC. PROF., Ankara Etlik City Hospital; Study Chair: Ebru KARACA UMAY, prof., Ankara Etlik City Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: pain; stroke; corticosteroid; suprascapular nerve; radiofrequency; injection; Hemiplegic shoulder
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: Suprascapular Rf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No