Efficacy of Suprascapular Radiofrequency Ablation in Hemiplegic Shoulder Pain

NCT06473389 | Recruiting

• 1 other identifier: Suprascapular Rf
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Shoulder Pain

Keywords

Hemiplegic shoulder; stroke; pain; radiofrequency; suprascapular nerve; corticosteroid; injection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• range of motion

  This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.

• Goal Attainment Scale (GAS)

  This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.

• Modified Barthel Index

  This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.

• SPADI

  This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.

Study Arms (3)

Pulse Radiofrequency Ablation

ACTIVE COMPARATOR

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

Suprascapular Nerve Block Injection

ACTIVE COMPARATOR

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

Intra-articular Steroid İnjection

ACTIVE COMPARATOR

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

Interventions

Suprascapular nerve pulse radiofrequency ablation PROCEDURE

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.

Pulse Radiofrequency Ablation

Suprascapular Nerve Block Group PROCEDURE

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).

Suprascapular Nerve Block Injection

Steroid Group PROCEDURE

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).

Intra-articular Steroid İnjection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yunus Burak Bayır: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 32517390 RESULT

• 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.

  PMID: 34451885 RESULT

• 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.

  PMID: 34645102 RESULT

MeSH Terms

Conditions

Stroke; Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Damla CANKURTARAN, assoc. prof.

  Ankara Etlik City Hospital

  STUDY CHAIR

• Ebru KARACA UMAY, prof.

  Ankara Etlik City Hospital

  STUDY CHAIR

Central Study Contacts

YUNUS BURAK BAYIR, specialist

CONTACT

05058083317; yunusburakbayir@gmail.com

Fatma BALLI UZ, specialist

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients and care provider, the physician performing the assessment and the physiotherapist treating the patient will be blind to what procedure is being performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yunus Burak Bayır, Specialist

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 25, 2024
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)