The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

NCT06713005 | Not Yet Recruiting

• 1 other identifier: 2024/765
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic shoulder pain due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. To prolong analgesia, short bursts of electrical stimulation to suprascapular nerve may be applied. To the date there is no consensus about duration of these type of stimulation. Investigators' aim is to investigate efficacy of two different duration of stimulation (pulsed radiofrequency) on chronic shoulder pain.

Conditions

Suprascapular Nerve; Shoulder Impingement Syndrome; Pulsed Radiofrequency; Chronic Pain; Supraspinatus Tendinopathy

Keywords

pulsed radiofrequency; suprascapular nerve; chronic pain; impingement syndrome; Supraspinatus tendinopathy

Outcome Measures

Primary Outcomes (1)

• Postprocedure 3th month pain severity

  Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at baseline, 1 weeks, 1 months and 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.

  From procedure to 3 months after prodecure

Secondary Outcomes (5)

• Postprocedure pain severity at first week

  From procedure to 1 week after procedure

• Postprocedure first month pain severity

  From procedure to 1 month after procedure

• Postprocedure SPADI scores at first week

  From procedure to 1 week after procedure

• Postprocedure first month SPADI scores

  From procedure to 1 month after procedure

• Postprocedure 3th month SPADI scores

  From procedure to 3 month after procedure

Study Arms (2)

4 min suprascapular pulsed RF

OTHER

Suprascapular nerve pulsed RF is applied for 4 minutes.

Procedure: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

9 min suprascapular pulsed RF

OTHER

Suprascapular nerve pulsed RF is applied for 8 minutes.

Procedure: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve

Interventions

suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve PROCEDURE

suprascapular nerve pulsed rf

4 min suprascapular pulsed RF

suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve PROCEDURE

suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

9 min suprascapular pulsed RF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• Shoulder pain caused by impingement syndrome
• Shoulder pain due to supraspinatus tendinosis
• Diagnosis of impingement syndrome and supraspinatus tendinosis confirmed through physical examination and radiological imaging (MRI)
• Pain persisting for 3 months or longer
• Numeric Pain Rating Scale (NRS) score of 4 or higher despite conservative treatment

You may not qualify if:

• Patients unwilling to participate in the study
• Presence of chronic pain due to other conditions
• Presence of cervical radiculopathy
• History of opioid use
• Uncontrolled diabetes (HbA1c \> 8)
• History of shoulder surgery on the affected side
• Uncontrolled psychiatric disorders despite medical treatment
• History of cancer
• History of stroke

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Gupta SK, Ghai B, Makkar JK, Dhiman D, Chouhan DK. Effectiveness of ultrasound-guided pulsed radiofrequency ablation of suprascapular nerve versus local anaesthetics with steroids in patients with chronic shoulder pain: A randomised controlled trial. Indian J Anaesth. 2024 Aug;68(8):731-734. doi: 10.4103/ija.ija_939_23. Epub 2024 Jul 2. No abstract available.

  PMID: 39176114 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Güngör Enver Özgencil, Prof Dr

  Ankara University School of Medicine Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Central Study Contacts

Hanzade Aybuke Unal, MD

CONTACT

+905057179039; hanzadeunal@windowslive.com

Ersin Sönmez, MD

CONTACT

+905370257858; ersins@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1: 4 mins suprascapular pulsed RF Group 2: 9 mins suprascapular pulsed RF

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 3, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 5 years after January 2026
• Access Criteria: Upon reasonable request

Locations

TU (1)