The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency Treatment in Chronic Soulder Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Shoulder Impingement Syndrome; Pulsed Radiofrequency; Supraspinatus Tendinopathy; Suprascapular Nerve
• Intervention / Treatment: Procedure: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve; Procedure: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve

Detailed Description

Pulsed radiofrequency (pRF) treatment of suprascapular nerve can be used successfully to alleviate pain due to shoulder impingement syndrome and supraspinatus tendinosis. Radiofrequency waves produced by radiofrequency (RF) generator through pRF modality are applied to suprascapular nerve and create magnetic field. This field leads to pain modulation by changing neuronal activity and resulting in long term depression of pain transmitting nerve fibers. Temperature around nerve never exceeds 42 degree and by this way the nerve can be protected from coagulation necrosis and demiyelinisation. pRF can be used in the treatment of mixed type nerves such as suprascapular nerve. There are preclinical and clinical studies which report that with longer pRF duration, more favorable analgesia. Suprascapular pRF is performed with 22G, 10 cm, 5 mm active lead RF needle via USG guided posterior approach as institution procotol. Howeveri clinicians can choose any duration of pRF. Instution's pain medicine practitioners HAU and GEO choose 4 and 9 minutes of pRF duration, respectively. Investigators' aim is to investigate the efficacy of two different pRF duration, 4 and 9 minutes, on Shoulder Pain and Disability Index (SPADI) and Numeric Rating Scale-11(NRS-11) at 3 month follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanzade Aybuke Unal, MD; Phone Number: +905057179039; Email: hanzadeunal@windowslive.com
• Study Contact Backup: Name: Ersin Sönmez, MD; Phone Number: +905370257858; Email: ersins@outlook.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 4 min suprascapular pulsed RF; Suprascapular nerve pulsed RF is applied for 4 minutes.	Procedure: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve; suprascapular nerve pulsed rf
Other: 9 min suprascapular pulsed RF; Suprascapular nerve pulsed RF is applied for 8 minutes.	Procedure: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve; suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprocedure pain severity at first week	Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 week after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.	From procedure to 1 week after procedure
Postprocedure first month pain severity	Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 month after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.	From procedure to 1 month after procedure
Postprocedure SPADI scores at first week	Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 1 week. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.	From procedure to 1 week after procedure
Postprocedure first month SPADI scores	Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 1 month. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.	From procedure to 1 month after procedure
Postprocedure 3th month SPADI scores	Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 3th month. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.	From procedure to 3 month after procedure

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Director: Güngör Enver Özgencil, Prof Dr, Ankara University School of Medicine Department of Anesthesiology and Reanimation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; pulsed radiofrequency; suprascapular nerve; impingement syndrome; Supraspinatus tendinopathy
• Additional Relevant MeSH Terms: Shoulder Injuries; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Joint Diseases; Tendon Injuries; Chronic Pain; Shoulder Impingement Syndrome; Tendinopathy
• Other Study ID Numbers: 2024/765

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data can be shared except personal data.
• IPD Sharing Time Frame: 5 years after January 2026
• IPD Sharing Access Criteria: Upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No