Ultrasound-Guided Suprascapular Nerve RFA vs Steroid-Local Anesthetic Injection in Chronic Shoulder Pain

NCT ID: NCT07302490

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-27

Study Completion Date

2025-12-08

Brief Summary

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This study aims to compare the clinical effectiveness of two interventional treatments for chronic shoulder pain related to suprascapular nerve pathology: ultrasound-guided suprascapular nerve block and suprascapular nerve radiofrequency ablation (RFA).

A total of 104 patients with chronic shoulder pain were enrolled and assigned to one of the two treatment groups. Participants were evaluated at baseline, 1 month, and 3 months after the intervention. Outcome measures included pain intensity, functional disability, range of motion, kinesiophobia, quality of life, shoulder proprioception, and supraspinatus muscle and tendon thickness measured by ultrasound.

The primary aim of the study is to determine whether radiofrequency ablation provides more sustained pain relief and functional improvement compared with nerve block. The findings may help guide clinical decision-making in the management of chronic shoulder pain.

Detailed Description

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Chronic shoulder pain is a common clinical condition that leads to functional limitation and reduced quality of life. This study aimed to compare the effectiveness of two interventional treatments in patients whose symptoms persisted despite conservative management: pulsed radiofrequency (PRF) of the suprascapular nerve under ultrasonographic guidance, and suprascapular nerve blockade with local anesthetic and corticosteroid.

Adult patients with at least 3 months of chronic shoulder pain, diagnosed with a shoulder pathology based on clinical evaluation and, when necessary, imaging, were included. Eligible participants underwent either PRF treatment or perineural injection of local anesthetic and corticosteroid. All patients were instructed in a home-based exercise program that included Codman exercises, scapular stabilization exercises, and strengthening of the internal and external rotator muscles.

All interventions were performed under real-time ultrasonographic guidance. For PRF, the suprascapular notch region was visualized, and a radiofrequency cannula was advanced toward the suprascapular nerve using an in-plane approach. Correct needle positioning was confirmed through standard sensory and motor stimulation techniques. PRF was then delivered at a maximum temperature of 42°C for a total duration of 6 minutes. At the end of the procedure, 2 mL of 2% lidocaine was administered.

In the nerve block group, a spinal needle was advanced to the perineural region using the in-plane technique. After negative aspiration, 4 mL of solution containing 2 mL of 2% lidocaine and 2 mL of methylprednisolone acetate was slowly injected, and appropriate perineural spread was confirmed sonographically.

Following each procedure, all patients were observed for at least 30 minutes and monitored for potential complications such as hematoma, infection, or neurological deficit. Mild procedural soreness was managed with ice application or simple analgesics as needed.

Participants were evaluated at baseline, at 1 month, and at 3 months post-intervention. Outcome measures included pain intensity, functional disability, range of motion, kinesiophobia, quality of life, shoulder proprioception assessed with the closed-kinematic chain angle reproduction test, and supraspinatus muscle and tendon thickness measured by ultrasonography. The primary objective was to determine whether PRF produced longer-lasting pain reduction and functional improvement compared with nerve block. Secondary objectives were to assess differences in proprioception, shoulder mobility, psychological factors related to pain, and ultrasound-based structural changes.

This study sought to comprehensively evaluate the relative effectiveness of two minimally invasive treatments for chronic shoulder pain using clinical, functional, psychological, and imaging-based outcome measures.

Conditions

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Chronic Shoulder Pain Shoulder Impingement Syndrome Rotator Cuff-Related Shoulder Pain Suprascapular Nerve-Related Shoulder Pain

Keywords

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Suprascapular nerve Pulsed radiofrequency PRF Suprascapular nerve block Shoulder pain Chronic pain Ultrasound-guided interventions Corticosteroid injection Local anesthetic injection Shoulder proprioception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one of two parallel groups: suprascapular nerve pulsed radiofrequency (PRF) or suprascapular nerve block with local anesthetic and corticosteroid. Both interventions are administered once under ultrasound guidance. Follow-up assessments at baseline, 1 month, and 3 months will compare outcomes related to pain, functional disability, range of motion, shoulder proprioception, quality of life, and ultrasound-based measurements of supraspinatus muscle and tendon thickness.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRF Group

Participants undergo a single-session pulsed radiofrequency (PRF) procedure applied to the suprascapular nerve under ultrasound guidance. PRF is delivered at a maximum temperature of 42°C for a total of 6 minutes. At the end of the procedure, 2 mL of 2% lidocaine is injected into the perineural area.

Group Type ACTIVE_COMPARATOR

Pulsed Radiofrequency (PRF) of the Suprascapular Nerve

Intervention Type PROCEDURE

Single-session PRF applied to the suprascapular nerve under ultrasound guidance. PRF is delivered at 42°C for 6 minutes. At the end of the procedure, 2 mL of 2% lidocaine is injected into the perineural area.

Nerve Block Group

Participants receive suprascapular nerve block under ultrasound guidance consisting of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate injected into the perineural area.

Group Type ACTIVE_COMPARATOR

Suprascapular Nerve Block with Local Anesthetic and Corticosteroid

Intervention Type PROCEDURE

Injection of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate into the perineural area under ultrasound guidance.

Interventions

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Pulsed Radiofrequency (PRF) of the Suprascapular Nerve

Single-session PRF applied to the suprascapular nerve under ultrasound guidance. PRF is delivered at 42°C for 6 minutes. At the end of the procedure, 2 mL of 2% lidocaine is injected into the perineural area.

Intervention Type PROCEDURE

Suprascapular Nerve Block with Local Anesthetic and Corticosteroid

Injection of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate into the perineural area under ultrasound guidance.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Adults aged 18 to 75 years, male or female. Presence of shoulder pain and/or mobility limitation for at least 3 months. Failure to benefit from medical treatment and exercise-based conservative therapy.

Voluntary participation and ability to provide written informed consent for enrollment in the study.

Exclusion Criteria

Age younger than 18 years or older than 75 years. Shoulder pain caused by non-shoulder conditions such as cervical radiculopathy or myofascial pain syndrome.

Presence of severe chronic respiratory disease. History of intra-articular, peri-articular, or suprascapular nerve injection, or use of physical therapy modalities applied to the affected shoulder within the past 3 months.

Diagnosis of fibromyalgia. Presence of complex regional pain syndrome, entrapment neuropathy, or vascular disease affecting the same upper extremity.

Coagulopathy or bleeding diathesis. Presence of inflammatory or malignant disease. Severe psychiatric disorder or mental condition impairing cooperation or compliance.

Refusal to participate or inability to provide informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nida Koçer Nazlıgül

OTHER

Sponsor Role lead

Responsible Party

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Nida Koçer Nazlıgül

Physical Medicine and Rehabilitation Specialist (Sponsor-Investigator)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hakan Genç, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Research Hospital

Locations

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Ankara Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024-KAEK-40

Identifier Type: OTHER

Identifier Source: secondary_id

SSNRFA2025

Identifier Type: -

Identifier Source: org_study_id