Ultrasound-Guided Suprascapular Nerve RFA vs Steroid-Local Anesthetic Injection in Chronic Shoulder Pain
NCT ID: NCT07302490
Last Updated: 2025-12-24
Study Results
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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COMPLETED
NA
104 participants
INTERVENTIONAL
2025-07-27
2025-12-08
Brief Summary
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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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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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Voluntary participation and ability to provide written informed consent for enrollment in the study.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Nida Koçer Nazlıgül
OTHER
Responsible Party
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Nida Koçer Nazlıgül
Physical Medicine and Rehabilitation Specialist (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)
Countries
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Other Identifiers
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2024-KAEK-40
Identifier Type: OTHER
Identifier Source: secondary_id
SSNRFA2025
Identifier Type: -
Identifier Source: org_study_id