- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302490
Ultrasound-Guided Suprascapular Nerve RFA vs Steroid-Local Anesthetic Injection in Chronic Shoulder Pain
Comparison of the Effectiveness of Ultrasound-Guided Suprascapular Nerve Radiofrequency Ablation and Ultrasound-Guided Suprascapular Nerve Injection With Local Anesthetic and Corticosteroid in Patients With Chronic Shoulder Pain
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06230
- Ankara Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Active Comparator: 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.
|
Injection of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate into the perineural area under ultrasound guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Shoulder Pain Intensity (VAS Score)
Time Frame: Baseline, 1 month and 3 months after the intervention
|
Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10.
The primary outcome is the change in pain score from baseline to 3 months between the PRF group and the nerve block group.
Higher scores indicate greater pain intensity.
|
Baseline, 1 month and 3 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SPADI (Shoulder Pain and Disability Index) Score
Time Frame: Baseline, 1 month, 3 months
|
The Shoulder Pain and Disability Index (SPADI) assesses shoulder-related pain and functional limitations using a validated 13-item questionnaire.
Scores range from 0 to 100, with higher scores indicating greater pain and disability.
The outcome measure is the change in total SPADI score from baseline to 3 months.
|
Baseline, 1 month, 3 months
|
|
SF-12 (Short Form-12 Health Survey: PCS & MCS)
Time Frame: Baseline, 1 month, 3 months
|
The SF-12 is a validated measure of health-related quality of life that generates Physical and Mental Component Summary scores.
Higher scores reflect better health status.
This outcome assesses the change in SF-12 PCS and MCS scores from baseline to 3 months.
|
Baseline, 1 month, 3 months
|
|
Tampa Scale for Kinesiophobia
Time Frame: Baseline, 1 month, 3 months
|
The Tampa Scale (TSK) for Kinesiophobia evaluates fear of movement or reinjury.
Scores range from 17 to 68, with higher scores indicating greater kinesiophobia.
The outcome is the change in TSK score from baseline to 3 months.
|
Baseline, 1 month, 3 months
|
|
Change in Shoulder Proprioception
Time Frame: Baseline, 1 month, 3 months
|
Shoulder proprioception will be assessed using a closed-kinematic chain angle reproduction test.
Participants attempt to replicate a predetermined joint angle, and the absolute error (in degrees) is recorded.
The outcome measure is the change in angle reproduction error over time.
|
Baseline, 1 month, 3 months
|
|
Change in Supraspinatus Muscle and Tendon Thickness
Time Frame: Baseline, 1 month, 3 months
|
Ultrasound imaging will be used to measure supraspinatus muscle and tendon thickness.
The outcome examines structural changes over time and compares differences between treatment groups.
|
Baseline, 1 month, 3 months
|
|
Change in Shoulder Range of Motion
Time Frame: Baseline, 1 month, 3 months
|
Active shoulder range of motion (flexion, abduction, internal and external rotation) will be measured using a goniometer.
The outcome is the change in ROM values from baseline to 3 months.
|
Baseline, 1 month, 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hakan Genç, MD, Ankara Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Shoulder Injuries
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Wounds and Injuries
- Joint Diseases
- Arthralgia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Chronic Pain
- Shoulder Pain
- Shoulder Impingement Syndrome
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Hypothalamic Hormones
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Nerve Tissue Proteins
- Proteins
- Pharmacologic Actions
- Chemical Actions and Uses
- Therapeutic Uses
- Central Nervous System Agents
- Anesthetics, Local
- Adrenal Cortex Hormones
- Prolactin-Releasing Hormone
Other Study ID Numbers
- SSNRFA2025
- 2024-KAEK-40 (Ankara Etlik City Hospital Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Impingement Syndrome
-
Lokman Hekim UniversityCompletedSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Rotator Cuff Impingement SyndromeTurkey (Türkiye)
-
Mahidol UniversityCompletedSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Subacromial Pain Syndrome | Subacromial Impingement | Impingement Syndrome, ShoulderIndonesia
-
China Medical University HospitalNot yet recruiting
-
California State University, Long BeachEnrolling by invitationSubacromial Impingement Syndrome | Rotator Cuff Syndrome | Apical Shoulder PainUnited States
-
Cairo UniversityCompletedSubacromial Impingement Syndrome | Shoulder Bursitis | Pilates ExerciseEgypt
-
Cairo UniversityRecruitingSubacromial Impingement SyndromeEgypt
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedSubacromial Impingement SyndromeTurkey (Türkiye)
-
Near East University, TurkeyCompletedSubacromial Impingement SyndromeCyprus
-
Uskudar State HospitalNot yet recruitingSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Shoulder Pain | Subacromial Impingement | Shoulder Impingement
-
Copenhagen University Hospital, HvidovreUniversity of Copenhagen; Aalborg University; Metropolitan University CollegeCompletedSubacromial Impingement SyndromeDenmark
Clinical Trials on Pulsed Radiofrequency (PRF) of the Suprascapular Nerve
-
Saint Petersburg State University, RussiaRecruitingChronic Shoulder PainRussian Federation
-
Ankara City Hospital BilkentNot yet recruitingChronic Shoulder Pain | Rotator Cuff TendinopathyTurkey (Türkiye)
-
Mersin UniversityCompletedPostherpetic Neuralgia ( PHN ) | Intercostal Neuralgia | Thoracic Neuropathic PainTurkey (Türkiye)
-
Ankara City Hospital BilkentCompleted
-
Zagazig UniversityRecruiting
-
Ankara City Hospital BilkentCompletedHeadache Disorders | Ultrasound Guided Nerve Block | Migraine, Greater Occipital Nerve Pulsed RadiofrequencyTurkey (Türkiye)
-
Ankara UniversityNot yet recruitingChronic Pain | Shoulder Impingement Syndrome | Pulsed Radiofrequency | Supraspinatus Tendinopathy | Suprascapular NerveTurkey
-
Sakarya UniversityCompletedPAIN, INTRACTABLE, Shoulder
-
Maastricht University Medical CenterZiekenhuis Oost-Limburg; Sint Jozef Hospital Bornem en Willebroek BelgiumCompletedLumbosacral Radicular SyndromeNetherlands
-
Sohag UniversityNot yet recruiting