Chronic Shoulder PainNCT07302490
Ultrasound-Guided Suprascapular Nerve RFA vs Steroid-Local Anesthetic Injection in Chronic Shoulder Pain
A study testing Pulsed Radiofrequency (PRF) of the Suprascapular Nerve and Suprascapular Nerve Block with Local Anesthetic and Corticosteroid in people with Chronic Shoulder Pain and Shoulder Impingement Syndrome, run by Nida Koçer Nazlıgül at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff-Related Shoulder Pain
- What is being tested?
- Pulsed Radiofrequency (PRF) of the Suprascapular Nerve and Suprascapular Nerve Block with Local Anesthetic and Corticosteroid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2025to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, 06230
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff-Related Shoulder Pain, Suprascapular Nerve-Related Shoulder Pain
- Being tested
- Pulsed Radiofrequency (PRF) of the Suprascapular Nerve, Suprascapular Nerve Block with Local Anesthetic and Corticosteroid
- Keywords
- Suprascapular nerve, Pulsed radiofrequency, PRF, Suprascapular nerve block, Shoulder pain, Chronic pain, Ultrasound-guided interventions, Corticosteroid injection, Local anesthetic injection, Shoulder proprioception
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Radiofrequency (PRF) of the Suprascapular NerveProcedure or surgery
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 CorticosteroidProcedure or surgery
Injection of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate into the perineural area under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| PRF Group | Active comparator | 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. Receives: Procedure: Pulsed Radiofrequency (PRF) of the Suprascapular Nerve |
| Nerve Block Group | Active comparator | Participants receive suprascapular nerve block under ultrasound guidance consisting of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate injected into the perineural area. Receives: Procedure: Suprascapular Nerve Block with Local Anesthetic and Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain Intensity (VAS Score)
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.
Measured: Baseline, 1 month and 3 months after the intervention
Secondary outcomes (6)
SPADI (Shoulder Pain and Disability Index) Score
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.
Measured: Baseline, 1 month, 3 months
SF-12 (Short Form-12 Health Survey: PCS & MCS)
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.
Measured: Baseline, 1 month, 3 months
Tampa Scale for Kinesiophobia
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.
Measured: Baseline, 1 month, 3 months
Change in Shoulder Proprioception
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.
Measured: Baseline, 1 month, 3 months
Change in Supraspinatus Muscle and Tendon Thickness
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.
Measured: Baseline, 1 month, 3 months
Change in Shoulder Range of Motion
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.
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start27 Jul 2025
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nida Koçer Nazlıgül
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nida Koçer Nazlıgül, Ankara City Hospital Bilkent
- Investigators
- Hakan Genç, MD, Principal investigator, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302490
- Sponsor's protocol ID
- SSNRFA2025
- Other IDs
- 2024-KAEK-40
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves identifiable clinical information collected in a single-center setting, and current institutional and national data protection regulations do not allow the external distribution of patient-level datasets. Only aggregated results will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07302490
- Acronym / sponsor ID
- SSNRFA2025
- Conditions
- Chronic Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff-Related Shoulder Pain, Suprascapular Nerve-Related Shoulder Pain
- Keywords
- Suprascapular nerve, Pulsed radiofrequency, PRF, Suprascapular nerve block, Shoulder pain, Chronic pain, Ultrasound-guided interventions, Corticosteroid injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Nida Koçer NazlıgülUniversity, hospital or other
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRF Group | Active comparator | Procedure: Pulsed Radiofrequency (PRF) of the Suprascapular NerveParticipants 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. |
| Nerve Block Group | Active comparator | Procedure: Suprascapular Nerve Block with Local Anesthetic and CorticosteroidParticipants receive suprascapular nerve block under ultrasound guidance consisting of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate injected into the perineural area. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Radiofrequency (PRF) of the Suprascapular NerveSingle-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. | Procedure or surgery | PRF Group |
| Suprascapular Nerve Block with Local Anesthetic and CorticosteroidInjection of 2 mL 2% lidocaine and 2 mL methylprednisolone acetate into the perineural area under ultrasound guidance. | Procedure or surgery | Nerve Block Group |
Primary outcome
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.
6 secondary outcomes
SPADI (Shoulder Pain and Disability Index) Score
Time frame: Baseline, 1 month, 3 months
SF-12 (Short Form-12 Health Survey: PCS & MCS)
Time frame: Baseline, 1 month, 3 months
Tampa Scale for Kinesiophobia
Time frame: Baseline, 1 month, 3 months
Change in Shoulder Proprioception
Time frame: Baseline, 1 month, 3 months
Change in Supraspinatus Muscle and Tendon Thickness
Time frame: Baseline, 1 month, 3 months
Change in Shoulder Range of Motion
Time frame: Baseline, 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves identifiable clinical information collected in a single-center setting, and current institutional and national data protection regulations do not allow the external distribution of patient-level datasets. Only aggregated results will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Genç, MD principal investigator
Ankara Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency (PRF) of the Suprascapular Nerve and Suprascapular Nerve Block with Local Anesthetic and Corticosteroid in people with Chronic Shoulder Pain and Shoulder Impingement Syndrome, run by Nida Koçer Nazlıgül at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain Intensity (VAS Score) (time frame: Baseline, 1 month and 3 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.