Shoulder PainSSPRF-CSNCT06857409
Suprascapular Nerve PRF for Central Sensitization and Neuropathic Pain
An observational study of Shoulder Pain, run by Gülçin Babaoğlu at 1 site in Turkey (Türkiye).
Trial summary
Chronic shoulder pain affects quality of life and is often associated with central sensitization, leading to treatment resistance. Pulsed radiofrequency (PRF) of the suprascapular nerve, which innervates 70% of the shoulder joint, is a promising therapy for nociceptive and neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- pulsed radiofrequency
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2025to 5 May 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic shoulder pain persisting for at least 3 months
Who may be able to join
- Chronic shoulder pain persisting for at least 3 months
- Radiologically confirmed shoulder lesions, including:
- Rotator cuff tendinopathy Adhesive capsulitis Bursitis Osteoarthritis
- At least two positive provocation tests (Neer, Hawkins, Jobe tests)
- Shoulder pain resistant to conservative treatments, including:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) Physical therapy Corticosteroid injections
Who cannot join
- Traumatic shoulder pain (e.g., fractures, dislocations)
- History of shoulder surgery
- Active inflammation or rheumatic diseases affecting the shoulder, including:
- Rheumatoid arthritis Polymyalgia rheumatica Ankylosing spondylitis
- Cervical radiculopathy
- Central nervous system diseases, such as:
- Multiple sclerosis Stroke Spinal cord injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Suprascapular Nerve Pulsed Radiofrequency Treatment on Central Sensitization and Neuropathic Pain
Chronic shoulder pain affects quality of life and is often associated with central sensitization, leading to treatment resistance. Pulsed radiofrequency (PRF) of the suprascapular nerve, which innervates 70% of the shoulder joint, is a promising therapy for nociceptive and neuropathic pain. This study evaluates the effects of PRF on central sensitization and neuropathic pain in chronic shoulder pain. Clinical assessments will be conducted at baseline, 1 month, and 3 months post-treatment to determine PRF's potential in reducing central sensitization and improving shoulder function.
Read the detailed description
Chronic shoulder pain is a prevalent musculoskeletal condition affecting quality of life, with an incidence of 18-26% in the general population. Its prevalence has doubled over the past 40 years. Pain sensitization, independent of etiology, is frequently observed in patients with musculoskeletal shoulder pain and can lead to poorer clinical outcomes even after primary disease treatment. Chronic pain development involves both peripheral and central sensitization mechanisms, with central sensitization characterized by amplified pain signaling and reduced inhibitory pathway activity. This can result in pain persistence independent of tissue damage and resistance to treatment.
Conventional treatments for chronic shoulder pain include physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and intra-articular steroid injections. However, these may not provide sufficient long-term analgesia, and some patients develop treatment-resistant chronic pain. Recently, pulsed radiofrequency (PRF) treatment applied to the suprascapular nerve, responsible for 70% of the sensory innervation of the shoulder joint, has gained attention for its efficacy in reducing both nociceptive and neuropathic pain. PRF modulates neural activity without causing thermal damage and may have the potential to reduce central sensitization. However, its effects on central sensitization and neuropathic pain mechanisms remain insufficiently studied.
This study aims to evaluate the impact of suprascapular nerve PRF on central sensitization and neuropathic pain in chronic shoulder pain. Clinical assessments will be conducted at baseline, 1 month, and 3 months post-treatment to examine changes in central sensitization, neuropathic pain, and shoulder function. This study seeks to determine whether PRF can serve as an effective alternative in chronic shoulder pain management by reducing central sensitization and improving quality of life.
- Conditions
- Shoulder Pain
- Being tested
- pulsed radiofrequency
- Keywords
- shoulder pain, suprascapular nerve, radiofrequency, central sensitization, neuropatic pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed radiofrequencyProcedure or surgery
All patients will be monitored with electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation, and peripheral intravenous vascular access will be performed before the procedure. Patients will be placed in a sitting position. The physician will stand behind the patient for the posterior approach. The skin area to be injected will be prepared and covered in a sterile manner using a povidone-iodine-based solution. The operator will use ultrasound (a TOSHIBA Aplio 500 Ultrasound) guidance to perform suprascapular nerve radiofrequency. The suprascapular notch will be visualized. A twenty-two gauge, 10 cm long, and 10 mm active-tipped radiofrequency cannula will be introduced to the suprascapular notch. Motor stimulation will be performed at 2 Hz at a setting of 1 V, and sensory stimulation will be performed at 50 Hz at a setting of 0.5 V. After the needle tip confirmation, pulsed radiofrequency will be applied to the suprascapular nerve for 360 seconds.
| Study group | Role | What they receive |
|---|---|---|
| suprascapular nerve pulsed radiofrequency | patients undergoing suprascapular nerve pulsed radiofrequency therapy Receives: Procedure: pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory (CSI)
The CSI will be used to assess symptoms related to CS. The CSI will consist of two parts, Part A and Part B. Part A will include 25 items scored on a scale from 0 to 100, with higher scores indicating an increased CS-related symptom burden. In Part B, diagnoses of central sensitivity syndromes will be questioned, and this part will not be included in the scoring.
Measured: baseline, 1st and 3rd months
Secondary outcomes (3)
Douleur Neuropathique 4 (DN4) Questionnaire
The DN4 questionnaire is a screening tool used to identify neuropathic pain. It consists of 10 items, with seven related to sensory symptoms (burning, painful cold, electric shocks, tingling, pins and needles, numbness, and itching) and three based on a clinical examination (hypoesthesia to touch, hypoesthesia to pinprick, and pain triggered by brushing). Each item is scored as 1 (present) or 0 (absent), with a total score ranging from 0 to 10.
Measured: baseline, 1st and 3rd months
Numerical Rating Scale (NRS)
The Numerical Rating Scale (NRS) is a widely used pain assessment tool that allows patients to rate their pain intensity on a scale from 0 to 10, where:
0 = No pain 10 = Worst imaginable pain
Measured: baseline, 1st and 3rd months
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-reported questionnaire designed to assess pain and functional impairment in individuals with shoulder disorders. It consists of 13 items divided into two subscales:
Pain Subscale (5 items) - Evaluates the intensity of shoulder pain during different activities.
Disability Subscale (8 items) - Assesses the difficulty in performing daily activities due to shoulder problems.
Each item is scored on a numerical scale from 0 to 10, with 0 = no pain or difficulty and 10 = worst pain or extreme difficulty. The total score ranges from 0 to 100, with higher scores indicating greater pain and disability.
Measured: baseline, 1st and 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start27 Feb 2025
- Primary completion1 Oct 2025
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gülçin Babaoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gülçin Babaoğlu, Ankara City Hospital Bilkent
- Investigators
- ERKAN YAVUZ AKÇABOY, Prof. Dr., Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857409
- Sponsor's protocol ID
- TABED 2-25-949
- Acronym
- SSPRF-CS
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suprascapular Nerve Pulsed Radiofrequency Treatment on Central Sensitization and Neuropathic Pain
- ClinicalTrials.gov ID
- NCT06857409
- Acronym / sponsor ID
- SSPRF-CS / TABED 2-25-949
- Conditions
- Shoulder Pain
- Keywords
- shoulder pain, suprascapular nerve, radiofrequency, central sensitization, neuropatic pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gülçin BabaoğluUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 4 Mar 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.
Chronic shoulder pain affects quality of life and is often associated with central sensitization, leading to treatment resistance. Pulsed radiofrequency (PRF) of the suprascapular nerve, which innervates 70% of the shoulder joint, is a promising therapy for nociceptive and neuropathic pain. This study evaluates the effects of PRF on central sensitization and neuropathic pain in chronic shoulder pain. Clinical assessments will be conducted at baseline, 1 month, and 3 months post-treatment to determine PRF's potential in reducing central sensitization and improving shoulder function.
Detailed description
Chronic shoulder pain is a prevalent musculoskeletal condition affecting quality of life, with an incidence of 18-26% in the general population. Its prevalence has doubled over the past 40 years. Pain sensitization, independent of etiology, is frequently observed in patients with musculoskeletal shoulder pain and can lead to poorer clinical outcomes even after primary disease treatment. Chronic pain development involves both peripheral and central sensitization mechanisms, with central sensitization characterized by amplified pain signaling and reduced inhibitory pathway activity. This can result in pain persistence independent of tissue damage and resistance to treatment.
Conventional treatments for chronic shoulder pain include physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and intra-articular steroid injections. However, these may not provide sufficient long-term analgesia, and some patients develop treatment-resistant chronic pain. Recently, pulsed radiofrequency (PRF) treatment applied to the suprascapular nerve, responsible for 70% of the sensory innervation of the shoulder joint, has gained attention for its efficacy in reducing both nociceptive and neuropathic pain. PRF modulates neural activity without causing thermal damage and may have the potential to reduce central sensitization. However, its effects on central sensitization and neuropathic pain mechanisms remain insufficiently studied.
This study aims to evaluate the impact of suprascapular nerve PRF on central sensitization and neuropathic pain in chronic shoulder pain. Clinical assessments will be conducted at baseline, 1 month, and 3 months post-treatment to examine changes in central sensitization, neuropathic pain, and shoulder function. This study seeks to determine whether PRF can serve as an effective alternative in chronic shoulder pain management by reducing central sensitization and improving quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suprascapular nerve pulsed radiofrequency | – | Procedure: pulsed radiofrequencypatients undergoing suprascapular nerve pulsed radiofrequency therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic shoulder pain persisting for at least 3 months
Key inclusion criteria (6 listed)
- Chronic shoulder pain persisting for at least 3 months
- Radiologically confirmed shoulder lesions, including:
- Rotator cuff tendinopathy Adhesive capsulitis Bursitis Osteoarthritis
- At least two positive provocation tests (Neer, Hawkins, Jobe tests)
- Shoulder pain resistant to conservative treatments, including:
Key exclusion criteria (7 listed)
- Traumatic shoulder pain (e.g., fractures, dislocations)
- History of shoulder surgery
- Active inflammation or rheumatic diseases affecting the shoulder, including:
- Rheumatoid arthritis Polymyalgia rheumatica Ankylosing spondylitis
- Cervical radiculopathy
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 radiofrequencyAll patients will be monitored with electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation, and peripheral intravenous vascular access will be performed before the procedure. Patients will be placed in a sitting position. The physician will stand behind the patient for the posterior approach. The skin area to be injected will be prepared and covered in a sterile manner using a povidone-iodine-based solution. The operator will use ultrasound (a TOSHIBA Aplio 500 Ultrasound) guidance to perform suprascapular nerve radiofrequency. The suprascapular notch will be visualized. A twenty-two gauge, 10 cm long, and 10 mm active-tipped radiofrequency cannula will be introduced to the suprascapular notch. Motor stimulation will be performed at 2 Hz at a setting of 1 V, and sensory stimulation will be performed at 50 Hz at a setting of 0.5 V. After the needle tip confirmation, pulsed radiofrequency will be applied to the suprascapular nerve for 360 seconds. | Procedure or surgery | suprascapular nerve pulsed radiofrequency |
Primary outcome
Central Sensitization Inventory (CSI)
Time frame: baseline, 1st and 3rd months
The CSI will be used to assess symptoms related to CS. The CSI will consist of two parts, Part A and Part B. Part A will include 25 items scored on a scale from 0 to 100, with higher scores indicating an increased CS-related symptom burden. In Part B, diagnoses of central sensitivity syndromes will be questioned, and this part will not be included in the scoring.
3 secondary outcomes
Douleur Neuropathique 4 (DN4) Questionnaire
Time frame: baseline, 1st and 3rd months
Numerical Rating Scale (NRS)
Time frame: baseline, 1st and 3rd months
Shoulder Pain and Disability Index (SPADI)
Time frame: baseline, 1st and 3rd months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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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.
ERKAN YAVUZ AKÇABOY, Prof. Dr. principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by Gülçin Babaoğlu 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Central Sensitization Inventory (CSI) (time frame: baseline, 1st and 3rd months). 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 8 May 2026.