Shoulder Pain ChronicpainNCT06852781
Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapular Nerve Under Ultrasonography Guided in Shoulder Pain
An observational study of Shoulder Pain Chronic and Neuromodulation, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Shoulder pain is a musculoskeletal system (MSS) disease that is frequently seen in adults and tends to become chronic. It ranks 3rd among MSS diseases after low back and knee pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain Chronic, Neuromodulation, Ultrasound Guided
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Patients over the age of 18 who have pain at or above visual analog scale (VAS) 4 despite pharmacological agents and physical therapy (passive range of motion, strengthening exercises) for more than 3 months and who meet the inclusion criteria will be included in the study.
Who may be able to join
- Patients over the age of 18 who have pain at or above visual analog scale (VAS) 4 despite pharmacological agents and physical therapy (passive range of motion, strengthening exercises) for more than 3 months and who meet the inclusion criteria will be included in the study.
- Patients with complete data to be scanned in their files
Who cannot join
- Patients with known malignancy,
- patients who had shoulder injections within the last 3 months,
- patients who changed their medical analgesic treatment or underwent surgery during follow-up,
- patients with previous shoulder surgery or deformity,
- patients with inflammatory arthritis and fibromyalgia,
- patients with known cervical disc herniation,
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- patients with pacemakers, pregnant women,
- patients with chronic decompensated disease,
- hemiplegic patients,
- patients with major psychopathology,
- patients allergic to medications used during the procedure,
- patients with infection in the procedure area,
- patients with bleeding disorders, and patients who did not agree to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Turkey, 34000
About this study
Shoulder pain is a musculoskeletal system (MSS) disease that is frequently seen in adults and tends to become chronic. It ranks 3rd among MSS diseases after low back and knee pain. The main causes of shoulder pain are compression syndromes, acromioclavicular (AC) and glenohumeral joint degeneration, adhesive capsulitis, and biceps tendinopathy. Pathology may be in the joint, bone, muscle, tendon ligament, or bursa. Pain restricts the passive and active range of motion of the shoulder joint, impairing the quality of daily life and activity. It is thought to be between 20% and 50% in the adult population in a 1-year period, and its lifetime prevalence is approximately 10%. Central sensitization develops in cases where the pain is progressive and becomes chronic over time. It has been observed that it becomes chronic in more than 40% of patients in a 1-year period. Thus, shoulder pain becomes a biopsychosocial disease over time.
Physical therapy, medical, interventional methods, and surgery are applied in the treatment of shoulder pain. In physical therapy, exercises and some physical medicine modalities are applied to increase joint range of motion and reduce pain, while in medical treatment, oral analgesics, myorelaxants, and topical analgesics are used. Interventional intra-articular steroid injections and distal suprascapular nerve (SS) blockade radiofrequency applications are among the effective treatment options.
Read the detailed description
Patients over the age of 18 who have had chronic shoulder pain for more than 3 months, who could not achieve adequate pain palliation despite appropriate medical and physical therapy modalities, and who were treated with SS-PRF between June 2023 and June 2024 with clinical, radiological (MR) and physical examination will be retrospectively screened. The patients whose data can be accessed from the patient file will be recorded for age, gender, body mass index (BMI), duration of symptoms, painful side, pain etiology (subacromial bursitis, impingement syndrome, acromioclavicular degeneration, biceps tendonitis, labral pathologies, shoulder osteoarthritis, etc.), paracetamol dose, and procedure time. Procedure; The patient was taken to the procedure room, monitored [5-lead electrocardiogram (ECG), pulse oximetry, and noninvasive blood pressure], and a vascular access was established in the forearm. After obtaining appropriate sensory and motor responses with a 22 G 100 mm needle and nerve stimulator under ultrasonography guidance, a negative aspiration 5 ml 0.25% bupivacaine diagnostic block was performed with the patient in a semi-sitting position under sterile conditions. In patients who benefited 50% or more from the diagnostic block, a single session of 180 sec, 420 (2 Hz frequency, 45 V, 20 ms) SS-PRF was applied to patients who benefited 50% or more from the diagnostic block with a 100 mm long, 5 mm active tip radiofrequency needle under ultrasonography guidance in a semi-sitting position after obtaining appropriate responses from the suprascapular or spinoglenoid notch (shoulder external rotation and/or abduction).
Geri bildirim gönder Yan paneller Geçmiş Kaydedilenler
- Conditions
- Shoulder Pain Chronic, Neuromodulation, Ultrasound Guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapul | Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapular Nerve under Ultrasonography Guided in Shoulder Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity visual analogue scale (VAS)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Pain ChronicStudies 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- altun, Study director, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852781
- Sponsor's protocol ID
- neuromodulation,shoulder pain
- Acronym
- pain
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapular Nerve Under Ultrasonography Guided in Shoulder Pain
- ClinicalTrials.gov ID
- NCT06852781
- Acronym / sponsor ID
- pain / neuromodulation,shoulder pain
- Conditions
- Shoulder Pain Chronic, Neuromodulation, Ultrasound Guided
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 28 Feb 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.
Shoulder pain is a musculoskeletal system (MSS) disease that is frequently seen in adults and tends to become chronic. It ranks 3rd among MSS diseases after low back and knee pain. The main causes of shoulder pain are compression syndromes, acromioclavicular (AC) and glenohumeral joint degeneration, adhesive capsulitis, and biceps tendinopathy. Pathology may be in the joint, bone, muscle, tendon ligament, or bursa. Pain restricts the passive and active range of motion of the shoulder joint, impairing the quality of daily life and activity. It is thought to be between 20% and 50% in the adult population in a 1-year period, and its lifetime prevalence is approximately 10%. Central sensitization develops in cases where the pain is progressive and becomes chronic over time. It has been observed that it becomes chronic in more than 40% of patients in a 1-year period. Thus, shoulder pain becomes a biopsychosocial disease over time.
Physical therapy, medical, interventional methods, and surgery are applied in the treatment of shoulder pain. In physical therapy, exercises and some physical medicine modalities are applied to increase joint range of motion and reduce pain, while in medical treatment, oral analgesics, myorelaxants, and topical analgesics are used. Interventional intra-articular steroid injections and distal suprascapular nerve (SS) blockade radiofrequency applications are among the effective treatment options.
Detailed description
Patients over the age of 18 who have had chronic shoulder pain for more than 3 months, who could not achieve adequate pain palliation despite appropriate medical and physical therapy modalities, and who were treated with SS-PRF between June 2023 and June 2024 with clinical, radiological (MR) and physical examination will be retrospectively screened. The patients whose data can be accessed from the patient file will be recorded for age, gender, body mass index (BMI), duration of symptoms, painful side, pain etiology (subacromial bursitis, impingement syndrome, acromioclavicular degeneration, biceps tendonitis, labral pathologies, shoulder osteoarthritis, etc.), paracetamol dose, and procedure time. Procedure; The patient was taken to the procedure room, monitored [5-lead electrocardiogram (ECG), pulse oximetry, and noninvasive blood pressure], and a vascular access was established in the forearm. After obtaining appropriate sensory and motor responses with a 22 G 100 mm needle and nerve stimulator under ultrasonography guidance, a negative aspiration 5 ml 0.25% bupivacaine diagnostic block was performed with the patient in a semi-sitting position under sterile conditions. In patients who benefited 50% or more from the diagnostic block, a single session of 180 sec, 420 (2 Hz frequency, 45 V, 20 ms) SS-PRF was applied to patients who benefited 50% or more from the diagnostic block with a 100 mm long, 5 mm active tip radiofrequency needle under ultrasonography guidance in a semi-sitting position after obtaining appropriate responses from the suprascapular or spinoglenoid notch (shoulder external rotation and/or abduction).
Geri bildirim gönder Yan paneller Geçmiş Kaydedilenler
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapul | – | –Comparison of Spinoglenoid and Suprascapular Notch Approaches and Neuromodulation of the Suprascapular Nerve under Ultrasonography Guided in Shoulder Pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients over the age of 18 who have pain at or above visual analog scale (VAS) 4 despite pharmacological agents and physical therapy (passive range of motion, strengthening exercises) for more than 3 months and who meet the inclusion criteria will be included in the study.
Key inclusion criteria (2 listed)
- Patients over the age of 18 who have pain at or above visual analog scale (VAS) 4 despite pharmacological agents and physical therapy (passive range of motion, strengthening exercises) for more than 3 months and who meet the inclusion criteria will be included in the study.
- Patients with complete data to be scanned in their files
Key exclusion criteria (13 listed)
- Patients with known malignancy,
- patients who had shoulder injections within the last 3 months,
- patients who changed their medical analgesic treatment or underwent surgery during follow-up,
- patients with previous shoulder surgery or deformity,
- patients with inflammatory arthritis and fibromyalgia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Activity visual analogue scale (VAS)
Time frame: one year
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 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
altun study director
Kanuni Sultan Süleyman 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?
An observational study of Shoulder Pain Chronic and Neuromodulation, run by Kanuni Sultan Suleyman Training and Research Hospital 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 13 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 19 Sep 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?
Activity visual analogue scale (VAS) (time frame: one year). 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 19 Sep 2025.