Capsulitis, AdhesivepainNCT07088562
Evaluation of the Effectiveness of Ultrasonography-Guided Pulsed Radiofrequency to the Suprascapular Nerve in the Treatment of Adhesive Capsulitis in Elderly Patients
An observational study of Capsulitis, Adhesive and Pulsed Radiofrequency, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Adhesive Capsulitis (AC) is a condition that restricts the passive and active range of motion of the shoulder joint, impairing quality of life and activities. AC, which can be progressive and last a long time, is also called "frozen shoulder." The incidence of AC is 2-4% in the normal patient population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Capsulitis, Adhesive, Pulsed Radiofrequency, Eldery People
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 15 Aug 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over the age of 65 who met the AK diagnostic criteria through clinical, radiological (MRI) and physical examination between June 2022 and June 2023, and who received SS-PRF treatment and who could not achieve adequate pain palliation despite medical and physical therapy modalities within an appropriate period of time, will be retrospectively screened.
Who may be able to join
- Patients over the age of 65 who were diagnosed with adhesive capsulitis through clinical physical examination and imaging and who underwent shoulder SS-PRF.
- Patients with complete data to be scanned in their files.
Who cannot join
- Patients with a history of shoulder surgery,
- shoulder impingement syndrome, osteoarthritis, or other primary shoulder pathologies that could explain shoulder pain,
- patients who received shoulder injections within the last 3 months,
- patients with psychosis,
- patients with pacemakers (ICDs), patients with decompensated chronic diseases,
- patients with bleeding disorders,
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- patients with active malignancy or infection,
- patients with advanced cervical disc herniation,
- patients with allergies to the medications to be administered,
- patients who could not be communicated with, and patients who did not accept the procedure were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İKanuni Sultan Süleyman Training and Research Hospital
Küçükçekmece, Istanbul, (507) 277-4773
About this study
Adhesive Capsulitis (AC) is a condition that restricts the passive and active range of motion of the shoulder joint, impairing quality of life and activities. AC, which can be progressive and last a long time, is also called "frozen shoulder." The incidence of AC is 2-4% in the normal patient population. This rate varies between 10-30% in diabetic patients. The limitation and pain in AC joint range of motion (ROM) can last up to 3 years. There is no clear data on its prevalence in elderly patients. Its etiopathogenesis has not been fully elucidated. Fibrotic contractures form in the joint capsule. Diabetes, female gender, autoimmune diseases, thyroid disorders, immobilization, cardiovascular and cerebrovascular diseases, and advanced age are among the risk factors . AC is often diagnosed by physical examination and exclusion of other joint pathologies. Magnetic resonance imaging (MRI) can be helpful in diagnosis .
Physical therapy, medical, interventional methods, and surgery are used in the treatment of AC. In physical therapy, exercises and modalities aimed at increasing ROM are used, while medical treatment includes oral analgesics, myorelaxants, and topical analgesics. Effective treatment options include intra-articular steroid injections and radiofrequency applications for blocking the suprascapular nerve (SN). The SN originates from the ventral branches of the C5-C6 brachial plexus. It is responsible for 70% of the shoulder innervation, particularly to the shoulder joint and capsule, and the acromioclavicular joint (ACJ). It provides motor innervation to the supraspinatus and infraspinatus muscles. NS block or radiofrequency applications are frequently used in the treatment of pain in shoulder joint pathologies, impingement syndrome, and ACJ pathologies. Previously, conventional radiofrequency applied at high temperatures had destructive effects on the nerve. While conventional methods are currently used in some cases, pulsed radiofrequency is effectively applied at lower temperatures, particularly to prevent motor damage .
In this study, we aimed to present the effectiveness of pulsed radiofrequency (SS-PRF) application to the suprascapular nerve in a difficult and challenging patient group (elderly patients) in AC, a difficult disease to treat.
Read the detailed description
Patients over the age of 65 who met the diagnostic criteria for AC based on clinical, radiological (MRI), and physical examination between June 2022 and June 2023, but who failed to achieve adequate pain palliation despite appropriate medical and physical therapy modalities, and who underwent SS-PRF treatment will be retrospectively reviewed. Data from the patient files will be recorded for age, gender, body mass index (BMI), symptom duration, affected side, and the presence of concomitant diabetes. Procedure: Under appropriate monitoring conditions, patients who benefited >50% from the diagnostic block received a single session of SS-PRF at 420°C (45 V, 20 ms) for 240 seconds in a semi-sitting position under ultrasound guidance after obtaining responses from the suprascapular notch with a 100 mm-long, 10 mm active-tip radiofrequency needle.
Patients whose data can be accessed through their files will have their age, gender, body mass index (BMI), symptom duration, painful side, and medical treatments recorded. Activity and Rest Numerical Rating Scale (NRS-11) and Shoulder Pain and Disability Index (SPADI) scores will be recorded before and after treatment, at weeks 4 and 12.
The NRS-11 is an 11-point numerical scale that allows patients to rate their pain from 0 (no pain) to 10 (the most severe pain they have ever experienced).
The SPADI is a validated index consisting of 13 questions, 5 assessing pain and 8 assessing disability, and scored from 0 to 100 to assess shoulder pain and functionality. Higher scores indicate greater pain and disability.
- Medical subject headings
- Bursitis
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 |
|---|---|---|
| Evaluation of the Effectiveness of Ultrasonography-Guided Pulsed Radiofrequency to the Suprascapular | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale (NRS-11)
The NRS-11 is an 11-point numerical scale on which patients can rate their pain from 0 (no pain at all) to 10 (the most severe pain they have ever felt).
Measured: 12 weeks
shoulder pain and disability index (SPADI)
The SPADI is a validated index consisting of 13 questions, 5 of which assess pain and 8 assess disability, and is scored from 0 to 100 to assess shoulder pain and functionality. As the score increases, pain and disability increase.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsulitis, AdhesiveStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 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
- halil ibrahim altun, Principal investigator, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088562
- Sponsor's protocol ID
- Radiofrequency, shoulder pain
- Acronym
- pain
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2025
- Last updated
- 23 Sep 2025
- Results posted
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Ultrasonography-Guided Pulsed Radiofrequency to the Suprascapular Nerve in the Treatment of Adhesive Capsulitis in Elderly Patients
- ClinicalTrials.gov ID
- NCT07088562
- Acronym / sponsor ID
- pain / Radiofrequency, shoulder pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 28 Jul 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.
Adhesive Capsulitis (AC) is a condition that restricts the passive and active range of motion of the shoulder joint, impairing quality of life and activities. AC, which can be progressive and last a long time, is also called "frozen shoulder." The incidence of AC is 2-4% in the normal patient population. This rate varies between 10-30% in diabetic patients. The limitation and pain in AC joint range of motion (ROM) can last up to 3 years. There is no clear data on its prevalence in elderly patients. Its etiopathogenesis has not been fully elucidated. Fibrotic contractures form in the joint capsule. Diabetes, female gender, autoimmune diseases, thyroid disorders, immobilization, cardiovascular and cerebrovascular diseases, and advanced age are among the risk factors . AC is often diagnosed by physical examination and exclusion of other joint pathologies. Magnetic resonance imaging (MRI) can be helpful in diagnosis .
Physical therapy, medical, interventional methods, and surgery are used in the treatment of AC. In physical therapy, exercises and modalities aimed at increasing ROM are used, while medical treatment includes oral analgesics, myorelaxants, and topical analgesics. Effective treatment options include intra-articular steroid injections and radiofrequency applications for blocking the suprascapular nerve (SN). The SN originates from the ventral branches of the C5-C6 brachial plexus. It is responsible for 70% of the shoulder innervation, particularly to the shoulder joint and capsule, and the acromioclavicular joint (ACJ). It provides motor innervation to the supraspinatus and infraspinatus muscles. NS block or radiofrequency applications are frequently used in the treatment of pain in shoulder joint pathologies, impingement syndrome, and ACJ pathologies. Previously, conventional radiofrequency applied at high temperatures had destructive effects on the nerve. While conventional methods are currently used in some cases, pulsed radiofrequency is effectively applied at lower temperatures, particularly to prevent motor damage .
In this study, we aimed to present the effectiveness of pulsed radiofrequency (SS-PRF) application to the suprascapular nerve in a difficult and challenging patient group (elderly patients) in AC, a difficult disease to treat.
Detailed description
Patients over the age of 65 who met the diagnostic criteria for AC based on clinical, radiological (MRI), and physical examination between June 2022 and June 2023, but who failed to achieve adequate pain palliation despite appropriate medical and physical therapy modalities, and who underwent SS-PRF treatment will be retrospectively reviewed. Data from the patient files will be recorded for age, gender, body mass index (BMI), symptom duration, affected side, and the presence of concomitant diabetes. Procedure: Under appropriate monitoring conditions, patients who benefited >50% from the diagnostic block received a single session of SS-PRF at 420°C (45 V, 20 ms) for 240 seconds in a semi-sitting position under ultrasound guidance after obtaining responses from the suprascapular notch with a 100 mm-long, 10 mm active-tip radiofrequency needle.
Patients whose data can be accessed through their files will have their age, gender, body mass index (BMI), symptom duration, painful side, and medical treatments recorded. Activity and Rest Numerical Rating Scale (NRS-11) and Shoulder Pain and Disability Index (SPADI) scores will be recorded before and after treatment, at weeks 4 and 12.
The NRS-11 is an 11-point numerical scale that allows patients to rate their pain from 0 (no pain) to 10 (the most severe pain they have ever experienced).
The SPADI is a validated index consisting of 13 questions, 5 assessing pain and 8 assessing disability, and scored from 0 to 100 to assess shoulder pain and functionality. Higher scores indicate greater pain and disability.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the Effectiveness of Ultrasonography-Guided Pulsed Radiofrequency to the Suprascapular | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over the age of 65 who met the AK diagnostic criteria through clinical, radiological (MRI) and physical examination between June 2022 and June 2023, and who received SS-PRF treatment and who could not achieve adequate pain palliation despite medical and physical therapy modalities within an appropriate period of time, will be retrospectively screened.
Key inclusion criteria (2 listed)
- Patients over the age of 65 who were diagnosed with adhesive capsulitis through clinical physical examination and imaging and who underwent shoulder SS-PRF.
- Patients with complete data to be scanned in their files.
Key exclusion criteria (10 listed)
- Patients with a history of shoulder surgery,
- shoulder impingement syndrome, osteoarthritis, or other primary shoulder pathologies that could explain shoulder pain,
- patients who received shoulder injections within the last 3 months,
- patients with psychosis,
- patients with pacemakers (ICDs), patients with decompensated chronic diseases,
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
numerical rating scale (NRS-11)
Time frame: 12 weeks
The NRS-11 is an 11-point numerical scale on which patients can rate their pain from 0 (no pain at all) to 10 (the most severe pain they have ever felt).
shoulder pain and disability index (SPADI)
Time frame: 12 weeks
The SPADI is a validated index consisting of 13 questions, 5 of which assess pain and 8 assess disability, and is scored from 0 to 100 to assess shoulder pain and functionality. As the score increases, pain and disability increase.
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 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
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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.
halil ibrahim altun principal investigator
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 Capsulitis, Adhesive and Pulsed Radiofrequency, 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 10 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 23 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?
numerical rating scale (NRS-11) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 23 Sep 2025.