Suprascapular NerveNCT06713005
The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency
A study testing suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve and suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve in people with Suprascapular Nerve and Shoulder Impingement Syndrome, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Chronic shoulder pain due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Suprascapular Nerve, Shoulder Impingement Syndrome, Pulsed Radiofrequency
- What is being tested?
- suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve and suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jul 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years
- Shoulder pain caused by impingement syndrome
- Shoulder pain due to supraspinatus tendinosis
- Diagnosis of impingement syndrome and supraspinatus tendinosis confirmed through physical examination and radiological imaging (MRI)
- Pain persisting for 3 months or longer
- Numeric Pain Rating Scale (NRS) score of 4 or higher despite conservative treatment
Who cannot join
- Patients unwilling to participate in the study
- Presence of chronic pain due to other conditions
- Presence of cervical radiculopathy
- History of opioid use
- Uncontrolled diabetes (HbA1c > 8)
- History of shoulder surgery on the affected side
Show all 9Show fewer
- Uncontrolled psychiatric disorders despite medical treatment
- History of cancer
- History of stroke
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency Treatment in Chronic Soulder Pain
Chronic shoulder pain due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. To prolong analgesia, short bursts of electrical stimulation to suprascapular nerve may be applied. To the date there is no consensus about duration of these type of stimulation. Investigators' aim is to investigate efficacy of two different duration of stimulation (pulsed radiofrequency) on chronic shoulder pain.
Read the detailed description
Pulsed radiofrequency (pRF) treatment of suprascapular nerve can be used successfully to alleviate pain due to shoulder impingement syndrome and supraspinatus tendinosis. Radiofrequency waves produced by radiofrequency (RF) generator through pRF modality are applied to suprascapular nerve and create magnetic field. This field leads to pain modulation by changing neuronal activity and resulting in long term depression of pain transmitting nerve fibers. Temperature around nerve never exceeds 42 degree and by this way the nerve can be protected from coagulation necrosis and demiyelinisation. pRF can be used in the treatment of mixed type nerves such as suprascapular nerve. There are preclinical and clinical studies which report that with longer pRF duration, more favorable analgesia. Suprascapular pRF is performed with 22G, 10 cm, 5 mm active lead RF needle via USG guided posterior approach as institution procotol. Howeveri clinicians can choose any duration of pRF. Instution's pain medicine practitioners HAU and GEO choose 4 and 9 minutes of pRF duration, respectively. Investigators' aim is to investigate the efficacy of two different pRF duration, 4 and 9 minutes, on Shoulder Pain and Disability Index (SPADI) and Numeric Rating Scale-11(NRS-11) at 3 month follow-up.
- Conditions
- Suprascapular Nerve, Shoulder Impingement Syndrome, Pulsed Radiofrequency, Chronic Pain, Supraspinatus Tendinopathy
- Being tested
- suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve, suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve
- Keywords
- pulsed radiofrequency, suprascapular nerve, chronic pain, impingement syndrome, Supraspinatus tendinopathy
- Medical subject headings
- Shoulder Impingement Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerveProcedure or surgery
suprascapular nerve pulsed rf
suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerveProcedure or surgery
suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve
| Study group | Role | What they receive |
|---|---|---|
| 4 min suprascapular pulsed RF | Other | Suprascapular nerve pulsed RF is applied for 4 minutes. Receives: Procedure: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve |
| 9 min suprascapular pulsed RF | Other | Suprascapular nerve pulsed RF is applied for 8 minutes. Receives: Procedure: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprocedure 3th month pain severity
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at baseline, 1 weeks, 1 months and 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Measured: From procedure to 3 months after prodecure
Secondary outcomes (5)
Postprocedure pain severity at first week
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 week after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Measured: From procedure to 1 week after procedure
Postprocedure first month pain severity
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 month after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
Measured: From procedure to 1 month after procedure
Postprocedure SPADI scores at first week
Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 1 week. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.
Measured: From procedure to 1 week after procedure
Postprocedure first month SPADI scores
Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 1 month. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.
Measured: From procedure to 1 month after procedure
Postprocedure 3th month SPADI scores
Functionality will be assessed with Shoulder Pain and Disability Index (SPADI) at 3th month. SPADI measures pain and disability related shoulder function. SPADI has 0 minimum and 100 maximum value. Lower scores represent better outcomes.
Measured: From procedure to 3 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suprascapular NerveStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: 4 mins suprascapular pulsed RF Group 2: 9 mins suprascapular pulsed RF
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanzade Aybuke Unal, Ankara University
- Investigators
- Güngör Enver Özgencil, Prof Dr, Study director, Ankara University School of Medicine Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713005
- Sponsor's protocol ID
- 2024/765
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data can be shared except personal data.
Publications
Gupta SK, Ghai B, Makkar JK, Dhiman D, Chouhan DK. Effectiveness of ultrasound-guided pulsed radiofrequency ablation of suprascapular nerve versus local anaesthetics with steroids in patients with chronic shoulder pain: A randomised controlled trial. Indian J Anaesth. 2024 Aug;68(8):731-734. doi: 10.4103/ija.ija_939_23. Epub 2024 Jul 2. No abstract available.
PubMed 39176114
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency Treatment in Chronic Soulder Pain
- ClinicalTrials.gov ID
- NCT06713005
- Acronym / sponsor ID
- 2024/765
- Conditions
- Suprascapular Nerve, Shoulder Impingement Syndrome, Pulsed Radiofrequency, Chronic Pain, Supraspinatus Tendinopathy
- Keywords
- pulsed radiofrequency, suprascapular nerve, chronic pain, impingement syndrome, Supraspinatus tendinopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 Dec 2024 (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 due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. To prolong analgesia, short bursts of electrical stimulation to suprascapular nerve may be applied. To the date there is no consensus about duration of these type of stimulation. Investigators' aim is to investigate efficacy of two different duration of stimulation (pulsed radiofrequency) on chronic shoulder pain.
Detailed description
Pulsed radiofrequency (pRF) treatment of suprascapular nerve can be used successfully to alleviate pain due to shoulder impingement syndrome and supraspinatus tendinosis. Radiofrequency waves produced by radiofrequency (RF) generator through pRF modality are applied to suprascapular nerve and create magnetic field. This field leads to pain modulation by changing neuronal activity and resulting in long term depression of pain transmitting nerve fibers. Temperature around nerve never exceeds 42 degree and by this way the nerve can be protected from coagulation necrosis and demiyelinisation. pRF can be used in the treatment of mixed type nerves such as suprascapular nerve. There are preclinical and clinical studies which report that with longer pRF duration, more favorable analgesia. Suprascapular pRF is performed with 22G, 10 cm, 5 mm active lead RF needle via USG guided posterior approach as institution procotol. Howeveri clinicians can choose any duration of pRF. Instution's pain medicine practitioners HAU and GEO choose 4 and 9 minutes of pRF duration, respectively. Investigators' aim is to investigate the efficacy of two different pRF duration, 4 and 9 minutes, on Shoulder Pain and Disability Index (SPADI) and Numeric Rating Scale-11(NRS-11) at 3 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: 4 mins suprascapular pulsed RF Group 2: 9 mins suprascapular pulsed RF
| Arm | Type | Receives |
|---|---|---|
| 4 min suprascapular pulsed RF | Other | Procedure: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerveSuprascapular nerve pulsed RF is applied for 4 minutes. |
| 9 min suprascapular pulsed RF | Other | Procedure: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerveSuprascapular nerve pulsed RF is applied for 8 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-80 years
- Shoulder pain caused by impingement syndrome
- Shoulder pain due to supraspinatus tendinosis
- Diagnosis of impingement syndrome and supraspinatus tendinosis confirmed through physical examination and radiological imaging (MRI)
- Pain persisting for 3 months or longer
Key exclusion criteria (9 listed)
- Patients unwilling to participate in the study
- Presence of chronic pain due to other conditions
- Presence of cervical radiculopathy
- History of opioid use
- Uncontrolled diabetes (HbA1c > 8)
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 |
|---|---|---|
| suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nervesuprascapular nerve pulsed rf | Procedure or surgery | 4 min suprascapular pulsed RF |
| suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nervesuprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve | Procedure or surgery | 9 min suprascapular pulsed RF |
Primary outcome
Postprocedure 3th month pain severity
Time frame: From procedure to 3 months after prodecure
Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at baseline, 1 weeks, 1 months and 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.
5 secondary outcomes
Postprocedure pain severity at first week
Time frame: From procedure to 1 week after procedure
Postprocedure first month pain severity
Time frame: From procedure to 1 month after procedure
Postprocedure SPADI scores at first week
Time frame: From procedure to 1 week after procedure
Postprocedure first month SPADI scores
Time frame: From procedure to 1 month after procedure
Postprocedure 3th month SPADI scores
Time frame: From procedure to 3 month after procedure
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 27 Dec 2024.
- Background: PubMed 39176114Gupta SK, Ghai B, Makkar JK, Dhiman D, Chouhan DK. Effectiveness of ultrasound-guided pulsed radiofrequency ablation of suprascapular nerve versus local anaesthetics with steroids in patients with chronic shoulder pain: A randomised controlled trial. Indian J Anaesth. 2024 Aug;68(8):731-734. doi: 10.4103/ija.ija_939_23. Epub 2024 Jul 2. No abstract available.
- Individual participant dataSharing planned: Yes. All data can be shared except personal data.
Related trials for Suprascapular Nerve
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.
Rotator Cuff Tear, Pain Management
Not yet recruiting
Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy
Postoperative Pain, Hemidiaphragmatic Paresis
Recruiting
Anterior Suprascapular Versus Interscalene Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery in the Outpatient Setting
Postoperative Pain, Acute
RecruitingPhase 2/3
Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.
Nerve Block/Methods
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.
Güngör Enver Özgencil, Prof Dr study director
Ankara University School of Medicine Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve and suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve in people with Suprascapular Nerve and Shoulder Impingement Syndrome, run by Ankara University 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 9 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: opening soon, as of the sponsor's last update on 27 Dec 2024. 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?
Contact Hanzade Aybuke Unal, MD (+905057179039, hanzadeunal@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprocedure 3th month pain severity (time frame: From procedure to 3 months after prodecure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713005, which also lists 1 linked publication.
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 27 Dec 2024.