Chronic Shoulder PainNCT07607691
Ultrasound-Guided PENG Block for Chronic Shoulder Pain
A study testing Lidocaine and Dexamethasone for PENG Block in people with Chronic Shoulder Pain and Pericapsular Nerve Group Block (PENG Block), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this prospective, observational study is to evaluate the clinical and functional outcomes of ultrasound-guided Pericapsular Nerve Group (PENG) block in patients suffering from chronic shoulder pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Shoulder Pain, Pericapsular Nerve Group Block (PENG Block), Frozen Shoulder
- What is being tested?
- Lidocaine and Dexamethasone for PENG Block
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 15 Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Patients presenting with chronic shoulder pain lasting longer than 3 months.
- Initial pain intensity score greater than 4 on the Numerical Rating Scale (NRS > 4).
- Patients who have not responded to conservative or medical treatments.
- Voluntary acceptance of the ultrasound-guided shoulder PENG block treatment and compliance with the scheduled follow-up protocol.
Who cannot join
- Patients currently using anticoagulants or diagnosed with coagulation disorders (bleeding diathesis).
- Patients with psychomotor or cognitive disorders that prevent cooperative evaluation.
- Presence of active bacterial infection, open wounds, or infectious discharge at the planned needle injection site.
- History of shoulder surgery at the intervention site within the last 6 months.
- Known allergy or hypersensitivity to local anesthetics (lidocaine) or corticosteroids (dexamethasone).
- Pregnant or breastfeeding patients.
- Patients who reject the procedure or fail to comply with the scheduled follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, çankaya, 06810
ali çoştu, md, +905427669038, alicostu@gmail.com
About this study
Official title: Evaluation of the Analgesic Efficacy and Functional Outcomes of Ultrasound-Guided PENG Block in Chronic Shoulder Pain
The purpose of this prospective, observational study is to evaluate the clinical and functional outcomes of ultrasound-guided Pericapsular Nerve Group (PENG) block in patients suffering from chronic shoulder pain. Chronic shoulder pain is a highly prevalent musculoskeletal problem that significantly restricts daily activities and diminishes the patient's quality of life. While conservative treatments and various interventional injections are widely used, long-term efficacy can be limited, and systemic side effects may occur. The shoulder PENG block is a novel regional analgesia technique that specifically targets the articular (sensory) branches of the nerves innervating the shoulder joint capsule without affecting the motor branches. In this single-center study, a total of 45 eligible adult patients with chronic shoulder pain who did not respond to conservative medical treatments will receive an ultrasound-guided PENG block as part of their routine clinical care. The procedure will be performed under sterile conditions using a combination of local anesthetic (lidocaine) and dexamethasone. Patient pain levels will be assessed using the Numerical Rating Scale (NRS), shoulder disability and functional status will be measured using the Shoulder Pain and Disability Index (SPADI), and overall patient satisfaction will be evaluated using the Global Perceived Effect (GPE) score. All parameters will be documented at baseline (before the procedure) and at follow-up visits on the 1st week, 4th week (1 month), and 3rd month post-procedure. The investigators aim to determine the efficacy, duration of effect, and safety profile of this intervention.
Read the detailed description
Study Design and Setting:
This is a prospective, observational, and single-center clinical study designed to evaluate the clinical and functional outcomes of ultrasound-guided Pericapsular Nerve Group (PENG) block in patients with chronic shoulder pain. The study will be conducted in accordance with the Declaration of Helsinki, and approval from the local clinical research ethics committee will be obtained prior to patient enrollment.
Patient Selection:
Adult patients (aged over 18 years) presenting with chronic shoulder pain lasting longer than 3 months, who have an initial Numerical Rating Scale (NRS) score greater than 4 and have not responded to conservative or medical treatments, will be screened for eligibility. Written informed consent will be obtained from all participating individuals. Patients with coagulation disorders, psychomotor disorders, active infections at the injection site, a history of shoulder surgery within the past 6 months, or known allergies to local anesthetics or corticosteroids will be excluded.
Intervention Protocol:
The ultrasound-guided shoulder PENG block is performed as a routine treatment modality in our clinic for patients non-responsive to conservative therapies. The procedure is conducted under sterile conditions with the patient in the supine position. The affected shoulder is placed in abduction and external rotation. An ultrasound transducer is positioned parallel to the clavicle to visualize the anatomical structures. A block needle is advanced under the subscapularis muscle under direct ultrasound guidance. Following the confirmation of correct needle positioning, a mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is injected into the periarticular nerve endpoints. Outcome Measurements and Data Collection:
Demographic and clinical data will be collected by an expert algologist using the hospital information management system and recorded into dedicated study forms. Clinical parameters will be evaluated at four distinct time points: baseline (pre-procedure), 1st week, 4th week (1 month), and 3rd month post-procedure. Pain severity will be measured using the Numerical Rating Scale (NRS). Shoulder joint function and disability levels will be assessed using the Shoulder Pain and Disability Index (SPADI). Overall patient satisfaction and perceived improvement will be tracked via the Global Perceived Effect (GPE) scale.
Friedman test, depending on the distribution properties. Bonferroni correction will be applied for post-hoc pairwise comparisons, and a p-value less than 0.05 will be considered statistically significant.
- Conditions
- Chronic Shoulder Pain, Pericapsular Nerve Group Block (PENG Block), Frozen Shoulder, Bursitis, Rotator Cuff Disorders
- Being tested
- Lidocaine and Dexamethasone for PENG Block
- Keywords
- shoulder pain, pericapsular nerve group block
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine and Dexamethasone for PENG BlockDrug
An ultrasound-guided Pericapsular Nerve Group (PENG) block is administered to target the articular (sensory) branches of the nerves innervating the shoulder joint capsule (suprascapular, axillary, and lateral pectoral nerves) without affecting the motor branches.
The intervention is performed under strict sterile conditions with the patient in the supine position. The affected shoulder is placed in abduction and external rotation. A high-frequency ultrasound transducer is positioned parallel to the clavicle to visualize the anatomical structures. Under direct ultrasound guidance, a block needle is advanced beneath the subscapularis muscle. After confirming the correct needle positioning and ensuring no intravascular placement, a therapeutic mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is injected into the periarticular nerve endpoints.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block Group | Experimental | Patients with chronic shoulder pain who receive an ultrasound-guided Pericapsular Nerve Group (PENG) block. Under sterile conditions and in the supine position, with the shoulder in abduction and external rotation, an ultrasound transducer is placed parallel to the clavicle. A block needle is advanced under the subscapularis muscle. Following confirmation of the needle position, a mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is administered to the periarticular nerve endpoints. Receives: Drug: Lidocaine and Dexamethasone for PENG Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Numerical Rating Scale (NRS) Score
The Numerical Rating Scale (NRS) is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The score ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst possible pain." Higher scores represent more severe pain intensity. Pain levels will be evaluated and compared across different time points
Measured: Baseline (pre-procedure), post-procedure 30th minute, 1st week, 4th week (1st month), and 12th week (3rd month)
Change from Baseline Shoulder Pain and Disability Index (SPADI) Score
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire used to measure shoulder pain and disability. It consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a visual analog scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it requires help). The total SPADI score is calculated by averaging the subscale scores and ranges from 0 to 100, where 0 indicates the best possible shoulder function (no pain and disability) and 100 indicates the worst possible shoulder function (severe pain and disability). Higher scores represent greater pain and disability
Measured: Baseline (pre-procedure), 1st week, 4th week (1st month), and 12th week (3rd month)
Secondary outcomes (1)
Global Perceived Effect (GPE) Score
The Global Perceived Effect (GPE) scale is a patient-reported outcome measure used to assess the patient's subjective perception of recovery or improvement since the beginning of the treatment. It is scored on a Likert-type scale (typically ranging from 1 to 7 or -5 to +5, with specific anchor points). For this study, a standard 7-point Likert scale will be used, where 1 indicates "extremely worsened", 4 indicates "no change", and 7 indicates "extremely improved". Higher scores represent a higher level of patient satisfaction and perceived clinical improvement.
Measured: Post-procedure 1st week, 4th week (1st month), and 12th week (3rd month).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Oct 2026 (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 Chronic Shoulder PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali ÇOŞTU, Ankara City Hospital Bilkent
- Investigators
- ali çoştu, md, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607691
- Sponsor's protocol ID
- E2-26-14592
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
PubMed 15163107
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy and Functional Outcomes of Ultrasound-Guided PENG Block in Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT07607691
- Acronym / sponsor ID
- E2-26-14592
- Conditions
- Chronic Shoulder Pain, Pericapsular Nerve Group Block (PENG Block), Frozen Shoulder, Bursitis, Rotator Cuff Disorders
- Keywords
- shoulder pain, pericapsular nerve group block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 26 May 2026 (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.
The purpose of this prospective, observational study is to evaluate the clinical and functional outcomes of ultrasound-guided Pericapsular Nerve Group (PENG) block in patients suffering from chronic shoulder pain. Chronic shoulder pain is a highly prevalent musculoskeletal problem that significantly restricts daily activities and diminishes the patient's quality of life. While conservative treatments and various interventional injections are widely used, long-term efficacy can be limited, and systemic side effects may occur. The shoulder PENG block is a novel regional analgesia technique that specifically targets the articular (sensory) branches of the nerves innervating the shoulder joint capsule without affecting the motor branches. In this single-center study, a total of 45 eligible adult patients with chronic shoulder pain who did not respond to conservative medical treatments will receive an ultrasound-guided PENG block as part of their routine clinical care. The procedure will be performed under sterile conditions using a combination of local anesthetic (lidocaine) and dexamethasone. Patient pain levels will be assessed using the Numerical Rating Scale (NRS), shoulder disability and functional status will be measured using the Shoulder Pain and Disability Index (SPADI), and overall patient satisfaction will be evaluated using the Global Perceived Effect (GPE) score. All parameters will be documented at baseline (before the procedure) and at follow-up visits on the 1st week, 4th week (1 month), and 3rd month post-procedure. The investigators aim to determine the efficacy, duration of effect, and safety profile of this intervention.
Detailed description
Study Design and Setting:
This is a prospective, observational, and single-center clinical study designed to evaluate the clinical and functional outcomes of ultrasound-guided Pericapsular Nerve Group (PENG) block in patients with chronic shoulder pain. The study will be conducted in accordance with the Declaration of Helsinki, and approval from the local clinical research ethics committee will be obtained prior to patient enrollment.
Patient Selection:
Adult patients (aged over 18 years) presenting with chronic shoulder pain lasting longer than 3 months, who have an initial Numerical Rating Scale (NRS) score greater than 4 and have not responded to conservative or medical treatments, will be screened for eligibility. Written informed consent will be obtained from all participating individuals. Patients with coagulation disorders, psychomotor disorders, active infections at the injection site, a history of shoulder surgery within the past 6 months, or known allergies to local anesthetics or corticosteroids will be excluded.
Intervention Protocol:
The ultrasound-guided shoulder PENG block is performed as a routine treatment modality in our clinic for patients non-responsive to conservative therapies. The procedure is conducted under sterile conditions with the patient in the supine position. The affected shoulder is placed in abduction and external rotation. An ultrasound transducer is positioned parallel to the clavicle to visualize the anatomical structures. A block needle is advanced under the subscapularis muscle under direct ultrasound guidance. Following the confirmation of correct needle positioning, a mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is injected into the periarticular nerve endpoints. Outcome Measurements and Data Collection:
Demographic and clinical data will be collected by an expert algologist using the hospital information management system and recorded into dedicated study forms. Clinical parameters will be evaluated at four distinct time points: baseline (pre-procedure), 1st week, 4th week (1 month), and 3rd month post-procedure. Pain severity will be measured using the Numerical Rating Scale (NRS). Shoulder joint function and disability levels will be assessed using the Shoulder Pain and Disability Index (SPADI). Overall patient satisfaction and perceived improvement will be tracked via the Global Perceived Effect (GPE) scale.
Friedman test, depending on the distribution properties. Bonferroni correction will be applied for post-hoc pairwise comparisons, and a p-value less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PENG Block Group | Experimental | Drug: Lidocaine and Dexamethasone for PENG BlockPatients with chronic shoulder pain who receive an ultrasound-guided Pericapsular Nerve Group (PENG) block. Under sterile conditions and in the supine position, with the shoulder in abduction and external rotation, an ultrasound transducer is placed parallel to the clavicle. A block needle is advanced under the subscapularis muscle. Following confirmation of the needle position, a mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is administered to the periarticular nerve endpoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Patients presenting with chronic shoulder pain lasting longer than 3 months.
- Initial pain intensity score greater than 4 on the Numerical Rating Scale (NRS > 4).
- Patients who have not responded to conservative or medical treatments.
- Voluntary acceptance of the ultrasound-guided shoulder PENG block treatment and compliance with the scheduled follow-up protocol.
Key exclusion criteria (7 listed)
- Patients currently using anticoagulants or diagnosed with coagulation disorders (bleeding diathesis).
- Patients with psychomotor or cognitive disorders that prevent cooperative evaluation.
- Presence of active bacterial infection, open wounds, or infectious discharge at the planned needle injection site.
- History of shoulder surgery at the intervention site within the last 6 months.
- Known allergy or hypersensitivity to local anesthetics (lidocaine) or corticosteroids (dexamethasone).
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 |
|---|---|---|
| Lidocaine and Dexamethasone for PENG BlockAn ultrasound-guided Pericapsular Nerve Group (PENG) block is administered to target the articular (sensory) branches of the nerves innervating the shoulder joint capsule (suprascapular, axillary, and lateral pectoral nerves) without affecting the motor branches. The intervention is performed under strict sterile conditions with the patient in the supine position. The affected shoulder is placed in abduction and external rotation. A high-frequency ultrasound transducer is positioned parallel to the clavicle to visualize the anatomical structures. Under direct ultrasound guidance, a block needle is advanced beneath the subscapularis muscle. After confirming the correct needle positioning and ensuring no intravascular placement, a therapeutic mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is injected into the periarticular nerve endpoints. | Drug | PENG Block Group |
Primary outcome
Change from Baseline Numerical Rating Scale (NRS) Score
Time frame: Baseline (pre-procedure), post-procedure 30th minute, 1st week, 4th week (1st month), and 12th week (3rd month)
The Numerical Rating Scale (NRS) is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The score ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst possible pain." Higher scores represent more severe pain intensity. Pain levels will be evaluated and compared across different time points
Change from Baseline Shoulder Pain and Disability Index (SPADI) Score
Time frame: Baseline (pre-procedure), 1st week, 4th week (1st month), and 12th week (3rd month)
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire used to measure shoulder pain and disability. It consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a visual analog scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it requires help). The total SPADI score is calculated by averaging the subscale scores and ranges from 0 to 100, where 0 indicates the best possible shoulder function (no pain and disability) and 100 indicates the worst possible shoulder function (severe pain and disability). Higher scores represent greater pain and disability
1 secondary outcome
Global Perceived Effect (GPE) Score
Time frame: Post-procedure 1st week, 4th week (1st month), and 12th week (3rd month).
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 26 May 2026.
- Background: PubMed 15163107Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Individual participant dataSharing planned: No
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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.
ali çoştu, md 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?
A study testing Lidocaine and Dexamethasone for PENG Block in people with Chronic Shoulder Pain and Pericapsular Nerve Group Block (PENG Block), run by Ankara City Hospital Bilkent 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 5 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: opening soon, as of the sponsor's last update on 26 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?
Contact ali çoştu, md (+905427669038, alicostu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Numerical Rating Scale (NRS) Score (time frame: Baseline (pre-procedure), post-procedure 30th minute, 1st week, 4th week (1st month), and 12th week (3rd month)). 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?
On the ClinicalTrials.gov record for NCT07607691, 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 26 May 2026.